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

Zhang Ting

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Steroid-Resistant Nephrotic Syndrome; Steroid-Dependent Nephrotic Syndrome

Treatments: Drug: Fecal microbiota transplantation (FMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT07003438

Shanghai Children's Hospital

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups

SDNS:control group

No Intervention group

Description:

Traditional treatment plan: Steroid Tapering Therapy

SDNS:Fecal microbiota transplantation group

Experimental group

Description:

Fecal microbiota transplantation and traditional treatment plan

Treatment:

Drug: Fecal microbiota transplantation (FMT)

SRNS control group

No Intervention group

Description:

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

SRNS:Fecal microbiota transplantation group

Experimental group

Description:

Conventional treatment plan + fecal microbiota transplantation

Treatment:

Drug: Fecal microbiota transplantation (FMT)