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Gut bacteria swap may tame diabetes and thyroid disease

NCT ID NCT07733232

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This trial tests whether a one-time dose of fecal microbiota transplantation (FMT) — taking capsules containing processed donor stool — can improve blood sugar control and reduce thyroid antibodies in adults who have both type 2 diabetes and Hashimoto's thyroiditis. All 38 participants will receive the same FMT treatment and be followed for 24 weeks. The study asks whether restoring gut bacteria can help manage these two conditions at once.

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) oral capsules
What this could lead to
If it works, this could point toward a new way to manage both blood sugar and autoimmune thyroid disease by restoring gut bacteria.
What could go wrong
This is a small, single-arm trial with no placebo group, so results may be due to chance. FMT can also carry risks like infection or digestive upset.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 38 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 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: 1. Age ≥ 18 and ≤ 65 years old. 2. Diagnosed with type 2 diabetes mellitus (T2DM). 3. Positive for thyroid peroxidase antibody (TPOAb) and thyroglobulin antibody (TgAb); thyroid ultrasonography indicates diffuse thyroid lesions. 4. The regimens of hypoglycemic drugs and thyroid-related basic treatments (including drug types and dosages) have remained stable for at least 3 months before enrollment. Exclusion Criteria: 1. Subjects who have used antibiotics, probiotics or prebiotics within 4 weeks prior to screening. 2. Patients complicated with severe gastrointestinal diseases (e.g., inflammatory bowel disease, active gastrointestinal bleeding). 3. Patients receiving specialized treatment for hyperthyroidism (Graves' disease) or with a history of thyroid malignancy. 4. Patients with severe immunosuppression (neutrophil count \< 1500/mm³, lymphocyte count \< 500/mm³). 5. Patients with active severe gastrointestinal bleeding, intestinal perforation, or severe intestinal barrier/mucosal injury. 6. Patients with intestinal mucosal injury of unknown etiology. 7. Patients diagnosed with fulminant colitis or toxic megacolon. 8. Patients with active extraintestinal infection requiring treatment with broad-spectrum antibiotics. 9. Severe malnutrition (body mass index \< 15 kg/m²) or severe hypoalbuminemia (serum albumin \< 25 g/L). 10. Congenital or acquired immunodeficiency diseases. 11. Patients who have recently received high-risk immunosuppressants or cytotoxic drugs (e.g., rituximab, doxorubicin), or medium-to-high dose glucocorticoids (e.g., prednisone \>= 20 mg per day for more than 4 consecutive weeks). 12. Patients complicated with other autoimmune diseases. 13. Patients with severe hepatic or renal insufficiency. 14. Patients with malignant tumors. 15. Patients with known allergy to capsule ingredients. 16. Pregnant or lactating females.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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