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Discussion | hypoparathyroidism, normocalcemia, hypercalcemia, PaTHway, hypocalcemia | DISEASE, HYPOPARATHYROIDISM, HYPERCALCEMIA, SECONDARY, ADVERSE EVENT, HYPOCALCEMIA | In this randomized trial of women and men with chronic hypoparathyroidism, PTH replacement therapy with TransCon PTH robustly improved and maintained mean serum calcium levels in the normal range at all study visits, while allowing independence from conventional therapy. Treatment with TransCon PTH additionally resulte... | PMC10099823 |
Disclosures | LGA, CM, LCH, CTS | AAK: Research investigator for Alexion, Amgen, Ascendis, Chugai, Radius, Takeda, and Ultragenyx. MRR: Research investigator for Ascendis Pharma Inc. PS: Research investigator for Ascendis Pharma A/S. TJV: Advisory board member for Takeda; receives consulting fees from Ascendis Pharma Inc.; and research investigator for... | PMC10099823 | |
Author Contributions | PMC10099823 | |||
Supporting information |
Click here for additional data file. | PMC10099823 | ||
Acknowledgments | BONE DISEASES | This work was supported by Ascendis Pharma Bone Diseases A/S, Hellerup, Denmark. The ClinicalTrials.gov number is NCT04009291. The authors thank the trial participants and their families, investigators, and the trial staff. Medical writing support was provided by Kristin Hirahatake, PhD, and Nayna Sanathara, PhD, of As... | PMC10099823 | |
Data Availability Statement | The data sets generated during and/or analyzed during the present study are not publicly available but are available from the corresponding author on reasonable request. | PMC10099823 | ||
References | PMC10099823 | |||
Abstract | PMC10467537 | |||
Introduction/Objective | DISEASE, ANKYLOSING SPONDYLITIS | Newly created systems called hippotherapy simulators (HS) mimic the primitive movements of a live horse. As they are new systems, research examining their usefulness has been well received. The aim of this study is to research the effects of HS on disease activity, quality of life and muscle strength in patients with a... | PMC10467537 | |
Methods | ANKYLOSING SPONDYLITIS, DISEASE | In a prospective, assessor-blinded, block-randomized trial, 48 AS patients were randomly assigned in a 1:1 ratio to receive either HS or conventional home (CH) exercise therapy. All Participants received 48 sessions, that is 4 sessions a week for 12 consecutive weeks. The primary outcome measures included the quadricep... | PMC10467537 | |
Results | Both groups demonstrated significant improvement in BASDAI, BASFI, BASMI, ASQoL and muscle strength scores compared to the baseline ( | PMC10467537 | ||
Conclusions | DISEASE | The results of this clinical trial of HS exercises for AS patients indicate a positive effect on disease activity, quality of life and muscle strength. Therefore, horse-riding simulator exercises can be used as an alternative method for the management of individuals with AS. | PMC10467537 | |
HIGHLIGHTS | ankylosing | DISEASE, ANKYLOSING SPONDYLITIS, CHRONIC INFLAMMATORY DISEASE |
Hippotherapy simulator exercises indicate a positive effect on disease activity, functionality and muscle strength in people with ankylosing spondylitisFor people with ankylosing spondylitis, hippotherapy simulator exercises are a safe workout for the spine that uses the core muscles.For people with ankylosing spondyl... | PMC10467537 |
Keywords | PMC10467537 | |||
Clinical trials number: | PMC10467537 | |||
Introduction | pain | DISEASE, ANKYLOSING SPONDYLITIS | People with Ankylosing Spondylitis (AS) experience joint stiffness and pain that mainly affects the spine, hips and shoulders [Horseback riding is recommended as a form of exercise as it has been shown to offer therapeutic advantages [The aim of this study is to research the effects of HS on disease activity, quality o... | PMC10467537 |
Patients and the method | PMC10467537 | |||
Design and participants | heart, kidney and respiratory disease, word of mouth, necrosis | RECRUITMENT, NECROSIS | This prospective study was conducted as a randomized trial with parallel groups in a single-center. The setting of this quantitative study was the outpatient clinic of the physical medicine and rehabilitation department of a university hospital (University of Usak (Turkey)) between September 2020 and February 2022.Afte... | PMC10467537 |
Randomization and blinding | Participants who met the inclusion criteria were randomized to HS or conventional home (CH) exercise groups. A statistician blinded to the study prepared the computerized random allocation sequence with different block sizes. Furthermore, to ensure that gender and age were similarly represented, random assignment to th... | PMC10467537 | ||
Interventions | ®, abduction, ’ | SEMI, ANKYLOSING SPONDYLITIS, STRETCHES | Participants in both exercise groups received 48 exercise sessions (40 min each), that is 4 sessions a week for twelve consecutive weeks. In both types of exercise, each session consisted of a five-minute warm-up, including side lunges, side stepping, half squat, biceps, triceps and deltoid warm-up exercises, and self-... | PMC10467537 |
Outcome measurements | Disability, quadriceps muscle, fatigue | DISEASE, DISEASE, ANKYLOSING SPONDYLITIS | For a comprehensive analysis, outcome measures were chosen to document changes in muscle strength, disease activity, spinal mobility and quality of life across different components of the International Classification of Functioning, Disability and Health, including activity, body structure and function. Primary outcome... | PMC10467537 |
Quadriceps muscle strength testing | Quadriceps muscle strength was tested with a microFET-2 dynamometer. Reliability and quantifiable force evaluation tests (Hogan Health Industries, Inc., UT, USA) were performed with this portable (wireless) handheld dynamometer [The subject was seated in an upright position with arms folded across the chest and no lumb... | PMC10467537 | ||
BASDAI | tenderness, morning stiffness, fatigue, pain | DISEASE, THIGH DISEASE | The patient was asked to answer six questions regarding the five main symptoms of AS (fatigue, spinal pain, joint pain, tenderness, pain intensity and morning stiffness) over the past week. These self-administered questions are on a 0–10 scale and the resulting score of 0 to 50 is divided by five to obtain the final BA... | PMC10467537 |
BASFI | Ten questions comprising the BASFI were asked to assess patients’ activities related to their functional and anatomical limitations. A ten-point visual analog scale (zero being ‘easy’ and ten being ‘impossible’) was used to score each question, and the BASFI score (a value between 0 and 10) was obtained from the averag... | PMC10467537 | ||
BASMI | hip mobility (intermalleolar distance) | The BASMI was used to assess the effect of exercise interventions on spinal mobility. This scale ranges from 0 to 10, with lower scores indicating less mobility limitation and 10 indicating very severe limitation. Four measures of spinal mobility (tragus-to-wall distance, cervical rotation, lumbar lateral flexion and m... | PMC10467537 | |
ASQoL | pain | ANKYLOSING SPONDYLITIS | The 18-item Ankylosing Spondylitis Quality of Life (ASQoL) instrument was used as a reliable tool to assess the impact of exercise interventions on pain, mood, sleep, motivation and ability to cope with daily tasks, relationships, self-image and self-esteem. Higher scores on these Yes/No questions indicate poorer quali... | PMC10467537 |
Sample size calculation | The number of participants included in this study was determined based on quadriceps muscle test data from a previously published study. According to the results of Ogut et al. the mean muscle strength before treatment was 40.6 Nm with a standard deviation of 6.5. The mean muscle strength after treatment was 44.8 Nm. T... | PMC10467537 | ||
Statistical analysis | ® | Data analysis was performed using IBM® SPSS® statistics 17.0 software (SPSS Inc. Released 2008. SPSS Statistics for Windows, Version 17.0. Chicago). The normal distribution of variables was examined using the Kolmogorov-Smirnov test, which was suitable for our sample sizes. Median, minimum and maximum values and percen... | PMC10467537 | |
Results | ADVERSE EFFECTS, ANKYLOSING SPONDYLITIS, DISEASE | Forty-eight people with AS participated in this study. Six patients dropped out due to inability to participate in exercise sessions (The mean age for the entire cohort was 34.9 years and 64.2% of the cohort was male. The groups were similar and there was no significant difference between the two groups in terms of dem... | PMC10467537 | |
Discussion | ’ differing disease severity, exercise frequency, pain | ADVERSE EVENTS, DISEASE | This study demonstrated that 48 sessions of hippotherapy simulation workouts significantly improved functionality, muscle strength and quality of life in individuals with AS leading a sedentary lifestyle. Comparing the treatment approaches, daily activity scores, functionality and spinal mobility showed a statistically... | PMC10467537 |
Conclusion | DISEASE | The results of this first randomized clinical trial of HS exercises for AS patients indicate a positive effect on disease activity, quality of life and muscle strength. Thus, the social advantage of this clinical trial is the opportunity to introduce a novel recreational exercise approach for AS patients. The possibili... | PMC10467537 | |
Author contributions | Ender Salbaş: Conceptualization, Methodology, Formal analysis, Investigation, Resources, Writing – original draft, Writing – review & editing.Ali Yavuz Karahan: Conceptualization, Methodology, Formal analysis, Investigation, Resources, Writing – original draft, Writing – review & editing. | PMC10467537 | ||
Ethics statement | The study was conducted in accordance with the Declaration of Helsinki, and approved by the Usak University research Ethics Committee for studies involving humans (ID: 38824465-020). This study was registered in the | PMC10467537 | ||
Patient consent | Informed consent was obtained from all subjects involved in this study. Written informed consent has been obtained from the all participant to publish this paper. The individual gave his explicit written consent for photos in Figures. Written consents retained by the author might be provided to Editor on request. | PMC10467537 | ||
Disclosure statement | The authors declare no conflict of interest. | PMC10467537 | ||
References | PMC10467537 | |||
1. Introduction | Caffeine is an adenosine ATraining, nutrition, motivation, and genetics (talent) are key factors in achieving high levels of athletic performance [Adenosine is one of the metabolites produced by dephosphorylation of the Adenosine Triphosphate (ATP) via 5-nucleotidease enzyme during the exercise [Research suggests that ... | PMC10097079 | ||
2. Materials and Methods | PMC10097079 | |||
2.1. Ethics Statement | The Institutional Review Board of the Faculty of Humanities and Social Science (No. 1314796, 08.10.95) and Iran National Committee for Ethics in Biomedical Research at University of Kurdistan (IR.UOK.REC.1398.047) and the Ethics Committee of the Federal Research and Clinical Center of Physical-Chemical Medicine of the ... | PMC10097079 | ||
2.2. Participants | PMC10097079 | |||
2.2.1. Resistance Exercise Study | Fifteen resistance-trained Iranian men were randomly selected to participate in the randomized, double-blind, placebo-controlled study. Physical characteristics of 15 male subjects with different | PMC10097079 | ||
2.2.2. Habitual Coffee Intake Study | A total of 134 Russian healthy (non-smokers), physically active (>3 training sessions per week) subjects (45 females, age 28.4 (7.1) years, height 168.0 (5.9) cm, weight 59.5 (6.1) kg; 89 males, age 31.4 (8.6) years, height 179.8 (6.2) cm, weight 80.2 (10.3) kg) participated in this study. | PMC10097079 | ||
2.3. Resistance Exercise Study Design | One week before starting the experimental session, maximal strength was assessed by one Repetition Maximum (1RM) test in bench press, leg press, seated cable row, and shoulder press. Participants were asked to abstain from performing the exercise 3 days before the 1RM test and experimental sessions, and to avoid consum... | PMC10097079 | ||
2.4. Assessment of Habitual Coffee Intake | Habitual coffee intake was assessed using a dietary questionnaire administered to all participants. Responses to the questions on coffee were assigned values for frequency per week (never = 0, once per week = 1, 2–3 times per week = 3, 4–5 times per week = 5, and once or more a day = 7). | PMC10097079 | ||
2.5. Biochemical Analysis | SEPARATION | After sampling, 5 mL of venous blood was used for serum separation. Serum samples were stored at −20 °C until the day of analysis. The ELISA method was used for analyzing the activity of myeloperoxidase (MPO) and acetylcholinesterase enzymes (AchE) in Iranian subjects (ELISA Kit, Eastbiopharm, Hangzhou, Zhejiang, China... | PMC10097079 | |
2.6. Genotyping | PMC10097079 | |||
2.6.1. Resistance Exercise Study | After sampling, 2 mL of blood was injected in K2EDTA-containing Venoject for DNA extraction (TIANamp Genomic DNA) to study the Single-Nucleotide Polymorphism (SNP) in The thermal protocol for PCR operation consisted of step (1) the primary denaturation for 10 min at 94 °C, step (2) second denaturation for 1 min at 94 °... | PMC10097079 | ||
2.6.2. Habitual Coffee Intake Study | Molecular genetic analysis was performed with DNA samples obtained from leukocytes (venous blood). Four ml of venous blood were collected in tubes containing EDTA (Vacuette EDTA tubes, Greiner Bio-One, Kremsmünster, Austria). DNA extraction and purification were performed using a commercial kit according to the manufac... | PMC10097079 | ||
2.7. Statistical Analysis | REGRESSION | Statistical analyses were conducted using Statistical Package for the Social Sciences (SPSS) for Windows v21.0 (IBM Crop, Armonk, NY, USA) or GraphPad InStat (GraphPad Software, Inc., San Diego, CA, USA) software. A 2 × 2 × 3 general linear model repeated measures ANOVA was used to examine acetylcholinesterase and myel... | PMC10097079 | |
3. Results | PMC10097079 | |||
3.1. Association of ADORA2A Variant with Anti-Inflammatory Effects of Caffeine in Response to Intense Resistance Exercise | No significant differences were determined in age, height, weight, soft lean mass, body fat mass, percent body fat, body mass index, and basal metabolic rate between the carriers of the Repeated measures ANOVA revealed a significant genotype (TT vs. CT/CC) × time (pre, post, and 15 min post) interaction effect in caffe... | PMC10097079 | ||
3.2. Association of ADORA2A Variant with Habitual Coffee Intake | In 134 physically active Russian individuals (TT: 22, CT: 53, CC: 59), the | PMC10097079 | ||
Author Contributions | Conceptualization, M.R.R. and I.I.A.; methodology, M.R.R. and I.I.A.; formal analysis, M.R.R., E.A.S., I.I.A. and H.G.; funding acquisition, B.Ł.; investigation, M.R.R., E.A.S., A.K.L., N.A.K., E.V.G., I.I.A. and H.G.; validation, B.Ł.; writing—original draft preparation, M.R.R., I.I.A. and H.G. All authors have read a... | PMC10097079 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki, and approved by the Institutional Review Board of the Faculty of Humanities and Social Science (No. 1314796, 08.10.95) and Iran national committee for ethics in biomedical research at University of Kurdistan (IR.UOK.REC.1398.047), and by the Ethics... | PMC10097079 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10097079 | ||
Data Availability Statement | The data presented in this study are available on request from the corresponding authors. | PMC10097079 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10097079 | ||
References | AChE response to resistance exercise in athletes with MPO response to resistance exercise in athletes with Physical characteristics of the subjects with Values are Mean ± SD, there were no significant differences between group.Percent change of MPO and AChE levels in caffeine and placebo condition in C, caffeine group;... | PMC10097079 | ||
Abstract: | This article has supplementary material on the web site: | PMC10686276 | ||
Objective: | GDM | GDM, GESTATIONAL DIABETES MELLITUS | We compared cognitive profile and neuropsychological performance in 9-year-old offspring of mothers who were treated with metformin or insulin for gestational diabetes mellitus (GDM). | PMC10686276 |
Methods: | calculus, GDM | GDM | A total of 172 children whose mothers were randomly assigned to receive either metformin or insulin for GDM were studied at the age of 9 years. Of these children, 127 were from Turku, Finland (63 metformin and 64 insulin), and 45 from Oulu, Finland (19 metformin and 26 insulin). Clinical and demographic background char... | PMC10686276 |
Results: | The cognitive profiles, including indexes of verbal comprehension, perceptual reasoning, working memory, and processing speed, did not differ significantly between metformin-treated and insulin-treated groups. Significant differences were not found between the treatment groups in assessed neuropsychological functions, ... | PMC10686276 | ||
Conclusion: | GDM | GDM | Cognitive and neuropsychological outcomes were similar in 9-year-old children whose mothers had either metformin or insulin treatment of GDM. | PMC10686276 |
Index terms: | hyperglycemia, GDM | GDM, HYPERGLYCEMIA, GESTATIONAL DIABETES MELLITUS | Gestational diabetes mellitus (GDM) is defined as a condition in which hyperglycemia develops and is diagnosed for the first time during pregnancy.Metformin is increasingly used in the treatment of GDM. However, metformin crosses the placenta with fetal levels similar to maternal concentrations.Mice studies have shown ... | PMC10686276 |
METHODS | PMC10686276 | |||
Study Subjects | calculus, GDM | GDM, SYNDROME, GESTATIONAL DIABETES MELLITUS | This was a prospective follow-up study in the offspring of 2 previously published Finnish randomized controlled trials with similar study designs,Participants of the 2 original randomized controlled trials and those of the 9-year follow-up study. †Of the 110 participants, who completed the original study in the metform... | PMC10686276 |
Cognitive and Neuropsychological Assessments | Neuropsychological test battery for the purposes of this study was designed to cover essential functions of development and school performance of 9-year-old children. Neuropsychological assessments were performed in Finnish. Two psychologists and 3 final-stage psychology students under the guidance of an experienced ps... | PMC10686276 | ||
Data Analysis | Owing to a relatively small number of children in both study groups, post hoc power analysis was performed to evaluate the reliability of the results. Assuming at least noninferiority between the study groups, the required sample sizes were calculated to attain 80% statistical power on 95% significance level with 10 po... | PMC10686276 | ||
RESULTS | PMC10686276 | |||
Study Subjects | GDM | GDM, HYPOGLYCEMIA, GESTATIONAL DIABETES MELLITUS | A total of 172 children (82 in the metformin group and 90 in the insulin group) were followed up at 9 years. The means or medians of cognitive development, neuropsychological performance, and academic functioning were similar in offspring assessed in the 2 study sites (Turku n = 127, Oulu n = 45), which allowed further... | PMC10686276 |
Cognitive Development at the Age of 9 Years | calculus, GDM | GDM, GESTATIONAL DIABETES MELLITUS | The results of Full-Scale Intelligence Quotient, Verbal Comprehension Index, PRI, Working Memory Index, and Processing Speed Index between metformin and insulin groups were similar (Table Cognitive Development, Neuropsychological Performance, and Academic Functioning at the Age of 9 yrPsychological assessments were per... | PMC10686276 |
Neuropsychological and Academic Functions at the Age of 9 Years | GDM, GESTATIONAL DIABETES MELLITUS | The results of the 2 subtests of NEPSY II, TMT A-time and B-time, and reading fluency test by LUKILASSE were similar in the children of the metformin and insulin groups (Table Executive Functioning in Daily Life at the Age of 9 yr as Assessed by the Teacher and ParentMedians of BRIEF indexes and proportion of children ... | PMC10686276 | |
DISCUSSION | cognitive and neuropsychological difficulties, fifty-nine 9-year-old, GDM, PCOS | GDM, POLYCYSTIC OVARY SYNDROME (PCOS) | In this follow-up study, which comprised one hundred fifty-nine 9-year-old children born to mothers with GDM, we found no statistically significant differences in cognitive or neuropsychological outcomes between the offspring of mothers who were treated with either metformin or insulin.It has been shown that metformin ... | PMC10686276 |
Supplementary Material | PMC10686276 | |||
ACKNOWLEDGMENTS | Diabetes | DIABETES | The authors acknowledge Tommi Kauko for statistical advice and support. The authors especially thank study nurse Ulla Torkko and study nurse Tiina Latva-aho for organizing the study visits. The authors acknowledge psychologist Annarilla Ahtola, Ph.D., who was important in designing cognitive and neuropsychological asse... | PMC10686276 |
REFERENCES | PMC10686276 | |||
Background: | bloating, Gut microbiome dysbiosis | Gut microbiome dysbiosis is a major cause of abdominal gas, bloating, and distension. | PMC9982755 | |
Methods: | bloating | Multicenter, randomized, double-blind, placebo-controlled study at hospitals in southern India. Seventy adults with functional gas and bloating with a gastrointestinal symptom rating scale (GSRS) indigestion score ≥ 5 were randomized to receive | PMC9982755 | |
Results: | Two participants from each group withdrew from the study and 66 participants (n = 33 in each group) completed the study. The GSRS indigestion scores changed significantly ( | PMC9982755 | ||
1. Introduction | pelvic floor dysfunction, bloating, dyspepsia, abnormal intestinal gas transit, Functional bowel disorders, SIBO, IBS, Abdominal bloating, constipation, FBD | HYPERSENSITIVITY, SMALL INTESTINAL BACTERIAL OVERGROWTH | Functional bowel disorders (FBD) are highly prevalent, affecting all facets of society globally. They reduce people’s quality of life and have a negative impact on the global health care system.Although the etiology of bloating and distension is not well understood, small intestinal bacterial overgrowth (SIBO), gut mic... | PMC9982755 |
2. Materials and methods | PMC9982755 | |||
2.2. Gastrointestinal symptom rating scale | nausea, loose stools, flatulence, heartburn, Dyspepsia, burping, Abdominal Pain, Diarrhea, constipation, Abdominal pain, borborygmi, gastrointestinal symptom rating scale (GSRS), gastric hunger pain | GI DISORDERS, SYNDROME, REFLUX | The gastrointestinal symptom rating scale (GSRS) is a 15-item questionnaire to assess the common symptoms associated with GI disorders. GSRS utilizes a 7-level Likert scale (0–6) depending on the intensity and frequency of GI symptoms experienced during the previous week. It is divided into 5 subscales. Abdominal pain,... | PMC9982755 |
2.3. Ethics and study design | The trial was conducted as a prospective, randomized, double-blind, placebo-controlled at 2 investigative sites in Bangalore (MS Ramaiah Medical College and Hospitals and Santosh Hospital) between August 2019 and March 2021. The Institutional Ethics Committees of both sites approved the study. Written informed consent ... | PMC9982755 | ||
2.4. Sample size | The study statistician calculated the sample size based on earlier studies using a power of 80% and an alpha significance of 0.05, and correlation of 0.32, the required total sample size was calculated to be 60 for evaluation. Considering a 15% drop out rate, 70 participants were recruited and randomized in a 1:1 ratio... | PMC9982755 | ||
2.5. Inclusion and exclusion criteria | bloating, dyspepsia, ulcerative colitis, IBS, postprandial distress syndrome, constipation, abdominal bloating/distension, ; active psychiatric, gastrointestinal disorders, abdominal bloating | LACTOSE INTOLERANCE, POSTPRANDIAL DISTRESS SYNDROME, ULCERATIVE COLITIS, CROHN DISEASE, FUNCTIONAL DIARRHEA, FUNCTIONAL GASTROINTESTINAL DISORDER, FUNCTIONAL CONSTIPATION, GASTROINTESTINAL DISORDERS | The study included adult (18–65-year-old) male and female participants experiencing abdominal discomfort, gas, bloating, and distension symptoms. The enrolled subjects fulfilled Rome IV C4 diagnostic criteria for functional abdominal bloating/distension. Rome IV C4 diagnostic criteria consist of recurrent bloating and/... | PMC9982755 |
2.6. Randomization, blinding, and intervention | Subjects were randomized using computer-generated random allocation software (STATA Software version 16.0, StataCorp LLC, College Station, TX). An alphabetic code was generated for both the | PMC9982755 | ||
2.7. Outcome measures | burping | ADVERSE EVENTS, SECONDARY, BRAIN | The participants completed all the 15 questions in the GSRS questionnaire. Three questions related to feeling bloated, bothered by burping and passing gas or flatus were considered as indigestion subscale. The primary outcome was the change in the cumulative indigestion score from screening to end of the study. Change ... | PMC9982755 |
2.8. Statistical analysis | All the statistical analysis was performed by STATA Software version 16.0. The GSRS Indigestion subscale score, global evaluation of patient scores, and other cumulative subscale scores in the GSRS questionnaire were represented as continuous variables.A comparative analysis was performed for normally distributed data ... | PMC9982755 | ||
3. Results | PMC9982755 | |||
3.1. Demographic characteristics | abdominal bloating | A total of 87 subjects were screened, at the participating hospitals for the presence of functional abdominal bloating as per the inclusion/exclusion criteria, and 70 (29 males and 41 females) were enrolled and randomized to the Baseline demographics and vitals.Mean ± SD, (Min, Max) values are given for the baseline de... | PMC9982755 | |
3.1.1. Primary outcome parameters. | PMC9982755 | |||
3.2. Secondary outcomes | PMC9982755 | |||
3.2.1. GSRS scores (excluding indigestion subscale). | diarrhea, abdominal pain, constipation, diarrheal, subscale).Comparison, reflux syndrome | The GSRS cumulative scores for abdominal pain, reflux syndrome, diarrhea, and constipation subscales significantly improved in individuals consuming Cumulative GSRS questionnaire (excluding indigestion subscale).Comparison of cumulative GSRS Questionnaire, including abdominal pain, reflux syndrome, diarrheal, and const... | PMC9982755 | |
3.2.2. Safety assessment. | PMC9982755 | |||
3.2.2.1. Brain fog questionnaire | SIBO | In some studies, use of probiotics has been reported to be associated with brain fog in SIBO patients. The brain fog questionnaire was included and analyzed in the study as part of the safety outcome. One subject with brain fog in the | PMC9982755 | |
3.2.3. Safety parameters. | ADVERSE EVENTS, ADVERSE EVENT | One participant from the Summary of adverse events for all subjects.A total of 70 subjects were enrolled and 66 subjects completed the study. One subject in SAE = serious adverse event. | PMC9982755 | |
5. Conclusion | bloating, gastrointestinal disorders | GASTROINTESTINAL DISORDERS | Gas and bloating symptoms are common signs of gastrointestinal disorders affecting a larger population. | PMC9982755 |
Acknowledgments | We would like to thank the investigators, Dr Manjunath Patil and Dr Santosh Saklecha, and the entire clinical research team from the Sami-Sabinsa group, MS Ramaiah Medical College and Hospitals, and Santosh Hospital, Bangalore. The authors thank the statistician Mr. Kamal Kammili, M/s. Sanjeevani Bio Services Pvt. Ltd.... | PMC9982755 | ||
Supplementary Material | PMC9982755 | |||
Abbreviations: | functional bowel disordersgastrointestinalgastrointestinal symptom rating scaleirritable bowel syndromesmall intestinal bacterial overgrowthSupplemental Digital Content is available for this article.Trial registration: CTRI/2019/06/019617.The authors have no funding to disclose.All the authors are employees of Sami-Sab... | PMC9982755 |
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