NCT06317441

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Nimble Science Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to test the effect of a probiotic formulation on gastrointestinal symptoms, gut and small intestine microbiota in participants suffering from small intestinal bacterial overgrowth (SIBO). Two doses of probiotic will be evaluated against placebo.

Detailed description

The goal of this double-blinded, randomized, placebo-controlled clinical study is to evaluate whether two different doses of a probiotic formulation may have effect on gastrointestinal symptoms, as well as gut and small intestine microbiota, in participats suffering from SIBO. The two probiotic doses will be compared to a placebo. The main research questions to be answered by this study are related to: * Probiotic effect on bloating and abdominal distension. * Probiotic effect on other gastrointestinal symptoms. * Probiotic effect on incidence of SIBO. * Probiotic effect on small intestine and gut microbiota. The study will include a 2 month intervention with the investigational products and assessments will be conducted at baseline, mid-intervention, end-of-intervention, and follow-up period, with the exception of SIBO diagnosis, which will be conducted at baseline and at follow-up.

Conditions

• Small Intestinal Bacterial Overgrowth
• SIBO

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	The intervention consists of a probiotic either with a low or high dosage

Timeline

• Start date: 2024-07-20
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-03-19
• Last updated: 2025-04-29

Locations

1 site across 1 country: Canada