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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• 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).

Locations
Other Locations
Canada
Nimble Science
RECRUITING
Calgary
Contact Information
Primary
Gwen Duytschaever, PhD
clinical@nimblesci.com
8664934633
Backup
Isaac Wong, MBT
clinical@nimblesci.com
8664934633
Time Frame
Start Date: 2024-07-20
Estimated Completion Date: 2026-12
Participants
Target number of participants: 105
Treatments
Experimental: Probiotic (High dose)
A high dosage probiotic per capsule
Experimental: Probiotic (Low dose)
A low dosage probiotic per capsule
No_intervention: Control group (Placebo)
No probiotic dosage
Related Therapeutic Areas
Sponsors
Collaborators: Lallemand Health Solutions
Leads: Nimble Science Ltd.

This content was sourced from clinicaltrials.gov