The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Pa… (NCT06317441) | Clinical Trial Compass
RecruitingNot Applicable
The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
Canada105 participantsStarted 2024-07-20
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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).
✓. Participants with at least one of the following Rome IV diagnoses: FABD, functional diarrhea, IBS-M, or IBS-D.
✓. Baseline weekly average of worst daily (in past 24 hours) abdominal bloating/distension score of \>= 3.0 on a 0-to-10-point scale.
✓. Participants with abnormal LHBT following the North American Consensus recommendations (A rise in hydrogen of ≥20 ppm by 90 min).
Exclusion criteria
✕. 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.
What they're measuring
1
Change in bloating/distension severity
Timeframe: From baseline to end of intervention (week 8).
✕. History of known structural gastrointestinal abnormalities such as structures or fistulas leading to mechanical obstruction.
✕. Known history abdominal radiation treatment.
✕. Use of any medications in the week prior to the screening study visit, unless part of regular treatment, that could substantially alter gastrointestinal motor function (e.g., opioids, anticholinergics, or GLP-1 analogues); laxative use is allowed if used less than 3 times a week and it is willing to keep unchanged in the week prior to the SIMBA capsule ingestions. Proton pump inhibitors (PPIs) are allowed provided a wash-out period of 48 hours is respected before swallowing the SIMBA capsules and PPI treatment is resumed only 4 hours thereafter.
✕. Unable to stop using laxatives or prokinetic medications for 4 days before the study procedure (BT). Laxatives can be resumed after the test is conducted.