Could a daily supplement soothe your gut and boost microbiome?

NCT ID NCT07453823

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a synbiotic supplement (a mix of probiotics and prebiotics) can improve gut health and reduce mild stomach discomfort in adults aged 50-70 who are overweight. Participants take the supplement or a placebo daily for 8 weeks, and researchers measure changes in gut bacteria and digestive symptoms. The goal is to see if this simple addition can help with issues like bloating or irregular bowel movements.

What this could mean

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

Active substance
synbiotic (probiotic and prebiotic supplement)
What this could lead to
If it works, this could point toward a simple supplement to ease mild gut issues and support gut health in middle-aged to elderly people with excess weight.
What could go wrong
This is a small, early-stage study with only 90 participants, so results may not apply to everyone. The supplement may not improve symptoms or gut function significantly.

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 90 people

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

Started

Mar 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

50 to 70 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: 1. Be able to give informed consent. 2. Be between 50 to 70 years of age (inclusive). 3. BMI ranging from 25.0 and 35.0 kg/m² 4. Willing to maintain current level of physical activity and diet during the participation in the study. 5. Experience ≤3 bowel movements per week within the month prior to screening 6. Participants reported subclinical mild to moderate gastrointestinal complaints as defined by GSRS-IBS score 20-45 at screening. 7. Willing to consume the study product daily for the duration of the study. 8. Willing to eat the same meal the evening before visiting site (visit 2 to visit 5). Participants are eligible for randomization if they fulfill the following two criteria based on the diary recordings during the run-in period prior to visit 2 9. Average GSRS-IBS composite symptom score between 20-45 during the two-week run-in period Record ≤6 bowel movements in the daily diary during the two-week run-in period Exclusion Criteria: 1. Has a history of drug and/or alcohol abuse. 2. Has food allergies, or other issues with foods, that would preclude intake of the study products. 3. Smoking, chewable tobacco and/or vaping and/or use of other nicotine products. 4. Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include: 1. diagnosis of GI disease (e.g. gastric or duodenal ulcers, inflammatory bowel disease, colon cancer) or irritable bowel syndrome (IBS) 2. GI surgery that might have an effect on gastrointestinal tract function except cholecystectomy and appendectomy in the past 5 years or any major bowel resection at any time. 3. history of CVD 4. uncontrolled hypertension 5. Currently or recently taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include: 1. systemic antimicrobial medication (including suppositories) within 4 weeks prior to visit 1 2. OTC medications, for digestive symptoms such as PPIs, anti-spasmodics, laxatives, anti-diarrheic drugs within 2 weeks prior to visit 1 10\. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study. 11\. Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results. c. immunosuppressant drugs within the 4 weeks prior to the visit 1 d. systemic steroids within the 4 weeks prior to the visit 1 6. Regular oral non-steroidal anti-inflammatory (NSAIDs) within 1 week prior to visit 1 (topical NSAIDS allowed, Low-dose prophylactic aspirin use is acceptable if stable for 3 months prior to screening.) 7. Current or recent (in the past 4 weeks prior to visit 1) use of prohibited nutritional and non-nutritional supplements, that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results, including: a. Herbal supplements for digestive symptoms b. Large doses of vitamins and minerals, unless in stable dose c. Probiotic supplements d. Iron supplements 8. Current or recent (in the past 2-weeks) use of prohibited foods including yoghurts containing probiotics. 9\. Planned major changes in lifestyle \[i.e., diet (e.g. start of fibre-enriched diet), dieting, exercise level, travelling\] during the duration of the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

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

  2. The official record

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

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atlantia Clinical Trials Ltd

    RECRUITING

    Cork, Blackpool, T23 R50R, Ireland

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