Study on the Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Steroid - Dependent /Steroid-resistant Nephrotic Syndrome in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fecal microbiota transplantation (FMT).
- Who it may be relevant to
- Registry conditions: Steroid-Resistant Nephrotic Syndrome, Steroid-Dependent Nephrotic Syndrome. Basic parameters: 2 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Drug Fecal microbiota transplantation (FMT)
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.
Primary outcome measures
- 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]
- Gut microbiota [Time frame: immediately Before FMT, immediately before second FMT, one month after second FMT]
- Zonulin [Time frame: immediately Before FMT, immediately before second FMT, one month after second FMT]
Secondary outcome measures (1)
- Serum creatinine [Time frame: immediately Before FMT, immediately before second FMT, one month after second FMT]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07003438 · Shanghai Children's Hospital