Irritable bowel syndrome (IBS). Irritable bowel syndrome
Conditions
Interventions
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 da
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Presence of Rome IV diagnostic criteria for IBS male and female subjects in age range of 18-75 years.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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-?. 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAbbas Yadegar
Shahid Beheshti University of Medical Sciences
Outcome results
None listed