Testing the Safety and Effectiveness of Two Doses of a Probiotic Compared to Placebo in Adults Aged 18 to 65 with Small Intestinal Bacterial Overgrowth and Related Digestive Symptoms

What this Trial Is About

Researchers are evaluating the effects of a probiotic formulation on gastrointestinal symptoms and the gut and small intestine microbiota in adults with small intestinal bacterial overgrowth SIBO. This double-blinded, randomized, placebo-controlled study aims to compare two different probiotic doses to a placebo. Key questions include the probiotics impact on bloating, abdominal distension, other digestive symptoms, SIBO incidence, and microbiota changes. The study involves a 2-month intervention where participants receive either a high dose probiotic, a low dose probiotic, or a placebo capsule. Assessments occur at baseline, mid-intervention week 4, end of intervention week 8, and a follow-up period week 12. SIBO diagnosis is evaluated at baseline and follow-up. The probiotic capsules are size-00, and participants are expected to maintain their usual diet and physical activity during the trial. Participants will complete symptom assessments including bloating severity, abdominal discomfort, stool frequency and consistency, reflux, quality of life, and IBS symptoms throughout the study. Microbiome samples from the small intestine, feces, and saliva will be collected to analyze bacterial populations. Safety and probiotic strain recovery rates are also monitored. The total study duration includes up to one year for microbiome and SIBO association investigations.

The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms