About this trial
The goal of this study is to determine the safety and efficacy of two probiotic strains in adults with mild to moderate gastrointestinal discomfort. The main questions it aims to answer is whether 6-week administration of a probiotic can improve how the participant feels regarding their gut health. This is done by completing a weekly questionnaire and the results are compared between the 6 weeks the participants are on a placebo and the 6 weeks the participants are on the probiotic. Participants will also provide a blood sample, and stool sample at the start and end of each treatment. Similarly, the results from the blood samples and stool samples will be analysed to determine if there is any improvement in markers related to gut health.
Eligibility criteria
Qualifiers
Signed Informed consent form
Healthy adults aged 18-65 years
Subclinical mild to moderate gastrointestinal complaints (GSRS-IBS score 20-45 at baseline)
Disqualifiers
Presence of a serious congenital anomaly or chronic medical condition that would contraindicate participation, including history of major gastrointestinal surgery, chronic gastrointestinal illness, abnormal intestinal anatomy or significant abdominal disorder
Severe chronic illnesses
Known immunodeficiency
Use of immunosuppressive agents (corticosteroids, methotrexate…)
Trial design
Treatments tested in this trial
- Placebo 1 to Probiotic A
- Probiotic A to Placebo 1
- Placebo 2 to Probiotic B
- Probiotic B to Placebo 2
Treatment groups
Locations
Sponsors and collaborators
The Archer-Daniels-Midland Company
Lead sponsor
Merieux NutriSciences (China)
Collaborator