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

NCT07003438 | Not Yet Recruiting Early Phase 1

• 1 other identifier: Shanghai Children's Hospital
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Steroid-Resistant Nephrotic Syndrome; Steroid-Dependent Nephrotic Syndrome

Outcome Measures

Primary Outcomes (3)

• 24h urinary protein

  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

  Collect fecal samples

  immediately Before FMT, immediately before second FMT, one month after second FMT

• Zonulin

  collect blood samples

  immediately Before FMT, immediately before second FMT, one month after second FMT

Secondary Outcomes (1)

• Serum creatinine

  immediately Before FMT, immediately before second FMT, one month after second FMT

Study Arms (4)

SDNS:control group

NO INTERVENTION

Traditional treatment plan: Steroid Tapering Therapy

SDNS:Fecal microbiota transplantation group

EXPERIMENTAL

Fecal microbiota transplantation and traditional treatment plan

Drug: Fecal microbiota transplantation (FMT)

SRNS control group

NO INTERVENTION

Conventional treatment plan: Steroid + calcineurin inhibitors (cyclosporine or tacrolimus)

SRNS:Fecal microbiota transplantation group

EXPERIMENTAL

Conventional treatment plan + fecal microbiota transplantation

Drug: Fecal microbiota transplantation (FMT)

Interventions

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.

Also known as: FMT

SDNS:Fecal microbiota transplantation group; SRNS:Fecal microbiota transplantation group

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Those with concurrent infections or diseases of other organ systems, and those with abnormal renal function.

Sponsors & Collaborators

• Zhang Ting: lead

MeSH Terms

Conditions

Nephrotic Syndrome

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: June 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2028
• Last Updated: June 4, 2025

Record last verified: 2025-05