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Can probiotics soothe IBS in obesity? new study investigates

NCT ID NCT04760353

Symptom relief Sponsor: University Hospital Rijeka 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether a daily probiotic powder could relieve irritable bowel syndrome (IBS) symptoms in 80 obese adults. Participants took either the probiotic or a placebo for 8 weeks. Researchers tracked symptom relief and changes in gut bacteria.

What this could mean

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

Active substance
Probiotic mixture (OMNi-BiOTiC STRESS) containing 9 bacterial strains and B vitamins
What this could lead to
If it works, this could point toward a simple probiotic supplement to ease IBS symptoms in people with obesity.
What could go wrong
This is a small, completed trial with only 80 participants. The results may not apply to everyone, and probiotics don't work for all.

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

80 people

The number who actually took part.

Started

Nov 2021

Finished

Oct 2025

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 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Obese \[Body mass index (BMI) ≥30\] men or women with confirmed IBS (all subtypes based on Rome IV Diagnostic Criteria for IBS) aged between 18 and 65 years. * Written informed consent. Exclusion Criteria: * Pregnancy or lactation * Severe systemic illness \[cancer, gastrointestinal illness (e.g., colitis, Crohn's disease, celiac disease, recurrent diverticulitis), chronic renal failure, an endocrine disorder, metabolic disorder, angina, congestive heart failure, uncontrolled hypertension\] or severely impaired general health * Organic abnormality which is excluded by full blood count, C-reactive protein or erythrocyte sedimentation rate, and thyroid-stimulating hormone for constipated IBS participants. To exclude other organic lower gastrointestinal disease faecal calprotectin will be checked, and celiac test and colonoscopy will be performed if needed. * Previous abdominal surgery except for appendectomy, cholecystectomy and abdominal wall hernia repair * History of psychiatric disorder * History of participation in another clinical trial within 3 months before the onset of this trial * Medications that could affect the outcomes: oral steroid, sulfasalazine, cholestyramine, misoprostol and probiotics usage 3 months prior to and during the study; and antacids with magnesium or aluminium usage during the study

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Conditions

The condition(s) this trial relates to.

irritable bowel syndrome Obesity obesity disorder

As listed by the trial registrant

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

IBS - irritable bowel syndrome Obesity

Contacts and locations

Locations

  • Clinical Hospital Centre

    Rijeka, Croatia, 51000, Croatia

  • University Hospital Rijeka

    Rijeka, Rijeka, 51000, Croatia

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