An Early Phase 1 interventional study of Fecal microbiota transplantation (FMT) in Steroid-Resistant Nephrotic Syndrome and Steroid-Dependent Nephrotic Syndrome, sponsored by Zhang Ting. Not yet recruiting. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-06-04.
Sponsored by Zhang Ting · Early Phase 1, Interventional, and Treatment
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.
191 studies on the registry are indexed under Nephrotic Syndrome; 65 are open to participants now.
This study's planned enrollment of 120 is above the median of 46 across 122 interventional studies indexed under Nephrotic Syndrome.
Browse Nephrotic Syndrome studies →This is the only study on the registry with Zhang Ting as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Traditional treatment plan: Steroid Tapering Therapy
Fecal microbiota transplantation and traditional treatment plan
Drug: Fecal microbiota transplantation (FMT)
Conventional treatment plan: Steroid + calcineurin inhibitors (cyclosporine or tacrolimus)
Conventional treatment plan + fecal microbiota transplantation
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.
Also known as: FMT
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
Serum creatinine
collect blood samples
Time frame: immediately Before FMT, immediately before second FMT, one month after second FMT
No study locations are listed for this record.
Start is estimated for Jun 2025; primary completion for Apr 2026, 10 months later.
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This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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