Determination of the Safety and Efficacy of Two Probiotic Strains

Launched by THE ARCHER-DANIELS-MIDLAND COMPANY · Jun 17, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to find out if two specific probiotic strains can help adults feel better when they have mild to moderate gastrointestinal discomfort, which includes issues like bloating or abdominal pain. Over a total of 12 weeks, participants will take either the probiotic or a placebo (a harmless substance that looks like the probiotic but doesn't contain any active ingredients) for six weeks each, without knowing which one they are receiving at any time. Throughout the trial, participants will fill out a weekly questionnaire about their gut health and will also provide blood and stool samples at the start and end of the study to check for changes in gut health markers.

To participate, individuals need to be healthy adults aged 18 to 65 who have mild to moderate gastrointestinal complaints, as measured by a specific scoring system. However, those with serious medical conditions, recent surgeries, or who are pregnant or breastfeeding cannot join. The trial is not currently recruiting participants, but it aims to help researchers understand how effective and safe these probiotics might be for improving gut health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed Informed consent form
• • 2. Healthy adults aged 18-65 years
• • 3. Subclinical mild to moderate gastrointestinal complaints (GSRS-IBS score 20-45 at baseline)
• Exclusion Criteria:
• • 1. 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
• • 2. Severe chronic illnesses
• • 3. Known immunodeficiency
• • 4. Use of immunosuppressive agents (corticosteroids, methotrexate...)
• • 5. Presence of severe immunodeficient family members as provided by subjects self-report
• • 6. Pregnancy, 6 months postpartum period or current breastfeeding
• • 7. Women of childbearing age planning pregnancy during the course of the study
• • 8. 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
• • 9. Not able to understand and comply with requirements of the study
• • 10. Use of probiotics, prebiotics, postbiotics, antibiotics within 3 weeks of study commencement