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

March 6, 2025 updated by: 李亚峰, Shanxi Provincial People's Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

IgA Nephropathy (IgAN) is a serious threat to human health. The exact pathogenesis of IgAN has not been elucidated yet. Currently, there is no specific and effective treatment except supportive therapy based on renin angiotensin system inhibitor. IgAN is characterized by IgA deposits in the mesangial of the kidney, persistent hematuria, and often associated with respiratory or gastrointestinal infections. Recent studies have shown a link between human genetics, gut microbiology and the pathogenesis of IgAN. Patients with kidney disease are often accompanied by intestinal flora disorder, and intestinal flora disorder will accelerate the process of kidney disease. In recent years, multiple omics studies have found that mucosal microbial immunity is involved in the pathogenesis of IgAN, among which respiratory tract and digestive tract infections can cause or aggravate IgAN. Sporadic studies have shown that intestinal microbiome diversity in IgAN patients is lower than that in normal subjects. In IgAN patients, the abundance of beneficial bacteria such as Clostridium, Enterococcus and Lactobacillus is significantly reduced. The abundance of Ruminococcus, Lachnospiraceae and Streptococcaeae increased significantly. Previous studies by the research team confirmed a strong correlation between human genetic background, intestinal microecology, and IgAN pathogenesis. Nine Single nucleotide polymorphisms (SNPS) were associated with IgAN in 1511 IgAN patients and 4469 healthy controls. Among them, the dangerous type of genes and the intestinal bacteria (Dialister/Bacilli) reduce harmful bacteria and is associated with increased (Erysipelotrichaceae/Lachnobacterium). Using metagenomic high-throughput sequencing technology, the team further studied the intestinal microflora structure at the species level in 16 IgAN patients confirmed by biopsy and 32 healthy individuals, and showed significant differences in composition and relative abundance between the two groups. The abundance of Ruminococcus gnavus, a subgenus of Ruminococcus, increased significantly in IgAN patients. Correlation analysis showed that there was a significant positive correlation between active rumen coccus and serum IgA and pathological severity in IgAN patients. 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 beneficial bacteria) 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. Since the occurrence of IgAN is related to intestinal flora, we attempted to conduct fecal bacteria transplantation by using FMT capsules in patients with IgA nephropathy, so as to explore the effectiveness and safety of FMT in the treatment of IgA nephropathy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shanxi
      • Taiyuan, Shanxi, China, 030012
        • Shanxi Provincial People's Hospita

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • (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)

Exclusion Criteria:

  • (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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: experimental group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
24-hour urinary protein quantification
Time Frame: 6 months after the end of the trial
Percentage of subjects with 24-hour urinary protein quantification < 0.5g/d
6 months after the end of the trial

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
BP
Time Frame: 6 months after the end of the trial
Percentage of subjects with BP < 130 / 80mmHg
6 months after the end of the trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanxi Provincial People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ya-feng Li, Professor, Shanxi Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ShanxiPPH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Electronic Data Capture (EDC) system developed by national Cardiovascular Center was used to collect trial Data. EDC system has been rigorously tested and fully meets the requirements of "Quality Management Specifications for Drug Clinical Trials" and "Technical Guide for Clinical Trial Data Management". Before the system is officially launched, relevant users should be trained and tested to ensure that the system meets the test requirements. After the official launch, relevant personnel will be given the account and password. The account is bound with user roles and rights. Keep the account information properly and do not disclose the account information to others or exercise corresponding rights on behalf of others

IPD Sharing Time Frame

Six months after the end of the study

IPD Sharing Access Criteria

The responsible investigator for the study may be contacted for access to data from this trial

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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