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Gut bacteria clues could unlock scleroderma mysteries

NCT ID NCT04132206

Knowledge-focused Sponsor: Hôpital Européen Marseille Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 gut bacteria in people with systemic sclerosis (a chronic autoimmune disease) and compares them to healthy volunteers. Researchers will collect stool samples from 60 patients over 7 months and one sample from healthy controls. The goal is to understand how gut bacteria change over time and find clues that could lead to better diagnosis or treatments.

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

About 60 people

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

Started

Oct 2019

Expected to finish

Jun 2026

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.

Who is studied

Patients with ScS according to ACR criteria,and healthy volunteers without diagnosis of ScS or any other chronic disease

Ages

18 years and older

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: For ScS patients: 1. Patients with ScS according to ACR criteria. 2. Patients over 18 years old. 3. Patients who have signed the consent to participate in this study. For control subjects: 1. Persons without diagnosis of ScS or any other chronic disease. 2. Persons over 18 years old. 3. Persons who have signed the consent to participate in this study Exclusion Criteria: * 1\. Persons with severe anemia (Hb \< 7 g/dL). 2. Persons who cannot read French. 3. For control subjects: Persons with a particular symptom (as an example of digestive disorders), or under long-term treatment related to another pathology. 4\. Persons treated with antibiotics, probiotics, prebiotics or any other treatment that may disrupt the gut microbiota within two months before stool sampling. 5\. Persons referred to the article L1121-5 to 1121-8 of the Public health code, namely : * Pregnant, women in labour and breastfeeding mothers. * Persons deprived of their liberty by a judicial or administrative decision. * Persons undergoing psychiatric follow-up. * Minors * Persons of full-age who are subject to a legal protection measure or who are unable to express their consent.

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Conditions

The condition(s) this trial relates to.

systemic sclerosis

As listed by the trial registrant

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

Systemic sclerosis

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Hôpital Européen Marseille

    RECRUITING

    Marseille, 13003, France

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