A Clinical Research on the Use of Fecal Bacteria Transplantation for Treatment of IgA Nephropathy

NCT05182775 | Completed

• 1 other identifier: ShanxiPPH
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

IgA Nephropathy

Keywords

IgAN; FMT

Outcome Measures

Primary Outcomes (1)

• 24-hour urinary protein quantification

  Percentage of subjects with 24-hour urinary protein quantification \< 0.5g/d

  6 months after the end of the trial

Secondary Outcomes (1)

• BP

  6 months after the end of the trial

Study Arms (1)

experimental group

EXPERIMENTAL

This trial is a prospective study without a control group. It is planned to recruit 15 patients with IgA nephropathy. The experimental group received fecal bacteria transplantation through FMT capsule. The researchers will judge the effectiveness and safety of fecal bacteria transplantation in the treatment of IgA nephropathy by observing the changes of monitoring indicators before and after fecal bacteria transplantation and during follow-up. Donor screening and FMT capsule preparation were completed by Dongyuan Yikang company (www.dongyuanyikang. com).The patients participating in the trial took 16 Enterobacteriaceae capsules on day 1, day 8 and day 15 respectively as a course of treatment. The researchers will collect stool samples from patients one day before taking the medicine, one week after the last taking the medicine and one month after the last taking the medicine, and analyze the intestinal flora by sequencing

Procedure: Fecal bacteria transplantation

Interventions

Fecal bacteria transplantation PROCEDURE

Fecal microbiota transplantation (FMT) refers to the transplantation of functional flora from the feces of a healthy person into the gastrointestinal tract of a patient, thereby reestablishing the intestinal flora with normal function. FMT promotes the treatment of intestinal microecology by eliminating single microorganisms or certain pathogens (such as vaccines and antibiotics) and increasing beneficial bacteria (such as prebiotics and probiotics) to the reconstruction of intestinal microecology. The best treatment indication for FMT is Clostridium difficile infection, which is a treatment choice confirmed by expert consensus and guidelines in many countries and regions. Meanwhile, FMT has been used in the treatment and research of many intestinal microbiome related diseases worldwide.

experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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)

You may not qualify if:

• (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

Sponsors & Collaborators

• Shanxi Provincial People's Hospital: lead

Study Sites (1)

Shanxi Provincial People's Hospita

Taiyuan, Shanxi, 030012, China

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ya-feng Li, Professor

  Shanxi Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Case study

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 10, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 11, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Six months after the end of the study
• Access Criteria: The responsible investigator for the study may be contacted for access to data from this trial

Locations

CN (1)