Could probiotics be the key to a healthier gut and a calmer mind?

NCT ID NCT07779265

Disease control Sponsor: Orthomol Pharmazeutische Vertiebs GmbH Source: ClinicalTrials.gov ↗

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This study tests whether taking a daily probiotic supplement for 8 weeks can improve gut barrier function, immune response, and overall well-being in healthy adults who feel mild to moderate stress. Half of the 50 participants will receive the probiotic, while the other half gets a placebo. Researchers will analyze blood and stool samples and use questionnaires to measure changes in gut health, stress, mood, and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Probiotic supplement containing fructooligosaccharides, selected probiotic strains, and vitamins
What this could lead to: If effective, this probiotic could offer a simple, daily way to support gut health and ease stress-related symptoms in healthy adults.
What could go wrong: This is a small exploratory study, so results may not be conclusive or apply broadly. Probiotics can cause mild digestive upset in some people.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * Volunteer is able and willing to comply with the study instructions. * Volunteer is suitable for participation in the study according to the investigator/study personnel. * Voluntary, written informed consent to participate in the study. Exclusion Criteria: * 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. * Use of drugs in the previous 4 weeks before the beginning of intervention. * Use of laxatives and labelled pre#and probiotics in the previous 2 weeks before the beginning of intervention. * Participation in another study with any investigational product within 30 days of screening, or less than five elimination half-lives after the last administration of the investigational product (whichever period is longer) or during the study. * History of drug (recreational) or alcohol abuse. * Bowel preparation for investigative procedures in the 4 weeks prior to screening. * Surgical resection of any part of the bowel (excl. appendectomy). * Pregnant or lactating female, or pregnancy planned during study period, or women of childbearing potential who are not using a medically approved form of contraception (at least three months prior to screening). * Regular smoking.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gut microbiome Immune responses Well being

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

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Could probiotics be the key to a healthier gut and a calmer mind?

What the study statuses mean