Effects of Probiotic Supplementation on Gut Health, Immune Response, and Well-Being
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorOrthomol Pharmazeutische Vertiebs GmbH
About this trial
This randomized, double-blind, placebo-controlled exploratory study will evaluate the effects of daily probiotic supplementation on gut barrier function, immune-related markers, and well-being in healthy adults with mild to moderate perceived stress.
50 participants will be randomly assigned to receive either a probiotic supplement or placebo for 8 weeks. Blood and stool samples will be collected before and after the intervention to assess markers of gut barrier function, intestinal inflammation, gut microbiome composition, short-chain fatty acids, and immune function. Participants will also complete questionnaires on stress, quality of life, mood, digestive symptoms, and bowel habits. Safety will be evaluated throughout the study by monitoring adverse events and vital sign assessments.
Eligibility criteria
Qualifiers
Volunteer is healthy at the time of screening according to participant's own statements.
TICS SSCS score ≥ 6.
Male or female aged ≥18 and ≤65 years at the time of screening.
BMI ≥18.5 and ≤29.9 kg/m².
Disqualifiers
No command of local language.
Currently diagnosed neurological or psychiatric disorders.
Gastrointestinal disorders including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) or other conditions that might affect the gut environment.
Contraindication or allergy to any ingredient in the verum or Placebo product.
Trial design
Treatments tested in this trial
- Probiotic capsules
- Placebo
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Orthomol Pharmazeutische Vertiebs GmbH
Lead sponsor
Daacro GmbH & Co. KG, Max-Planck-Str. 22, 54296 Trier/Germany
Collaborator
Source ClinicalTrials.gov