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Prebiotic pill aimed to tame morning stress hormone – but trial never started

NCT ID NCT06566157

Symptom relief Sponsor: University of Southampton Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study planned to test whether taking a prebiotic supplement for six weeks could reduce morning cortisol levels in healthy young adults aged 18-25 with mild to moderate stress. Participants would have provided saliva, stool, urine, and blood samples. However, the trial was withdrawn before any volunteers were enrolled, so no results are available.

What this could mean

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

Active substance
Prebiotic supplement (WellBiome® - inulin, XOS, magnesium chloride)
What this could lead to
If it had worked, this could point toward a simple dietary supplement to help manage stress and improve wellbeing in young adults.
What could go wrong
The trial was withdrawn before enrolling anyone, so no data was collected. Even if run, the effect on cortisol is uncertain and may not translate to real-world stress relief.

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.

Expected to start

Jan 2025

An estimate. Start dates often move.

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 25 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: * Aged 18-25 at time of recruitment * Body Mass Index (18.5 - 29.9 kg) : Healthy - Overweight * Stress score of 15≤ - ≥25 (DASS) * Willing and with capacity to give informed consent to participate at time of recruitment * Speak and comprehend English to a good standard * In good general health * Willing to provide stool, urine and blood (8mL) sample during intervention * Willing to attend 4 visits to Southampton General Hospital Clinical Research Facility over 10-11 weeks Exclusion Criteria: * Consuming ≥ 14 units of alcohol/week (6 x 175 mL of wine, 6 pints of 4% beer) * Learning or behavioural difficulties (assessed on individual basis) * Planning a pregnancy in the next 6 months, pregnant, lactating or had a recent birth ≥6 months * Currently smoking or using e-cigarette, vape * Vulnerable adults (with self reported sever or very severe stress score (DASS) * Unwilling to suspend existing probiotic / prebiotic supplementation (with additional 4 weeks washout) before starting study. Medical exclusions: * Actively involved in therapy or psychiatric intervention of a diagnosed mental health condition * Prescribed psychotropic medication (Antidepressants, Monoamine Oxidase Inhibitors (MAOI's), Antipsychotics, sleeping pills, mood stabilisers etc) * Allergic to milk, soy, corn, penicillin or fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPS) * Currently prescribed laxatives, enemas, anti-coagulants or painkillers * Existing medical condition: cancer, hepatobiliary surgery, diabetes or diagnosed gastrointestinal diseases (irritable bowel disease, ulcerative colitis) * Involved in a recent pharmacology/psychological intervention, last 6 months * Recent antibiotic prescription, last 6 months

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Conditions

The condition(s) this trial relates to.

Psychological Well-Being

As listed by the trial registrant

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

Healthy Mental health Wellbeing

Contacts and locations

Locations

  • NIHR Southampton Clinical Research Facility

    Southampton, Hampshire, SO16 6YD, United Kingdom

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Other studies related to the condition(s) this trial covers.