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Could a Dual-Action supplement tame irritable bowel syndrome?

NCT ID NCT07716852

Disease control Sponsor: Gala Servicios Clinicos S.L. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This study tests whether a daily supplement called Enzymax DuoBiotics can ease symptoms of irritable bowel syndrome (IBS) in adults. The supplement combines digestive enzymes that break down food in the stomach with a probiotic and prebiotic that support gut bacteria in the intestines. Over 12 weeks, researchers will measure changes in symptom severity and quality of life in 120 participants, comparing the supplement to a placebo.

What this could mean

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

Active substance
a dietary supplement containing digestive enzymes (lipase, protease, amylase, glucoamylase) and a probiotic (Lactobacillus plantarum) with prebiotic fiber (fructooligosaccharides)
What this could lead to
If it works, this supplement could offer a new option for managing IBS symptoms like bloating, pain, and irregular bowel habits.
What could go wrong
This is a small, early-stage trial with 120 people, and supplements often show limited benefit over placebo. Results may not apply to all IBS types.

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 120 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

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 70 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: * Adults aged 18 to 70 years * Diagnosis of irritable bowel syndrome according to the Rome IV criteria. * Presence of active irritable bowel syndrome symptoms at the time of enrollment. * Ability and willingness to provide written informed consent. * Ability and willingness to comply with the study procedures and the 12-week treatment period. Exclusion Criteria: * Presence of an organic gastrointestinal disease. * Use of antibiotics or probiotics within 1 month before enrollment. * Recent clinically relevant changes in diet. * Severe comorbid medical conditions. * Inability or unwillingness to comply with the study protocol. * Known hypersensitivity to any component of Enzymax DuoBiotics or to dietary supplements of similar composition. * Any other condition that, in the investigator's judgment, may interfere with participation, study treatment, or interpretation of the results.

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Conditions

The condition(s) this trial relates to.

irritable bowel syndrome

As listed by the trial registrant

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

Irritable bowel syndrome Irritable bowel syndrome (IBS)

How to take part

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

  1. 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 ↗

  2. 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.

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