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

Early Phase 1Not Yet RecruitingNCT07003438

Zhang Ting120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Steroid-Resistant Nephrotic Syndrome Steroid-Dependent Nephrotic Syndrome

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

24h urinary protein

24-hour urine protein by urine collection

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

Gut microbiota

Collect fecal samples

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

Zonulin

collect blood samples

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

Secondary Outcomes

Serum creatinine

collect blood samples

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

Data from ClinicalTrials.gov

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