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Poop pills could ease stomach troubles for scleroderma patients

NCT ID NCT06333795

Symptom relief Sponsor: University of Aarhus 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether fecal microbiota transplantation (FMT) – giving healthy donor stool in capsules – can safely reduce chronic diarrhea in people with systemic sclerosis. Twenty adults with scleroderma and persistent diarrhea will receive either FMT or a placebo. The main goal is to check for side effects, with a secondary look at whether symptoms improve.

What this could mean

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

Active substance
Fecal microbiota transplantation (FMT) given as capsules
What this could lead to
If it works, this could offer a new, safe way to manage chronic diarrhea in people with systemic sclerosis, improving daily comfort and quality of life.
What could go wrong
This is a very small, early pilot study with only 20 people. It mainly checks safety, not whether FMT truly works. Results may not apply to everyone with scleroderma.

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

20 people

The number who actually took part.

Started

Apr 2024

Expected to finish

Feb 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.

Ages

18 years and older

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: * Participants \> 18 years * Fulfilling and previously diagnosed with SSc according to the 2013 American College of Rheumatology/European League against rheumatisms SSs classification criteria\[23\] by rheumatologist or dermatologist. * Chronic diarrea is defined as loose or watery stools, three or more times a day, a minimum of 50% of the days within the last four weeks. Exclusion Criteria: * Inability to understand Danish spoken or written and/or Trial procedures. * Known or anticipated pregnancy (excluded by male sex, postmenopausal women, or otherwise negative U-HCG) * Previous treatment with FMT * Treatment with antibiotics within the past 6 weeks * Changes in morphine treatment within the past 4 weeks * Ongoing infection with Clostridioides difficile (negative PCR test) * Known serious gastrointestinal disease or GI infection (diagnosed with e.g. inflammatory bowel disease and/or gastrointestinal cancer) * Dysregulated thyroid disease (TSH) blood sample from previous consultations maximum 6 months old from * Known intestinal stricture * Planned MR scan within the study period * Pacemaker/ICD * Previous abdominal surgery (minor surgical procedures ex. appendectomy is allowed) * Changes in medicine that affect the GI tract within the past four weeks. * Known Severe end-organ disease * Lung disease with forced vital capacity(FVC)\<50% and/or diffusing lung capacity for carbon monoxide (DLCO) \<40% * Severe heart failure with ejection fraction \<30% * End-stage kidney disease with glomeration rate\<30ml/min

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Conditions

The condition(s) this trial relates to.

diarrheal disease systemic sclerosis

As listed by the trial registrant

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

Diarrhea Systemic sclerosis

Contacts and locations

Locations

  • Aarhus University Hospital

    Aarhus, Denmark

More trials for these conditions

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