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

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.

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Key information

Conditions

Steroid-Resistant Nephrotic Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrosis Nephrotic Syndrome Steroid-Dependent Nephrotic Syndrome Urogenital Diseases Urologic Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fecal microbiota transplantation (FMT)

Drug

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

Primary outcomes

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
Gut microbiota

Time frame: immediately Before FMT, immediately before second FMT, one month after second FMT

Collect fecal samples
Zonulin

Time frame: immediately Before FMT, immediately before second FMT, one month after second FMT

collect blood samples

Secondary outcomes

Serum creatinine

Time frame: immediately Before FMT, immediately before second FMT, one month after second FMT

collect blood samples

Sponsors and collaborators

Lead sponsor

Zhang Ting

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2028
First posted: Jun 4, 2025
Registry last updated: Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed