Fecal Microbiota Transplantation for Refractory IgA Nephropathy
- Conditions
- IgA Nephropathy
- Interventions
- Biological: Fecal microbiota transplantation
- Registration Number
- NCT03633864
- Lead Sponsor
- Air Force Military Medical University, China
- Brief Summary
IgA nephropathy (IgAN) is one of the most common glomerular diseases worldwide. Current treatments for IgAN are limited by their relatively insufficient efficacy and severe adverse events. Previous studies suggested that the disorder of intestinal flora may play an important role in the pathogenesis and prognosis of IgAN. Fecal microbiota transplantation (FMT) have been proved to be effective on rebuilding the intestinal microecological balance. However, there is no evidence for the safety and efficacy of FMT in IgAN. Therefore, investigators perform a prospective cohort study to evaluate the safety and efficacy of FMT in IgAN patients who did not response to the conventional treatment and did not want to aggravate immunosuppressive treatments or IgAN patients who did not response to immunosuppressive treatments.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Adult, age: 18-65 years old.
- Pathological diagnosis with IgAN, eGFR：20-120 mL/min/1.73 m2.
- The 24-hour urinary protein was still greater than 1g after 3-6 months of treatment of ACEI/ARB
- Recurrence of IgAN after glucocorticoid and (or)immunosuppressant decrement and the 24-hour urinary protein was greater than 1g.
- Not suitable for the administration of glucocorticoid and (or) immunosuppressive agents because of side effects.
- Women of child-bearing age with negative urine pregnancy test have no pregnancy plan for the next 18 months and take effective contraceptive measures.
- Agree to participate in this clinical trial
- Malignant tumors and other diseases with expected survival time <3 months.
- Severe cardiovascular and cerebrovascular diseases and pulmonary dysfunction.
- Other immune system diseases.
- Diabetes
- Inflammatory bowel disease（IBD）
- Clostridium difficile infection
- Gastrointestinal tumor
- Active gastrointestinal bleeding
- Acute and chronic gastroenteritis
- Have received or are receiving FMT treatment.
- HIV
- Psychosis AND dysgnosia
- Contraindication of colonoscopy and enema
- Alcohol/drug abuse
- Other conditions that the researchers thought were not appropriate for the group.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FMT treatment Fecal microbiota transplantation FMT treatment arm: Accept fecal microbiota transplantation without changing the ongoing treatment strategy.
- Primary Outcome Measures
Name Time Method Change of Urinary protein one time per week up to 8 weeks 24 hours urinary protein quantity
- Secondary Outcome Measures
Name Time Method Change of Serum creatinine one time per week up to 8 weeks Concentration of serum creatinine
Change of eGFR one time per week up to 8 weeks eGFR
Change of Hematuria one time per week up to 8 weeks Hematuria
Change of Blood pressure one time per week up to 8 weeks Blood pressure
Change of Serum IgA1 one time per week up to 8 weeks Serum IgA1
Change of Fecal microbiota one time per week up to 8 weeks Fecal microbiota
Adverse events associated with FMT one time per week up to 8 weeks Adverse events associated with FMT
Trial Locations
- Locations (1)
Xijing Hospital of Nephrology
🇨🇳Xi'an, Shaanxi, China