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Study on the efficacy and safety of fecal Microbiota transplantation in the treatment of Steroid - dependent /Steroid-resistant nephrotic syndrome in Children

Study on the efficacy and safety of fecal Microbiota transplantation in the treatment of Steroid - dependent /Steroid-resistant nephrotic syndrome in Children

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103238
Enrollment
Unknown
Registered
2025-05-27
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Steroid - dependent /Steroid-resistant nephrotic syndrome in Children

Interventions

SDNS:control group:Traditional treatment plan: Steroid Tapering Therapy
SDNS:Fecal microbiota transplantation group:Traditional treatment plan + fecal microbiota transplantation
SRNS control group:Conventional treatment plan: Steroid + calcineurin inhibitors (cyclosporine or tacrolimus)
SRNS:Fecal microbiota transplantation group:Conventional treatment plan + fecal microbiota transplantation

Sponsors

Shanghai Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 18 Years

Inclusion criteria

Inclusion criteria: Patients with SDNS/SRNS, aged 2 to 18 years old, regardless of gender. Among them, the steroid-dependent dose for children with SDNS is less than 0.5mg/kg.d.

Exclusion criteria

Exclusion criteria: Those with concurrent infections or diseases of other organ systems; For those with abnormal renal function, eGFR<90ml/(min×1.73 m^2) was evaluated according to the Schwartz formula.

Design outcomes

Primary

MeasureTime frame
24h urinary protein;

Secondary

MeasureTime frame
Intestinal mucosal permeability;Gut microbiota;Fecal metabolomics;

Countries

China

Contacts

Public ContactYulin Kang

Shanghai Children's Hospital

kangyulin@sjtu.edu.cn+86 182 2199 2381

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026