NCT05182775Completed
A Clinical Research on the Use of Fecal Bacteria Transplantation for Treatment of IgA Nephropathy
Source: ClinicalTrials.gov · Last updated 11 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The role and related mechanisms of gut microecology in the development and progression of IgA nephropathy were investigated by treating IgA nephropathy subjects with oral probiotic capsules (FMT) combined with metagenomic sequencing and metabolomic analysis.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 22 Dec 2021
- Start date
- 1 Jan 2022
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Shanxi Provincial People's Hospital
- Diseases
- IgA nephropathy
- NCT number
- NCT05182775
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 1 Jan 2022 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- (1) Secondary IgA nephropathy: such as SLE, liver cirrhosis, IgA vasculitis (2) Antibiotics in recent 14 days (3) Malignant hypertension or other uncontrollable severe hypertension (systolic blood pressure \> 160mmhg or diastolic blood pressure \> 110mmhg) (4) Active systemic infection or serious infection within 1 month before enrollment, including HIV, HBV and HCV (5) Leukocyte count \< 3.0x109 / L, or anemia (hemoglobin \< 80g / L); Platelet count \< 80x10 9 / L,Or other blood system diseases (6) There were malignant tumors and other diseases, and the expected survival time was \< 3 months (7) Severe cardiovascular and cerebrovascular diseases and intestinal dysfunction (8) There are other immune system diseases (9) Presence of IBD, CDI, or gastrointestinal tumors (10) There is active gastrointestinal bleeding or acute and chronic gastrointestinal inflammation (11) Being or having received FMT (12) Psychosis and cognitive impairment (13) History of alcohol or drug abuse
Who the study is looking for
- (1) Subjects: IgA nephropathy patients diagnosed by renal biopsy (2) After 3 \~ 6 months of ACEI / ARB treatment, urinary protein was still \> 0.5g/d (3) eGFR30 120ml/min/1.73 ㎡ (4) Unable to tolerate the side effects of glucocorticoids and immunosuppressants (5) If the urine pregnancy test is negative and there is no pregnancy plan in the next 18 months, effective contraceptive measures can be taken (6) Age: 18-70 years old (7) Inpatient (8) Sign the informed consent form for clinical research and the informed consent form for patients treated with flora transplantation (FMT)
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanxi Provincial People's Hospita Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.