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Hidden gut inflammation may drive familial mediterranean fever

NCT ID NCT06981520

Knowledge-focused Sponsor: Hitit University 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are studying whether the lining of the small intestine shows signs of inflammation in people with Familial Mediterranean Fever (FMF), a genetic condition that causes recurring fevers and pain. The study compares intestinal biopsy samples from about 30 adults with FMF to samples from healthy controls. Using tissue staining, the team measures levels of three inflammatory proteins: IL-1, IL-18, and Caspase-1. The goal is to understand whether gut immune activity plays a role in FMF and whether these proteins could become targets for future treatments.

What this could mean

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

What this could lead to
If researchers find higher levels of these inflammatory markers in the gut lining of people with FMF, that could point toward new drug targets for the disease.
What could go wrong
This small study only measures markers in tissue samples. It cannot prove that gut inflammation causes FMF symptoms, and the findings may not lead to a treatment.

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.

Participants

30 people

The number who actually took part.

Started

Jul 2025

Finished

May 2026

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.

Who is studied

This study includes adult patients diagnosed with Familial Mediterranean Fever (FMF) who underwent routine endoscopic evaluation with intestinal mucosal biopsies. A control group composed of age- and sex-matched individuals without inflammatory or autoimmune diseases was also included for comparative analysis. All participants were retrospectively selected based on availability of adequate tissue samples and relevant clinical data.

Ages

18 to 55 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:Age 18 years or older Confirmed diagnosis of Familial Mediterranean Fever (FMF) according to Tel-Hashomer clinical criteria and/or MEFV gene mutation analysis (for FMF group) Undergoing routine endoscopy with mucosal biopsy sampling Availability of sufficient formalin-fixed paraffin-embedded (FFPE) tissue for immunohistochemical analysis For controls: absence of systemic inflammatory or autoimmune disease - Exclusion Criteria:History of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) Current use of immunosuppressive therapy (excluding colchicine) Severe infection, active malignancy, or other systemic disease affecting intestinal mucosa Inadequate biopsy specimen quality for histopathological evaluation \-

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Conditions

The condition(s) this trial relates to.

familial Mediterranean fever Fever hereditary disease intestinal disorder

As listed by the trial registrant

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

Familial mediterranean fever Fever Genetic disease Intestinal disease

Contacts and locations

Locations

  • Hitit University Erol Olçok Training and Research Hospital

    Çorum, 19040, Turkey (Türkiye)

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