Determination of the Safety and Efficacy of Two Probiotic Strains (NCT06466174) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Determination of the Safety and Efficacy of Two Probiotic Strains
100 participantsStarted 2024-06
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Signed Informed consent form
✓. Healthy adults aged 18-65 years
✓. Subclinical mild to moderate gastrointestinal complaints (GSRS-IBS score 20-45 at baseline)
Exclusion criteria
✕. 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…)
✕. Presence of severe immunodeficient family members as provided by subjects self-report
✕. Pregnancy, 6 months postpartum period or current breastfeeding
. Women of childbearing age planning pregnancy during the course of the study
✕. Actively participating in another clinical study, having completed a clinical study in the past 60 days or being in the exclusion period of a previous clinical study