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Could a gut bacteria transplant help control type 1 diabetes?

NCT ID NCT06256614

Disease control Sponsor: The Second Hospital of Nanjing Medical University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study is testing whether transplanting gut bacteria from healthy donors into people with type 1 diabetes can help control blood sugar and reduce insulin needs. Fifty participants will receive three doses of washed microbiota through the gastrointestinal tract. Researchers will track daily insulin use and time spent in target blood sugar range to see if the treatment is safe and effective.

What this could mean

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

Active substance
washed microbiota from healthy donors
What this could lead to
If it works, this could offer a new way to help manage type 1 diabetes by improving blood sugar control and reducing the amount of insulin needed.
What could go wrong
This is a small, early real-world study with only 50 participants, so results may not apply to everyone. The treatment involves infusing donor bacteria into the gut, which carries unknown risks and may not provide lasting 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.

Participants

About 50 people

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

Started

Mar 2024

Expected to finish

Jul 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.

Who is studied

National patients with T1DM receiving WMT will be enrolled.

Ages

3 to 100 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: Subjects must meet all of the following inclusion criteria to enter the study: 1. At the time of informed consent, male or non-pregnant or non-lactating female. 2. The diagnostic criteria for T1DM are confirmed by previous medical record. 3. The subject or his/her legal representative gives informed consent, fully nderstands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study. Exclusion Criteria: Subjects meeting any of the following exclusion criteria must be excluded from the study: 1. Diagnosed as any type of diabetes other than type 1 diabetes mellitus; 2. Subjects with severe life-threatening complications diabetes (such as ketoacidosis, or acute coronary syndrome, etc.); 3. At the time of screening, the subject or his/her legal representative refuses to take effective contraception within 3 months after the last treatment. 4. According to the judgment of the investigator, the subjects are not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subjects.

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Conditions

The condition(s) this trial relates to.

hypoglycemia Insulin Resistance type 1 diabetes mellitus

As listed by the trial registrant

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

Type 1 diabetes

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

  • Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, 210011, China

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