Determination of the Safety and Efficacy of Two Probiotic Strains

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe Archer-Daniels-Midland Company

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

100 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

The Archer-Daniels-Midland Company

Lead sponsor

Merieux NutriSciences (China)

Collaborator