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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SDNS:control group | No Intervention | Traditional treatment plan: Steroid Tapering Therapy | |
| SDNS:Fecal microbiota transplantation group | Experimental | Fecal microbiota transplantation and traditional treatment plan |
|
| SRNS control group | No Intervention | Conventional treatment plan: Steroid + calcineurin inhibitors (cyclosporine or tacrolimus) | |
| SRNS:Fecal microbiota transplantation group | Experimental | Conventional treatment plan + fecal microbiota transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal microbiota transplantation (FMT) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 24h urinary protein | 24-hour urine protein by urine collection | 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 | immediately Before FMT, immediately before second FMT, one month after second FMT |
| Zonulin | collect blood samples | immediately Before FMT, immediately before second FMT, one month after second FMT |
| Measure | Description | Time Frame |
|---|---|---|
| Serum creatinine | collect blood samples | immediately Before FMT, immediately before second FMT, one month after second FMT |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 11, 2025 | |
| Reset | Jul 29, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 11, 2025 | Jul 29, 2025 |
| ID | Term |
|---|---|
| D009404 | Nephrotic Syndrome |
| ID | Term |
|---|---|
| D009401 | Nephrosis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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