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IRCT20200915048727N1 IRCT 2020-10-16 Shahid Beheshti University of Medical Sciences Effect of probiotic in irritable bowel syndrome Effects of supplementation with a multi-species probiotic formulation (BioIBS®) on severity of symptoms and quality of life in patients with irritable bowel syndrome 2020-10-22 anticipated 60 Complete https://irct.ir/trial/50947 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will occur centrally using an phone randomization system by an independent researcher. There are two treatment arms.Randomization in the mentioned groups will be conducted according to permuted block randomization based on basis of 4 and 6 blocks, Blinding description: Probiotic and placebo capsules will be provided by Tak Gene Zist. Probiotic and placebo capsules in boxes numbered according to randomization sequence for each group of patients will be provided by Tak Gene Zist. Probiotic and placebos capsules will be packed in similar boxes, and researchers and patients will not know the contents of the packages until the end of the study. 3 Irritable bowel syndrome (IBS). Intervention 1: Intervention group: : probiotic capsule (Bio IBS®, Takgene zist , Iran) containing L. rhamnosus, L. casei, L. acidophilus. Each capsule containing 5×109 cfu ⁄capsule. 2 capsules per day, Duration 2 months. Intervention 2: Control group: placebo capsule (Takgene zist, Iran). 2 capsules per day, Duration 2 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is Patient information is kept confidential and will not be published
public Abbas Yadegar
Taleghani Hospital, Shahid Arabi St.,Velenjak, Tehran
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2243 2518 a.yadegar@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Abbas Yadega
Taleghani Hospital, Shahid Arabi St.,Velenjak, Tehran
Tehran Iran (Islamic Republic of) 198511151 +98 21 2243 2518 a.yadegar@sbmu.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Presence of Rome IV diagnostic criteria for IBS male and female subjects in age range of 18-75 years. 18 years 75 years Both Anemic subjects with Hb < 10 g/dl. Subjects with organic disease (to be ruled out by physician based on prior history and physical examination). Subjects with a history of surgical resection of the stomach, small intestine or large intestine. Subjects with a history of or complications from inflammatory bowel disease (Crohn's disease or ulcerative colitis) and ischemic colitis. Subjects with complications from infectious enteritis, hyperthyroidism or hypothyroidism. Subjects with a history of any diet-based intolerance (gluten or lactose intolerance). Subjects who are pregnant or planning on becoming pregnant throughout the course of the study. Subjects with uncontrolled Type II diabetes mellitus. Subjects who are immuno-compromised Subjects who have used an over-the-counter or prescription laxative medication or any other herbal agents affecting GI motility within 2 weeks prior to screening. Subjects who have used probiotic or fiber supplements (or probiotic/fiber enriched foods) or an antibiotic within 4 weeks prior to screening. Subjects who have used IBS specific treatments within 4 weeks prior to screening. Subjects who have participated in a clinical research trial within 30 days prior to randomization. K58 Irritable bowel syndrome Treatment - Drugs Placebo Intervention group: : probiotic capsule (Bio IBS®, Takgene zist , Iran) containing L. rhamnosus, L. casei, L. acidophilus. Each capsule containing 5×109 cfu ⁄capsule. 2 capsules per day, Duration 2 months. Control group: placebo capsule (Takgene zist, Iran). 2 capsules per day, Duration 2 months. Changes in severity of IBS symptoms (IBS-SSS). Timepoint: At baseline, 4 and the 8 weeks after the intervention. Method of measurement: Questionnaire (IBS, Symptom Severity Scoring). Quality of life. Timepoint: At baseline,4 and the 8 weeks after the intervention. Method of measurement: IBS-QOL-34. Adequate Relief. Timepoint: At baseline,4 and the 8 weeks after the intervention. Method of measurement: IBS, Adequate Relief (IBS, AR). Improvement or worsening of IBS global symptoms (IBS-GIS). Timepoint: At baseline, 4 and the 8 weeks after the intervention. Method of measurement: Global Improvement Scale (IBS-GIS). Malondialdehyde (MDA). Timepoint: At baseline, and the 8 weeks after the intervention. Method of measurement: Thiobarbituric Acid assay. Total antioxidant capacity (TAC). Timepoint: At baseline, and the 8 weeks after the intervention. Method of measurement: Colorimetric method. IL-6. Timepoint: At baseline, and the 8 weeks after the intervention. Method of measurement: ELISA. INF-ɣ. Timepoint: At baseline, and the 8 weeks after the intervention. Method of measurement: ELISA. IL-10. Timepoint: At baseline, and the 8 weeks after the intervention. Method of measurement: ELISA. Gut microbiom. Timepoint: At baseline, and the 8 weeks after the intervention. Method of measurement: Real-time PCR (qPCR) assay. Takgene zist Approved 2020-10-05 Ethics Committee of Shahid Beheshti University of Medical Sciences Velenjak Ave,Taleghani Hospital,Tehran Tehran Tehran Iran (Islamic Republic of)