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Could ditching gluten ease two tough gut diseases?

NCT ID NCT06026449

Disease control Sponsor: Institute for Clinical and Experimental Medicine 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether a gluten-free diet can help people with primary sclerosing cholangitis (PSC) and inflammatory bowel disease (IBD). Researchers will track changes in symptoms, gut bacteria, and lab results in 60 adults over time. The goal is to see if avoiding gluten can slow disease progression and improve quality of life.

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 60 people

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

Started

Jan 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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 (for PSC group): * Established diagnosis of PSC (based on radiologic features, typical finding on MRCP or ERCP) * Age 18 - 65 years * ALP 1,5x higher than ULN * Signed informed consent Exclusion Criteria (for PSC group): * Patients on gluten-free diet * Patients with coeliac disease or wheat allergy * Liver transplant recipients * PSC/AIH overlap syndrome * Other causes of liver disease * Radiologic or clinical signs of decompensated liver cirrhosis * Advanced liver cirrhosis (MELD score ˃ 15) * Recurrent acute cholangitis or cholangiogenic sepsis in past 3 months * Use of antibiotics in past 3 months * History of malignancy * Pregnant women * Not signed informed consent Inclusion criteria (for UC group): * Ulcerative colitis diagnosed based on clinical, endoscopic and histological findings * Extension of affected colon \> 15cm * Mayo score 0-4 * Signed informed consent Exclusion criteria (for UC group): * CMV, Clostridium difficile enterocolitis in past 3 months * Use of antibiotics in past 3 months * Patients with coeliac disease or wheat allergy * Patients on gluten-free diet * Pregnant women * Not signed informed consent * Biologic therapy * Methotrexate * Prednison \> 10 mg * Not signed informed consent

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Conditions

The condition(s) this trial relates to.

biliary tract disorder cholangitis Cholangitis, Sclerosing intestinal disorder primary sclerosing cholangitis ulcerative colitis

As listed by the trial registrant

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

Biliary disease tract Biliary tract diseases Intestinal disease Primary sclerosing cholangitis Ulcerative colitis

Contacts and locations

Locations

  • Institute of clinical and experimental medicine

    Prague, Prague, 14021, Czechia

More trials for these conditions

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