Effects of supplementation with a multi-species probiotic formulation (BioIBS®) on severity of symptoms and quality of life in patients with irritable bowel syndrome

Inclusion criteria:

Presence of Rome IV diagnostic criteria for IBS male and female subjects in age range of 18-75 years.

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.

Target sample size: 60