Study on the Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Steroid - Dependent /Steroid-resistant Nephrotic Syndrome in Children
June 3, 2025 updated by: Zhang Ting
The objective of this clinical trial was to understand whether FMT is effective in treating steroid-dependent/steroid-resistant nephrotic syndrome in children.
It will also learn about the safety of FMT.
The main question it was designed to answer was: Did FMT reduce participants '24-hour urine protein content?
What medical problems did participants experience while using FMT?
The researchers will compare FMT treatment with and without FMT on top of conventional treatment to see if FMT is effective in treating steroid-dependent/steroid-resistant nephrotic syndrome in children.
Participants will receive 2 FMT treatments, 1 endoscopic injection under anesthesia, 1 oral fecal bacteria transplantation capsule intake, and follow-up visits (weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48) every 4 weeks from the beginning of medication to our renal specialist clinic for drug efficacy evaluation and safety testing.
Blood and fecal samples were collected to determine the effects of fecal bacterial transplantation on intestinal flora, fecal metabolomics, and intestinal mucosal permeability.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
120
Phase
- Early Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 2-18 years, steroid-dependent/steroid-resistant nephrotic syndrome, regardless of gender, with SDNS at steroid-dependent doses less than 0.5 mg/kg.d
Exclusion Criteria:
- Those with concurrent infections or diseases of other organ systems, and those with abnormal renal function.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: SDNS:control group
Traditional treatment plan: Steroid Tapering Therapy
|
|
|
Experimental: SDNS:Fecal microbiota transplantation group
Fecal microbiota transplantation and traditional treatment plan
|
FMT was slowly administered to the patient's small intestine with fecal suspension under anesthesia and patients received a second transplant through oral administration freeze-dried capsules containing the fecal matter.
Other Names:
|
|
No Intervention: SRNS control group
Conventional treatment plan: Steroid + calcineurin inhibitors (cyclosporine or tacrolimus)
|
|
|
Experimental: SRNS:Fecal microbiota transplantation group
Conventional treatment plan + fecal microbiota transplantation
|
FMT was slowly administered to the patient's small intestine with fecal suspension under anesthesia and patients received a second transplant through oral administration freeze-dried capsules containing the fecal matter.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
24h urinary protein
Time Frame: follow-up visits (weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48) every 4 weeks from the beginning of medication to our renal specialist clinic for drug efficacy evaluation and safety testing
|
24-hour urine protein by urine collection
|
follow-up visits (weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48) every 4 weeks from the beginning of medication to our renal specialist clinic for drug efficacy evaluation and safety testing
|
|
Gut microbiota
Time Frame: immediately Before FMT, immediately before second FMT, one month after second FMT
|
Collect fecal samples
|
immediately Before FMT, immediately before second FMT, one month after second FMT
|
|
Zonulin
Time Frame: immediately Before FMT, immediately before second FMT, one month after second FMT
|
collect blood samples
|
immediately Before FMT, immediately before second FMT, one month after second FMT
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum creatinine
Time Frame: immediately Before FMT, immediately before second FMT, one month after second FMT
|
collect blood samples
|
immediately Before FMT, immediately before second FMT, one month after second FMT
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2025
Primary Completion (Estimated)
April 1, 2026
Study Completion (Estimated)
April 1, 2028
Study Registration Dates
First Submitted
May 26, 2025
First Submitted That Met QC Criteria
June 3, 2025
First Posted (Actual)
June 4, 2025
Study Record Updates
Last Update Posted (Actual)
June 4, 2025
Last Update Submitted That Met QC Criteria
June 3, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Shanghai Children's Hospital
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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