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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNimble Science Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Aged 18-65 years old at the inclusion of the study, both female and male subjects.

Signed Informed Consent; willing and able to comply with study procedures.

Willing to maintain their diet and physical activity levels during the study.

Able to swallow a size-00 capsule (23mm length and 9mm width).

Disqualifiers

History of less than three (3) bowel movements per week.

With the diagnosis of IBS-C.

Prior gastrointestinal disease, surgery, or abdominal or pelvic radiation treatment which, in the Investigator's opinion, would lead to intestinal structuring or obstruction with a risk of capsule non-excretion, including, e.g., achalasia, eosinophilic esophagitis, any IBD, or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months before the screening visit is acceptable.

Persons with central venous catheters.

Trial design

Treatments tested in this trial

  • Probiotic

Treatment groups

105 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Nimble Science Ltd.

Lead sponsor

Lallemand Health Solutions

Collaborator