Fecal Microbiota Transplantation for Refractory IgA Nephropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-22

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Rituximab in Recurrent IgA Nephropathy

NCT02571842

Recurrent IgA Nephropathy

UNKNOWN PHASE4

Gut Microbiome Analysis in Organ Transplant Recipient

NCT06405958

Microbial Colonization

NOT_YET_RECRUITING

Iguratimod in Kidney Transplant Recipients

NCT02839941

Kidney Transplantation

UNKNOWN NA

Microbiome and Immunosuppression: The Mission Study

NCT04953715

Kidney Transplant Rejection Kidney Transplant

ACTIVE_NOT_RECRUITING

Study in Recipients of Renal Transplant Allograft to Evaluate the Impact of Two Immunosuppressive Regimens

NCT01653847

End Stage Renal Failure With Renal Transplant

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

IgA Nephropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FMT treatment

FMT treatment arm: Accept fecal microbiota transplantation without changing the ongoing treatment strategy.

Group Type EXPERIMENTAL

Fecal microbiota transplantation

Intervention Type BIOLOGICAL

Fecal donors are selected according to the predefined criteria. Fecal microbiota suspension is prepared by using fresh feces from the selected fecal donors. Then, administration of 200 ml fecal microbiota suspension through a transendoscopic enteral tubing or retention enema.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fecal microbiota transplantation

Fecal donors are selected according to the predefined criteria. Fecal microbiota suspension is prepared by using fresh feces from the selected fecal donors. Then, administration of 200 ml fecal microbiota suspension through a transendoscopic enteral tubing or retention enema.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No