Study on the Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Steroid - Dependent /Steroid-resistant Nephrotic Syndrome in Children

Early Phase 1

Not yet recruiting

• Conditions: Steroid-Resistant Nephrotic Syndrome; Steroid-Dependent Nephrotic Syndrome
• Interventions: Drug: Fecal microbiota transplantation (FMT)

• Registration Number: NCT07003438
• Lead Sponsor: Zhang Ting

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-26
• Study Start: 2025-06-01
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Primary Completion: 2026-04-01
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SDNS:Fecal microbiota transplantation group	Fecal microbiota transplantation (FMT)	Fecal microbiota transplantation and traditional treatment plan
SRNS:Fecal microbiota transplantation group	Fecal microbiota transplantation (FMT)	Conventional treatment plan + fecal microbiota transplantation

Primary Outcome Measures

Name	Time	Method
24h urinary protein	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
Gut microbiota	immediately Before FMT, immediately before second FMT, one month after second FMT	Collect fecal samples
Zonulin	immediately Before FMT, immediately before second FMT, one month after second FMT	collect blood samples

Secondary Outcome Measures

Name	Time	Method
Serum creatinine	immediately Before FMT, immediately before second FMT, one month after second FMT	collect blood samples