Gut bacteria swap may tame diabetes and thyroid disease
NCT ID NCT07733232
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 38 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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