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

Conditions

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
Drug: Fecal microbiota transplantation (FMT)
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:
  • FMT
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
Drug: Fecal microbiota transplantation (FMT)
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:
  • FMT

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

Zhang Ting

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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