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Graphical abstract | PMC10213810 | |||
Keywords | MAY | Published: May 2, 2023 | PMC10213810 | |
Introduction | glioblastoma, GBM, cancer, tumor | GLIOBLASTOMA, TUMOR GROWTH, CANCER, TUMOR | The standard of care (SOC) for glioblastoma (GBM) is a combination of surgery, radiotherapy, and concomitant temozolomide followed by maintenance temozolomide (TMZ) as demonstrated by the EORTC-NCIC trial.Due to the unpredictable nature of cancer, responses to chemotherapy can vary from patient to patient, even when ca... | PMC10213810 |
Results | deaths, glioma, physician-choice, tumor | TUMOR, RECURRENCE, MAY, BRAIN TUMORS, GLIOMA | Over a period of 3 years, 123 patients affected by rGBM or grade III glioma were screened and assessed for eligibility criteria to participate in a parallel-group-randomized controlled trial at 13 clinical sites across the US. The study protocol was approved by the Western Institutional Review Board (WIRB) and the inde... | PMC10213810 |
ChemoID assay-guided therapy increased OS and progression-free survival (PFS) of patients with rGBM | death, physician-choice | EVENTS | A statistically significant difference was observed in the risk of death between groups (hazard ratio [HR] = 0.44; 95% confidence interval [CI], 0.24–0.81; p = 0.008) in the interim efficacy analysis. In the ChemoID assay-guided group, 67% of patients (18 of 27) died vs. 87% (20 of 23) in the physician-choice group. Fu... | PMC10213810 |
Exploratory analyses | PMC10213810 | |||
ChemoID test results correlated with patients’ OS and PFS | tumor, death | TUMOR | Survival and PFS of each patient in the planned interim efficacy analysis were also analyzed as a function of the cell kill of the patient’s cultured tumor cells (both CSCs and bulk tumor cells) in response to the drug(s) used during treatment (Our analysis further revealed that for every 10% increase in CSC drug respo... | PMC10213810 |
Correlation between chemotherapy treatments administered and the ChemoID test report predictions | tumor, physician-choice | TUMOR | The drug response to each chemotherapy and their combinations were analyzed to determine the proportion of patients who benefitted from a sensitive vs. non-sensitive chemotherapy chosen prospectively by the ChemoID assay. A pyramid diagram representation of the comparison in percent of cell kill of the most cytotoxic d... | PMC10213810 |
Grade III/IV CRAEs association with chemotherapy in ITT analysis | deaths | ADVERSE EFFECTS | The relative percentage of grade III/IV chemotherapy-related adverse effects (CRAEs) in ITT analysis was lower in the ChemoID assay-guided group (51%) vs. the physician-choice group (79%), with no unexpected neurological CRAEs or deaths due to CRAEs in either arm ( | PMC10213810 |
Discussion | cancer, tumor, death, physician-choice | CANCER, TUMOR | To improve the outcome of rGBM, it is critical to use chemotherapies that are effective against the CSCs as they are proven to drive tumor development and relapse. We conducted a randomized clinical trial using the ChemoID CSC assay to guide chemotherapy for rGBM treatment. It is worth noting that patients in both arms... | PMC10213810 |
Limitations of the study | tumor, tumors | TUMOR, TUMORS | Although this study provides good treatment options for patients with rGBM, some potential limitations should be noted. For example, ChemoID is a functional assay limited by the availability of viable tumor tissue samples. Our study only included rGBM subjects who underwent surgical resection or biopsy. Subjects with i... | PMC10213810 |
STAR★Methods | PMC10213810 | |||
Key resources table | PMC10213810 | |||
Resource availability | PMC10213810 | |||
Lead contact | Further information and requests for resources and reagents should be directed to and will be fulfilled by the lead contact, Pier Paolo Claudio ( | PMC10213810 | ||
Materials availability | This study did not generate new unique reagents. | PMC10213810 | ||
Experimental model and subject details | PMC10213810 | |||
Patients | ICH, glioma, tumor | TUMOR, ADVERSE EVENTS, RECRUITMENT, MAY, GLIOMA, PATHOLOGY | 123 patients affected by recurrent GBM or grade III glioma were screened in this parallel-group randomized controlled clinical trial at 13 clinical sites across the US over a period of three years and assessed for inclusion and exclusion criteria to participate in the study (78 recurrent GBM patients were enrolled in t... | PMC10213810 |
Method details | PMC10213810 | |||
Patient treatment | tumor, death, toxicity, cancer, intercurrent illness | CANCER, TUMOR, EVENT | Lead investigators agreed on the cytotoxic chemotherapies used in the trial, and the health insurance plans covered them, thus study participants incurred no additional medical bills. The regimens and doses tested by the ChemoID drug response assay were the same as the ones that could be chosen by the physicians for pa... | PMC10213810 |
ARM 1 - Physician’s choice of chemotherapy regimens | physician-choice | Patients randomized to the physician-choice chemotherapy arm were treated with one of the regimens from the list of chemotherapies specified per the investigator’s discretion. Patients received treatment as per standard practice and continued on the treatment until hospice or as per investigator’s discretion if having ... | PMC10213810 | |
ARM 2 – ChemoID-guided drug response assay chemotherapy regimens | cancer, tumor | CANCER, TUMOR | The physician selected a treatment regimen based on ChemoID drug response assay results on cancer stem cells (CSC) and the bulk of tumor cells. Ideally, the regimen with the highest percentage cell-kill for cancer stem cells and the bulk of tumor combined was used; however, the physician had the flexibility to choose t... | PMC10213810 |
Patient follow-up | death, tumor, Tumor, seizures, ±, allergy, renal dysfunction, Cancer | ADVERSE EVENT, TUMOR, TUMOR, ADVERSE EVENTS, DISEASE, ALLERGY, ADVERSE EVENT, CANCER | Participants were followed for three years according to standard-of-care intervals by neurologic and neurosurgical clinical assessments or until death. At 6 and 12 months after planned Visit 24 there was a phone call to assess survival status.Participants were assessed at follow-up visits following standard-of-care tre... | PMC10213810 |
Clinical trial monitoring evaluations and measurements | DISEASE, PATHOLOGY | From the medical chart (paper or electronic) this additional data was collected: age, gender, weight, pathology report, steroid and other medication doses over the course of treatment, ChemoID test results, MGMT gene methylation status, IDH-1 mutation status, chemotherapy regimens including doses, all brain imaging inc... | PMC10213810 | |
Risk assessment | gliomas | RECURRENT CANCER, GLIOMAS | The ChemoID assay was classified as a non-significant risk assay for patients by the ethics committees. The current study utilized only sample specimens obtained by established procedures that patients undergo routinely for the treatment of his/her recurrent cancer; there was no additional risk to the patient. Tissue f... | PMC10213810 |
Patient tumor sample collection and processing | glioma | GLIOMA | Inclusion criteria included patients 18 and older with first-recurrence of grade III or grade IV glioma (according to the 2016-WHO guideline classification), | PMC10213810 |
Isolation of cancer cells from tumor biopsies | agitation, tumor | TUMOR, RESIDUAL TUMOR, BRAIN TUMOR, STERILE, PRIMARY TUMOR | To generate the primary tumor cell cultures, the fresh brain tumor tissue from surgical biopsies was minced using sterile scalpel blades and gently dissociated in a biosafety cabinet using 0.025% trypsin solution at 37°C for 10 min with gentle agitation and intermittent resuspension. Dissociated tumor cells were plated... | PMC10213810 |
Enrichment of cancer stem cells (CSCs) | tumor, primary cancer | TUMOR, PRIMARY CANCER | Patient-derived CSC cultures were obtained as previously described in.CSCs from primary cancer cells (bulk of the tumor cells) were enriched by loading 2x10ˆ6 bulk of tumor cells into the bioreactor and culturing them for 7- days in RPMI media in the absence of growth factors. | PMC10213810 |
Assessment of CSCs' and bulk of the tumor chemotherapy response | tumor | TUMOR | Treatments with anti-cancer drugs and sensitivity tests were performed as described previously in.96-well plates are seeded in RPMI-1640 with 10% FBS, penicillin and streptomycin with a minimum of 20,000 individual tumor cells per regimen of bulk tumor cells or CSCs in 5 replicas and incubated at 37°C in a 5% COAfter t... | PMC10213810 |
Reporting of the assay | Percent survival (potential therapeutic efficacy) was calculated relative to appropriate negative and positive controls for each treatment. Efficacy and resistance of each drug and combinations were reported on the ChemoID assay results as a continuous number from <10% to 100% cell-kill as previously. | PMC10213810 | ||
Quantification and statistical analysis | REGRESSION, SECONDARY | All statistical analyses followed the plan specified in the protocol with no deviations and were completed using Stata v17.1 (StataCorp) by independent biostatisticians. Two prespecified interim efficacy analyses were planned Baseline characteristics were compared using t-tests or Mann-Whitney U tests, as appropriate, ... | PMC10213810 | |
Baseline data | As per protocol, initial analyses involved data cleaning, variable development, and exploratory data analyses. We used standard summaries to describe baseline characteristic distributions in terms of centrality, spread, shape, and possible outliers by arm, cohort, and treatment group. Graphical explorations emphasized ... | PMC10213810 | ||
Efficacy analysis | tumor | REGRESSION, TUMOR | The primary analysis was based on an intention-to-treat approach and included all subjects randomized at baseline. The primary efficacy outcome was overall survival (OS) in months. This outcome was compared between patients randomized to ChemoID-guided chemotherapy) versus standard of care. OS comparisons were examined... | PMC10213810 |
Interim analysis | We performed a predetermined interim analysis as per protocol. From the clinical trial protocol, two interim analyses based on the alpha spending approach of Lan and DeMets could be performed. One would be performed whenever 35 patients had passed away. If both the observed HR was less than or equal to 0.55 and its rel... | PMC10213810 | ||
References | PMC10213810 | |||
Supplemental information | PMC10213810 | |||
Document S1. Figures S1–S5 and Tables S1–S5 | PMC10213810 | |||
Document S2. Article plus supplemental information | PMC10213810 | |||
Acknowledgments | We thank all of the patients and their families who participated in this study. We are grateful to all coordinators and research staff at all study sites for their contributions. The authors gratefully acknowledge Logan Lawrence, Donna McIlvain, and Veronica Mayes for technical assistance with the assay. We thank Drs. ... | PMC10213810 | ||
Author contributions | T.R., M.J.G., S.S., A.M.A., J.V., and P.P.C. designed the study. T.R., S.S., M.J.G., S.L.T., and C.M.H. drafted the manuscript. T.R., S.S., M.J.G., R.M.G., A.Y., D.A., R. Chaudhary, R. Chen, M.Z., C.L.-E., H.D.M., N.B., J.G., A.M., M.A., N.M., J.S., S.J., F.C., A.M.A., S.T.L., K.L.D., and C.M.H. carried out the investi... | PMC10213810 | ||
Declaration of interests | P.P.C. and J.V. report ownership of intellectual property rights on the CSC platform technology licensed to Cordgenics, LLC. | PMC10213810 | ||
Inclusion and diversity | One or more of the authors of this paper self-identifies as an underrepresented ethnic minority in their field of research or within their geographical location. While citing references scientifically relevant for this work, we also actively worked to promote gender balance in our reference list.Supplemental informatio... | PMC10213810 | ||
Background | RECRUITMENT | The use of decentralised clinical trials (which bring trials to patients through remote processes and technology versus central on-site visits) has been thought to be a potential solution to common recruitment and retention barriers. However, there is a lack of evidence to understand the experiences, needs and preferen... | PMC10568833 | |
Methods | Acne | ACNE | Participants of the SAFA (Spironolactone for Adult Female Acne) trial were invited to take part in a qualitative semi-structured interview to explore their experience and perspectives of taking part in the trial. Questions focused on their experience of using decentralised methods to access and enrol in the trial (e.g.... | PMC10568833 |
Results | Twelve SAFA participants (all women, age range 22–36 years) were interviewed. Initially, participants were influenced to enrol by trusted online information, the feeling of validation the trial provided, and the convenience and flexibility offered by the decentralised methods and research staff made participants feel v... | PMC10568833 | ||
Conclusions | RECRUITMENT | The study has shown that decentralised methods used by responsive and approachable staff were widely accepted in the SAFA trial. Interviewees found the methods adopted in the SAFA trial helped the trial to fit with their needs and promoted a sense of feeling valued that encouraged ongoing trial engagement. Decentralise... | PMC10568833 | |
Trial registration number | ISRCTN 12892056. Registered on October 15, 2018. | PMC10568833 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s13063-023-07630-4. | PMC10568833 | ||
Keywords | PMC10568833 | |||
Background | Acne | ACNE, RECRUITMENT, RECRUITMENT | People’s willingness to volunteer their time to participate in clinical trials is crucial to the development of evidence that advances clinical treatment and healthcare practice. Recruitment and retention of participants have continued to be two of the largest challenges to date, with over half of the trials failing to... | PMC10568833 |
Method | PMC10568833 | |||
Setting | Acne, telephone/video, acne, acne vulgaris | RECRUITMENT, ACNE VULGARIS, SECONDARY, ACNE, ACNE | This was a qualitative sub-study conducted alongside a UK primary and secondary care phase III, double-blind, placebo-controlled trial of Spironolactone for persistent (at least 6 months) facial acne vulgaris for women aged 18 and over (Spironolactone for Adult Female Acne (SAFA) trial, Fig. SAFA trial schemaThe SAFA t... | PMC10568833 |
Sampling strategy | RECRUITMENT | Participants enrolled in the SAFA trial were invited to take part in an optional qualitative interview with no monetary incentive. Participants were invited to take part opportunistically (based on their willingness and ability) by research staff at sites or by unblinding letters at 24 weeks. The total number of invite... | PMC10568833 | |
Interviews | To understand and interpret the subjective experiences and perspectives of the individuals being interviewed, and acknowledge the researcher’s role in shaping the meaning of the findings, the research questions were addressed with a constructivist approach [Three members of the research team (two students and one resea... | PMC10568833 | ||
Analysis | Reflexive thematic analysis [ | PMC10568833 | ||
Ethics | Ethical approval for the trial was granted by Wales Research Ethics Committee 3 in January 2019 (reference number: 18/WA/0420). An amendment approving the qualitative sub-study was granted in August 2021. | PMC10568833 | ||
Results | Twelve SAFA trial participants completed an interview (Table Characteristics of interview participants | PMC10568833 | ||
Theme 1: the influence of trust when deciding to enrol | ’d, I’d been reading, acne | ACNE | This first theme describes participants’ motivators for enrolling on the trial and factors that they described as important in this. Many participants had tried and tested new treatments for acne off the shelf or through their doctor, but due to a lack of effective results continued to read about possible treatment opt... | PMC10568833 |
Theme 2: the feeling of validation | ’d, acne | SAID, ACNE | This second theme describes how participants felt a sense of validation from the opportunity to take part in the SAFA trial. Many participants reported that previous treatment had been ineffective and felt that the burden of acne was not considered as serious by their GP. Access to the SAFA trial appeared to counter th... | PMC10568833 |
Theme 3: offsetting participant burden with the understanding of trial needs | dyslexia, pain, acne, ’ | MINOR, ACNE | Study participants reported an’ overwhelmingly positive experience and trust in the research staff, which often led them to overlook minor inconveniences. However, when asked directly about certain aspects of the trial, and more broadly, what could be done to improve their experience there were several suggestions. Thi... | PMC10568833 |
Discussion | acne | ACNE | This paper described the experiences of participants taking part in a partially decentralised dermatology trial [For many interview participants, their first interaction with the SAFA trial was through the social media advert. Findings from this study show that trusted affiliations and the perceived quality of the soci... | PMC10568833 |
Strengths and limitations | RECRUITMENT | The strengths of this study include its novelty and potential application and impact in practice. To our knowledge, this is one of the first trials exploring the impact of decentralised methods on participant enrolment and ongoing engagement in a dermatology trial.Some limitations of this study should be considered. We... | PMC10568833 | |
Future research | RECRUITMENT | Continued efforts should be made to understand what and how different trial conduct methods can improve accessibility and understanding to enhance trust and influence enrolment and ongoing engagement in trials.The role of infographics and videos during recruitment to improve viewer understanding is a growing area of re... | PMC10568833 | |
Conclusions | RECRUITMENT | If applied appropriately, the use of decentralised methods has the potential to influence the enrolment and ongoing participation of dermatology trial participants and help address well-known recruitment and retention issues amongst research communities [This study was aimed at women aged 18 and over, the key practical... | PMC10568833 | |
Acknowledgements | We would like to thank the participants for sharing their experiences and express our sincere gratitude to the staff who carried out the SAFA trial at recruiting centres including; hospital dermatology centres recruiting for the study: Queen Elizabeth Hospital, Birmingham; Bristol Royal Infirmary Dermatology Centre, Br... | PMC10568833 | ||
Authors’ contributions | SR, ZE, JN, AL, CW, IS and MS all contributed to the study design. IS, IM and MS were involved in the development of the topic guides. CB, AS and CC were responsible for data collection. CB, AS, CC, IM and MS conducted data analysis and interpretation of the results. All authors were involved in the preparation of the ... | PMC10568833 | ||
Funding | This project is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (Grant Reference Number: 16/13/02) and supported by NIHR CTU support funding at Southampton CTU. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department... | PMC10568833 | ||
Availability of data and materials | The datasets generated and/or analysed during the current study are not publicly available to protect the identity of the participants but are available from the corresponding author on reasonable request.The standards for reporting qualitative research and topic guides used to inform the interviews are available as su... | PMC10568833 | ||
Declarations | PMC10568833 | |||
Ethics approval and consent to participate | The SAFA trial and qualitative sub-study received a favourable ethical opinion from the Wales Research Ethics Committee (18/WA/0420) and has Health Research Authority approval (IRAS 246637).All participants provided informed consent to participate in the qualitative interview. | PMC10568833 | ||
Consent for publication | Not applicable. | PMC10568833 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10568833 | ||
References | PMC10568833 | |||
1. Introduction | URTIs, infections, upper respiratory tract infections | UPPER RESPIRATORY TRACT INFECTIONS, INFECTIONS | Bovine colostrum is considered to provide anti-infective protection. Here, we present the first randomized controlled trial (RCT) aimed at assessing the preventive use of colostrum against upper respiratory tract infections (URTIs) in healthy pre-school children. We analyzed 57 children—35 in the colostrum (COL—dried b... | PMC10459079 |
2. Materials and Methods | PMC10459079 | |||
2.1. Recruitment, Blinding and Randomization | allergy | RECRUITMENT, ALLERGY, POLAND | All trial subjects were pre-school children (3–7 years of age; mean, 4.3 ± 1.21 years; male to female ratio—1:0.8) attending one of the two large (over 300 pupils) public kindergartens facilities in Szczecin, Poland. Trial participants were invited through the advertisements posted in these facilities. The only exclusi... | PMC10459079 |
2.2. Outline of the Trial and Participation Issues | URTIs | To ensure a more coherent population, particularly in terms of exposure to infectious agents responsible for the URTIs, we included children from just two kindergartens in the trial. This helped to minimize potential variations in exposure and create a more homogenous study population. To increase the consistency of tr... | PMC10459079 | |
2.3. Supplementation Material | POLAND | The tested materials’ packages, consisting of 100 unlabeled pouches containing either COL or PBO, were provided free of charge by Genactiv Trade Sp. z o. o., Poznań, Poland. The COL sachets contained a mixture of 500 mg of freeze-dried bovine colostrum obtained within 2 h after calf delivery, mixed with 500 mg of dried... | PMC10459079 | |
2.4. Surveys | The online surveys allowed us to gather all the information on the health status and other important health-related parameters from trial participants. These surveys were provided to their parents and guardians through direct links sent via email, using the EU Survey tool [Three types of surveys were used in this trial... | PMC10459079 | ||
2.5. Outcomes | SECONDARY | Our first primary outcome was the frequency of days with any URTI symptoms (FSD—frequency of symptomatic days). This was the ratio calculated based on enumerating days with presence of any degree of URTI symptoms (1–3 URTI score) and dividing this by the number of days within the period of interest (Our second primary ... | PMC10459079 | |
2.6. Statistical Analysis | Statistical analyses were performed with the use of Med Calc statistical software version 22.110 (Ostend, Belgium). Two-sided | PMC10459079 | ||
2.7. Bioethical Approval | MAY | The trial was performed in accordance with the protocol approved by the Pomeranian Medical University Bioethics Committee (KB-006/24/2022) on 18 May 2022. | PMC10459079 | |
3. Results | PMC10459079 | |||
3.1. Study Group Characteristics | We analyzed data from 57 children—35 in the COL group and 22 in the PBO group. There were no significant differences regarding gender distribution between groups ( | PMC10459079 | ||
3.2. Colostrum Decreases Frequency of Days with URTI Symptoms | URTIs’ | The main measure of URTIs’ occurrence used in our experiment was the frequency of days with URTI symptoms (FSD) over various periods of the trial. When analyzing all days with any severity level of URTI symptoms over a period of 21 weeks from the beginning of the trial supplementation, which was the entire period of da... | PMC10459079 | |
3.3. Colostrum Reduces Average Gravity Scores of URTI Symptoms | AGS | Our second primary outcome, the average gravity score of URTI symptoms (AGS), was assessed based on reporting to daily surveys on the intensity of symptoms according to the grading scale described in the Material and Method section. Parallel to the result obtained with FSD, when this parameter was analyzed over 21 week... | PMC10459079 | |
3.4. Colostrum Reduces Number of URTI Episodes | EVENTS, SECONDARY | Due to the difficulty in defining URTI events, especially based on the self-reported URTI symptom days, we decided to use the number of URTI episodes (NUE) over the entire duration of the trial as a secondary outcome. At week 21 of the trial, there was a statistically important difference between the result obtained in... | PMC10459079 | |
3.5. Colostrum Produced No Gastrointestinal Side Effects | bloating, diarrhea, abdominal pain | Over the entire course of the trial (21 weeks), we observed no serious side effects that would lead to a discontinuation of supplementation. The reports on the symptoms (bloating, abdominal pain and diarrhea) involving the gastrointestinal tract showed no difference between the COL and the PBO groups ( | PMC10459079 | |
4. Discussion | URTIs, first-ever | GASTROINTESTINAL INFECTIONS | The evidence leading to a justified conclusion that bovine colostrum provides effective prevention against the URTIs is building up. Our results demonstrating this effect in terms of frequency and severity of URTIs in pre-school children come from the first-ever reported randomized, triple-blind, placebo-controlled tri... | PMC10459079 |
4.1. Colostrum Reduces URTI Frequency and Severity | AGS, ’ reduction, URTIs, ’ | Our two main measures of colostrum effectiveness in the prevention of URTIs were the frequency of symptomatic days (FSDs) and the URTI symptoms’ average gravity score (AGS). The information on URTI symptoms’ appearance was self-reported by parents and guardians based on a gravity scale named the URTI score (grades 0–3;... | PMC10459079 | |
4.2. URTI Episodes | common-cold | SEPARATION, EVENT | We also made an attempt to assess the number of URTI episodes over the entire trial period. However, this parameter was found to be of limited value, mainly due to the necessity of manipulating the raw data in order to manually enumerate the episodes, as well as the challenge of accurately defining URTI episodes. For t... | PMC10459079 |
4.3. How Colostrum Use May Prevent the URTIs | infection, viral infection, URTIs, infections | VIRUS, DISEASE, VIRAL INFECTION, INFECTIONS, INFECTION, SECONDARY, CYTOTOXICITY | Many experiments, of both in vitro and in vivo types, have demonstrated various influences of colostrum or its components on individual immune system elements, which may translate into a boosting of the anti-infectious resistance [The absolute majority of URTIs, even exceeding 90% of all cases, is of viral origin [Ther... | PMC10459079 |
4.4. There Were No Side Effects from Colostrum Use | bloating, gastrointestinal symptoms, diarrhea, abdominal pain | EVENTS | One of the most important concerns of investigators when introducing a novel medical procedure in children is the potential of triggering unexpected results. In the past, the use of colostrum has been blamed for causing side effects such as gastrointestinal symptoms, including abdominal pain, bloating and diarrhea. The... | PMC10459079 |
4.5. Strengths and Limitations | The strengths of our study include the following: (1) RCT design with triple blinding, (2) short duration of supplementation period critical to boost immunity and (3) continuous outcome reporting. The limitation is a relatively limited sample size. | PMC10459079 | ||
5. Conclusions | ’ reduction, gastrointestinal symptoms, URTIs | Our study provides the first solid RCT-based evidence that bovine colostrum can be effectively used to prevent and decrease the gravity of URTIs in pre-school children. The results we obtained allow us to conclude the following:Kindergarten children 4–7 years of age receiving the pre-season colostrum supplementation ma... | PMC10459079 | |
Author Contributions | Conceptualization, M.H. and M.B.-H.; data curation, M.H. and K.S.-Ż.; formal analysis, M.H. and K.S.-Ż.; funding acquisition, B.M.; investigation, M.H.; methodology, M.H.; project administration, M.H.; resources, B.M.; software, M.H.; supervision, M.H. and M.B.-H.; validation, M.H. and K.S.-Ż.; visualization, M.H. and ... | PMC10459079 | ||
Institutional Review Board Statement | MAY | The trial was performed in accordance with the protocol approved by the Pomeranian Medical University Bioethics Committee (KB-006/24/2022) on 18 May 2022. | PMC10459079 | |
Informed Consent Statement | Written informed consent was obtained from the patient(s) caregivers to publish this paper. | PMC10459079 | ||
Data Availability Statement | Data are available upon request. | PMC10459079 | ||
Conflicts of Interest | POLAND | The authors declare the following financial interest/personal relationship which may be considered a potential competing interest: Maciej Hałasa receives renumeration from Genactiv Trade, Poznań, Poland—the manufacturer of COL. | PMC10459079 |
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