Health TrialsbyHealthPanel

Effects of Probiotic Supplementation on Gut Health, Immune Response, and Well-Being

ConditionsGut MicrobiomeImmune ResponsesWell-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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Probiotic capsules

    Dietary supplement

    Fructooligosaccharides, selected probiotic strains, vitamins

  • Placebo

    Other intervention

    Maltodextrin, corn starch

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Probiotic SupplementExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Gut barrier function

Gut barrier function

Time frame
During 8 week intake phase
2

Immune function

Immune function

Time frame
During 8 week intake phase
3

Well-being

Perceived (health-related) quality of life, stress, anxiety, depression

Time frame
During 8 weeks intervention phase

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Orthomol Pharmazeutische Vertiebs GmbH

Lead sponsor

Daacro GmbH & Co. KG, Max-Planck-Str. 22, 54296 Trier/Germany

Collaborator

Source ClinicalTrials.gov
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