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Enzyme pill tested to calm celiac gut symptoms

NCT ID NCT07831408

NEW Symptom relief Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing whether a dietary supplement called Galactol improves overall well-being and reduces gastrointestinal symptoms in adults with celiac disease who have functional abdominal bloating. The study enrolls 50 people aged 18 to 70. Participants take either Galactol or a placebo for 30 days, then researchers compare changes in well-being, abdominal pain, quality of life, and blood markers of inflammation.

What this could mean

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

Active substance
Galactol, a dietary supplement containing the enzymes alpha-galactosidase and beta-galactosidase
What this could lead to
If it works, this could offer a simple, over-the-counter enzyme supplement to ease bloating and improve daily well-being for people with celiac disease who still have gut symptoms on a gluten-free diet.
What could go wrong
This is a small, 30-day study of 50 people, so any benefit may be modest or fade, and the results may not apply to everyone with celiac disease. The supplement could cause digestive upset or allergic reactions in people sensitive to its ingredients.

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.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 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: * Patients who have provided written informed consent * Age: 18-70 years * Patients with celiac disease and functional abdominal bloating Exclusion Criteria: * Women who are pregnant or breastfeeding * Patients intolerant to one or more components of Galactol®/placebo * Patients allergic to one or more components of Galactol®/placebo

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Conditions

The condition(s) this trial relates to.

celiac disease

As listed by the trial registrant

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

Celiac disease

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

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