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Scientists probe gut bacteria after fecal transplants to unlock secrets of chronic disease

NCT ID NCT06992453

Knowledge-focused Sponsor: Catholic University of the Sacred Heart 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will give fecal transplants to 90 people with recurrent C. difficile infection, ulcerative colitis, or metabolic syndrome. Researchers will use advanced tests on stool and tissue samples to track how donor bacteria settle in the gut and interact with the host. The goal is to understand why fecal transplants work well for some conditions but not others, which could improve future treatments.

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)
What this could lead to
If successful, this could reveal why fecal transplants work for some conditions but not others, potentially leading to more effective treatments for gut-related diseases.
What could go wrong
This is an early-stage observational study, not a treatment trial. It aims to understand mechanisms, not to test a cure. Results may not lead to direct patient benefits.

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 90 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Feb 2029

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: Coorte: Patients affected by Ulcerative Colitis * Age ≥18 years. * UC with mild-to-moderate activity (total Mayo score 3-10 + endoscopic subscore≥1) (23) * UC during stable maintenance therapy (\> 8 weeks with salicylates, immunosuppressants); * Ability to give informed consent. Coorte: Patients affected by metabolic syndrome * Age ≥18 years. * Patients with MetS (high glycaemia levels (\> 100 mg/dL), hypertension (\> 130/85 mmHg), raised triglyceride levels (\> 150 mg/dL), low high-density lipoprotein cholesterol levels (\< 40 mg/dL in men; \<50 mg/dL in women), and abdominal obesity (waist circumference of \> 102 cm in men; \>88 cm in women) * Stable treatment (\> 8 weeks) of one of these disorders, included in MetS definition. * Ability to give informed consent Coorte: Patients affected by rCDI * Age ≥18 years * Mild recurrent Clostridioides difficile infection (26) * Ability to give informed consent. Exclusion criteria * Pregnancy, breastfeeding, and the refusal to follow an effective contraception method for all the study duration (for women). * Known active gastrointestinal disorders (e.g. infectious gastroenteritis except CDI, coeliac disease, irritable bowel syndrome, chronic pancreatitis, biliary salt diarrhoea) apart from UC, with clinical characteristics reports in inclusion criteria. * Antimicrobial treatment up to 4 weeks prior to screening visit (apart for patients with rCDI) * Previous colorectal surgery or cutaneous stoma * Critical and severe comorbidities * Inability to give informed consent.

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome Clostridium difficile colitis metabolic syndrome X ulcerative colitis

As listed by the trial registrant

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

Metabolic syndrome (METS) Recurrent C. difficile (RCDI) Ulcerative colitis (UC)

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

  • Catholic University of the Sacred Heart

    Rome, RM, 00168, Italy

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