Actively Recruiting
The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
Led by Nimble Science Ltd. · Updated on 2025-04-29
105
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Nimble Science Ltd.
Lead Sponsor
L
Lallemand Health Solutions
Collaborating Sponsor
AI-Summary
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 probiotic's 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.
CONDITIONS
Brief Title
The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 �3e= 3.0 on a 0-to-10-point scale.
- Participants with abnormal lactulose hydrogen breath test following the North American Consensus recommendations (A rise in hydrogen of �3e=20 ppm by 90 min).
You will not qualify if you...
- History of less than three (3) bowel movements per week.
- Diagnosis of IBS with constipation (IBS-C).
- Prior gastrointestinal disease, surgery, or abdominal or pelvic radiation that could cause intestinal blockage or risk capsule non-excretion; appendectomy or cholecystectomy more than 3 months earlier allowed.
- Presence of central venous catheters.
- Known structural gastrointestinal abnormalities causing mechanical obstruction.
- History of abdominal radiation treatment.
- Use of medications that significantly alter gastrointestinal motor function within one week before screening, except regular treatments; limited laxative use allowed.
- Unable to stop using laxatives or prokinetic medications for 4 days before study test.
- Organic motility disorders such as gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome.
- Celiac disease (treated or untreated).
- Significant diseases affecting heart, liver, lung, kidney, blood, endocrine or nervous systems that could impact safety or outcomes.
- Cancer diagnosis or treatment within past year, except non-melanoma skin cancers.
- Gastrointestinal inflammatory diseases including ulcerative colitis, Crohn's disease, microscopic colitis.
- IBS with alarm symptoms like rectal bleeding, unexplained weight loss, iron deficiency anemia, or nocturnal symptoms.
- Participants over 50 without recent colon cancer screening or colonoscopy.
- Epilepsy diagnosis.
- Immunological, infectious, or immune-compromised conditions that could affect safety or outcomes.
- History of swallowing disorders increasing capsule aspiration risk.
- Antibiotic use (except topical) within 12 weeks prior to screening.
- Regular use of probiotics, prebiotics, or synbiotics within 1 month prior to screening.
- Any prior Fecal Microbiota Transplantation.
- Pregnant, breastfeeding, or planning pregnancy.
- Alcohol or drug abuse.
- Allergy to components in probiotic or placebo capsules.
- Non-English speaking.
- Scheduled for MRI during study period.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants take either a high dose probiotic, a low dose probiotic, or a placebo daily for 8 weeks to evaluate effects on gastrointestinal symptoms and microbiota.
Visits at baseline, mid-intervention (week 4), and end of intervention (week 8)
Duration - Up to 4 weeks after treatment
Participants are monitored for changes in symptoms, microbiota, and SIBO status after treatment ends.
1 visit at follow-up (week 12)
Trial Site Locations
Total: 1 location
1
Nimble Science
Calgary, Alberta, Canada, T2L 1Y8
Actively Recruiting
Research Team
G
Gwen Duytschaever, PhD
I
Isaac Wong, MBT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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