Autoimmune Thyroid DiseasePhase 4NCT07733232
Fecal Microbiota Transplantation for Type 2 Diabetes Mellitus and Hashimoto's Thyroiditis
A Phase 4 study testing Fecal microbiota transplantation oral capsules in people with Autoimmune Thyroid Disease and Type 2 Diabetes Mellitus (T2DM), run by Shen Xujun.
Trial summary
The goal of this clinical trial is to learn if fecal microbiota transplantation (FMT) can improve metabolic control and immune function in adults with both type 2 diabetes and Hashimoto's thyroiditis (an autoimmune thyroid disease). It will also learn about the safety of FMT in these patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autoimmune Thyroid Disease, Type 2 Diabetes Mellitus (T2DM), FMT
- What is being tested?
- Fecal microbiota transplantation oral capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 65 years old.
- Diagnosed with type 2 diabetes mellitus (T2DM).
- Positive for thyroid peroxidase antibody (TPOAb) and thyroglobulin antibody (TgAb); thyroid ultrasonography indicates diffuse thyroid lesions.
- 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.
Who cannot join
- Subjects who have used antibiotics, probiotics or prebiotics within 4 weeks prior to screening.
- Patients complicated with severe gastrointestinal diseases (e.g., inflammatory bowel disease, active gastrointestinal bleeding).
- Patients receiving specialized treatment for hyperthyroidism (Graves' disease) or with a history of thyroid malignancy.
- Patients with severe immunosuppression (neutrophil count < 1500/mm³, lymphocyte count < 500/mm³).
- Patients with active severe gastrointestinal bleeding, intestinal perforation, or severe intestinal barrier/mucosal injury.
- Patients with intestinal mucosal injury of unknown etiology.
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- Patients diagnosed with fulminant colitis or toxic megacolon.
- Patients with active extraintestinal infection requiring treatment with broad-spectrum antibiotics.
- Severe malnutrition (body mass index < 15 kg/m²) or severe hypoalbuminemia (serum albumin < 25 g/L).
- Congenital or acquired immunodeficiency diseases.
- 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).
- Patients complicated with other autoimmune diseases.
- Patients with severe hepatic or renal insufficiency.
- Patients with malignant tumors.
- Patients with known allergy to capsule ingredients.
- Pregnant or lactating females.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ling Ling Zhang contact
About this study
Official title: Efficacy of Fecal Microbiota Transplantation in Improving Metabolic Parameters and Immune Dysregulation in Patients With Concurrent Type 2 Diabetes Mellitus and Autoimmune Thyroid Disease.
The goal of this clinical trial is to learn if fecal microbiota transplantation (FMT) can improve metabolic control and immune function in adults with both type 2 diabetes and Hashimoto's thyroiditis (an autoimmune thyroid disease). It will also learn about the safety of FMT in these patients. The main questions it aims to answer are:
Can FMT lower blood sugar levels (HbA1c, fasting blood glucose, and 2-hour post-meal blood glucose) in participants with type 2 diabetes? Can FMT reduce thyroid autoantibody levels (TPOAb and TgAb) in participants with Hashimoto's thyroiditis? This is a single-arm study, meaning all participants will receive the same FMT treatment. Researchers will compare each participant's results before and after the intervention to see if FMT has an effect.
Read more
Participants will:
Complete baseline tests including blood work and stool sample collection during the 2-week screening period Take 40 oral FMT capsules by mouth over about 1.5 hours under medical supervision at the start of the study Keep taking their usual diabetes and thyroid medications at the same dose throughout the study, unless their doctor says otherwise Return for follow-up visits and tests at 12 weeks and 24 weeks after the FMT treatment
- Being tested
- Fecal microbiota transplantation oral capsules
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantation oral capsulesBiological
All subjects received a single standardized fecal microbiota transplantation (FMT) intervention at Week 0 under unified protocols. After fasting, each subject took 40 standardized fecal microbiota suspension capsules in divided doses within 1.5 hours (2-3 capsules each time, swallowed with warm water).
| Study group | Role | What they receive |
|---|---|---|
| Fecal microbiota transplantation group | Experimental | Not described Receives: Biological: Fecal microbiota transplantation oral capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated Hemoglobin(HbA1c)
Measured: baseline，week 12，week 24
Fasting blood glucose
Measured: baseline，week12，week24
2-hour postprandial blood glucose
Measured: baseline，week12，week24
Thyroid Peroxidase Antibody(TPOAb)
Measured: baseline，week12，week24
Thyroglobulin Antibody(TgAb)
Measured: baseline，week12，week24
Secondary outcomes (6)
Recovery of characteristic gut microbiota
Measured: baseline，week 12，week 24
Triglycerides
Measured: baseline，week12，week24
Total cholesterol
Measured: baseline，week12，week24
Uric acid
Measured: baseline，week12，week24
Fasting Insulin
Measured: baseline，week12，week24
Body weight
Measured: baseline，week12，week24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Thyroid DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shen Xujun
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Shen Xujun, Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733232
- Sponsor's protocol ID
- Zhelvyi Ethics【2026】No.12
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The shared individual participant data include baseline demographic data, laboratory indicators, primary and secondary outcome measures collected at Week 12 and Week 24, adverse event records. Raw data will be de-identified to remove all personal identifiable information before sharing.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fecal Microbiota Transplantation in Improving Metabolic Parameters and Immune Dysregulation in Patients With Concurrent Type 2 Diabetes Mellitus and Autoimmune Thyroid Disease.
- ClinicalTrials.gov ID
- NCT07733232
- Acronym / sponsor ID
- Zhelvyi Ethics【2026】No.12
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Shen XujunOther government
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if fecal microbiota transplantation (FMT) can improve metabolic control and immune function in adults with both type 2 diabetes and Hashimoto's thyroiditis (an autoimmune thyroid disease). It will also learn about the safety of FMT in these patients. The main questions it aims to answer are:
Can FMT lower blood sugar levels (HbA1c, fasting blood glucose, and 2-hour post-meal blood glucose) in participants with type 2 diabetes? Can FMT reduce thyroid autoantibody levels (TPOAb and TgAb) in participants with Hashimoto's thyroiditis? This is a single-arm study, meaning all participants will receive the same FMT treatment. Researchers will compare each participant's results before and after the intervention to see if FMT has an effect.
Participants will:
Complete baseline tests including blood work and stool sample collection during the 2-week screening period Take 40 oral FMT capsules by mouth over about 1.5 hours under medical supervision at the start of the study Keep taking their usual diabetes and thyroid medications at the same dose throughout the study, unless their doctor says otherwise Return for follow-up visits and tests at 12 weeks and 24 weeks after the FMT treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fecal microbiota transplantation group | Experimental | Biological: Fecal microbiota transplantation oral capsules |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 and ≤ 65 years old.
- Diagnosed with type 2 diabetes mellitus (T2DM).
- Positive for thyroid peroxidase antibody (TPOAb) and thyroglobulin antibody (TgAb); thyroid ultrasonography indicates diffuse thyroid lesions.
- 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.
Key exclusion criteria (16 listed)
- Subjects who have used antibiotics, probiotics or prebiotics within 4 weeks prior to screening.
- Patients complicated with severe gastrointestinal diseases (e.g., inflammatory bowel disease, active gastrointestinal bleeding).
- Patients receiving specialized treatment for hyperthyroidism (Graves' disease) or with a history of thyroid malignancy.
- Patients with severe immunosuppression (neutrophil count < 1500/mm³, lymphocyte count < 500/mm³).
- Patients with active severe gastrointestinal bleeding, intestinal perforation, or severe intestinal barrier/mucosal injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal microbiota transplantation oral capsulesAll subjects received a single standardized fecal microbiota transplantation (FMT) intervention at Week 0 under unified protocols. After fasting, each subject took 40 standardized fecal microbiota suspension capsules in divided doses within 1.5 hours (2-3 capsules each time, swallowed with warm water). | Biological | Fecal microbiota transplantation group |
Primary outcome
Glycated Hemoglobin(HbA1c)
Time frame: baseline，week 12，week 24
Fasting blood glucose
Time frame: baseline，week12，week24
2-hour postprandial blood glucose
Time frame: baseline，week12，week24
Thyroid Peroxidase Antibody(TPOAb)
Time frame: baseline，week12，week24
Thyroglobulin Antibody(TgAb)
Time frame: baseline，week12，week24
6 secondary outcomes
Recovery of characteristic gut microbiota
Time frame: baseline，week 12，week 24
Triglycerides
Time frame: baseline，week12，week24
Total cholesterol
Time frame: baseline，week12，week24
Uric acid
Time frame: baseline，week12，week24
Fasting Insulin
Time frame: baseline，week12，week24
Body weight
Time frame: baseline，week12，week24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Yes. The shared individual participant data include baseline demographic data, laboratory indicators, primary and secondary outcome measures collected at Week 12 and Week 24, adverse event records. Raw data will be de-identified to remove all personal identifiable information before sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ling Ling Zhang contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fecal microbiota transplantation oral capsules in people with Autoimmune Thyroid Disease and Type 2 Diabetes Mellitus (T2DM), run by Shen Xujun.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xu Jun Shen (+8615906675015, sxjsandy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated Hemoglobin(HbA1c) (time frame: baseline，week 12，week 24). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.