IgA NephropathyNCT05182775
A Clinical Research on the Use of Fecal Bacteria Transplantation for Treatment of IgA Nephropathy
A study testing Fecal bacteria transplantation in people with IgA Nephropathy, run by Shanxi Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- Fecal bacteria transplantation
- Type of treatment
- Vaccines, Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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)
Who cannot join
- (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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- IgA Nephropathy
- Being tested
- Fecal bacteria transplantation
- Keywords
- IgAN, FMT
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal bacteria transplantationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Fecal bacteria transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour urinary protein quantification
Percentage of subjects with 24-hour urinary protein quantification < 0.5g/d
Measured: 6 months after the end of the trial
Secondary outcomes (1)
BP
Percentage of subjects with BP < 130 / 80mmHg
Measured: 6 months after the end of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Case study
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanxi Provincial People's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, 李亚峰, Shanxi Provincial People's Hospital
- Investigators
- Ya-feng Li, Professor, Principal investigator, Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182775
- Sponsor's protocol ID
- ShanxiPPH
- Status last verified
- Nov 2023
- First submitted
- 22 Dec 2021
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Research on the Use of Fecal Bacteria Transplantation for Treatment of IgA Nephropathy
- ClinicalTrials.gov ID
- NCT05182775
- Acronym / sponsor ID
- ShanxiPPH
- Conditions
- IgA Nephropathy
- Keywords
- IgAN, FMT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Shanxi Provincial People's HospitalOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case study
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Procedure: Fecal bacteria transplantationThis 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (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)
Key exclusion criteria (1 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal bacteria transplantationFecal 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. | Procedure or surgery | experimental group |
Primary outcome
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
1 secondary outcome
BP
Time frame: 6 months after the end of the trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Yes. 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
Related trials for IgA Nephropathy
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 3
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA Nephropathy (IgAN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ya-feng Li, Professor principal investigator
Shanxi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal bacteria transplantation in people with IgA Nephropathy, run by Shanxi Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour urinary protein quantification (time frame: 6 months after the end of the trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.