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NCT07003438
Study on the Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Steroid - Dependent /Steroid-resistant Nephrotic Syndrome in Children
EARLY_PHASE1 trial testing Fecal microbiota transplantation (FMT) in Steroid-Resistant Nephrotic Syndrome in 120 participants. Not yet recruiting.
1 April 2026
Quick facts
| Lead sponsor | Zhang Ting |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 1 June 2025 |
| Primary completion | 1 April 2026 |
| Estimated completion | 1 April 2028 |
Drugs / interventions tested
- Fecal microbiota transplantation (FMT) — full drug profile →
Conditions studied
- Steroid-Resistant Nephrotic Syndrome — all drugs for Steroid-Resistant Nephrotic Syndrome →
- Steroid-Dependent Nephrotic Syndrome — all drugs for Steroid-Dependent Nephrotic Syndrome →
Sponsor
Zhang Ting
Who can join
Adults 2 to 18, any sex, with Steroid-Resistant Nephrotic Syndrome or Steroid-Dependent Nephrotic Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07003438
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Fecal microbiota transplantation (FMT)
Trials testing the same drug.
- NCT07364617 — Fecal Microbiota Transplantation for Steroid-Refractory Acute GI GVHD · Phase 2 · not yet recruiting
- NCT07276100 — Fecal Microbiota Transplantation to RESCUE Patients With Unresectable Hcc Progressors to First Line Therapy With Atezoli · Phase 2 · recruiting
- NCT07319364 — A Real-World Study of Fecal Transplants for Cancer Therapy Side Effects · Phase 1 · recruiting
- NCT06992453 — Multi-omics Dissection of Gut Microbiome Engraftment During FMT · NA · not yet recruiting
- NCT07094984 — Comparison of Three Interventions for Antibiotic-Resistant Bacteria (ARB) Decolonization From the Gastrointestinal Tract · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07003438 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zhang Ting
- Last refreshed: 4 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07003438.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing