Fecal Microbiota Transplantation for Type 2 Diabetes Mellitus and Hashimoto's Thyroiditis
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.
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
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Xu Jun Shen
- 전화번호: +8615906675015
- 이메일: sxjsandy@126.com
연구 연락처 백업
- 이름: Ling Ling Zhang
- 전화번호: +8619706851581
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Fecal microbiota transplantation group
|
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).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Glycated Hemoglobin(HbA1c)
기간: baseline，week 12，week 24
|
baseline，week 12，week 24
|
|
Fasting blood glucose
기간: baseline，week12，week24
|
baseline，week12，week24
|
|
2-hour postprandial blood glucose
기간: baseline，week12，week24
|
baseline，week12，week24
|
|
Thyroid Peroxidase Antibody(TPOAb)
기간: baseline，week12，week24
|
baseline，week12，week24
|
|
Thyroglobulin Antibody(TgAb)
기간: baseline，week12，week24
|
baseline，week12，week24
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Recovery of characteristic gut microbiota
기간: baseline，week 12，week 24
|
baseline，week 12，week 24
|
|
Triglycerides
기간: baseline，week12，week24
|
baseline，week12，week24
|
|
Total cholesterol
기간: baseline，week12，week24
|
baseline，week12，week24
|
|
Uric acid
기간: baseline，week12，week24
|
baseline，week12，week24
|
|
Fasting Insulin
기간: baseline，week12，week24
|
baseline，week12，week24
|
|
Body weight
기간: baseline，week12，week24
|
baseline，week12，week24
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Zhelvyi Ethics【2026】No.12
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
Only qualified clinical research investigators may submit formal written data access applications to the principal investigator.
Approved applicants can obtain de-identified individual participant data, study protocol, statistical analysis plan and informed consent form.
Data will be delivered via encrypted electronic files after signing a data use agreement.
Data application requests shall be submitted by email to the principal investigator; there is no dedicated public web portal for online application.
All data access inquiries and completed application documents should be sent to the principal investigator via official email.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .