Renal Insufficiency, ChronicNCT06166667
Effect of Fecal Capsule on Chronic Kidney Disease (CKD)
A study testing Fecal Microbiota Transplant（FMT） in people with Renal Insufficiency, Chronic, run by Shanxi Provincial People's Hospital at 1 site in China.
Trial summary
By collecting blood, urine and stool samples before and after oral Enterobacteriaceae capsule (FMT) from CKD subjects, we investigated the role and related mechanisms of gut microecology in the development of CKD using a combination of metagenomic sequencing, metabolomic analysis and flow cytometry. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Fecal Microbiota Transplant（FMT）
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 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
- Subjects: Patients with chronic kidney disease (CKD)
- GFR ≥ 30 ml / min, or serum creatinine ≤ 442 μ mol/L
- Negative urine pregnancy test and no plans for pregnancy for the next 18 months, enabling effective contraception
- Age: 18-70 years
- Signed informed consent for clinical studies informed consent for treatment of patients with flora transplantation (FMT)
Who cannot join
- Had taken antibiotics for nearly 14 days
- Active systemic infections or severe infections within 1 month prior to enrollment, including HIV, HBV, HCV
- White blood cell count < 3.0x109/l; Platelet count < 80x109 / L, or had other hematologic diseases
- Presence of malignancy and other diseases with expected survival time < 3 months
- Presence of IBD, CDI, or gastrointestinal tumors
- Presence of active gastrointestinal bleeding or acute and chronic gastrointestinal inflammation
Show all 12Show fewer
- Were or had undergone FMT
- Psychosis and cognitive impairment
- History of alcohol or drug abuse
- Pregnant or lactating women
- Difficult to follow-up
- Difficult or unwilling to cooperate
Trial locations and contacts
1 site in 1 country.
About this study
By collecting blood, urine and stool samples before and after oral Enterobacteriaceae capsule (FMT) from CKD subjects, we investigated the role and related mechanisms of gut microecology in the development of CKD using a combination of metagenomic sequencing, metabolomic analysis and flow cytometry.
Read the detailed description
Patients involved in the trial received 16 capsules of Enterobacteriaceae (one course) on days 1, 8, and 15, which were provided by Dongyuan Yikang company. Patients were prohibited from taking antibiotics such as amoxicillin and Cefalexin during the trial.
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Fecal Microbiota Transplant（FMT）
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota Transplant（FMT）Procedure or surgery
Patients involved in the trial received 20 capsules of Enterobacteriaceae (one course) on days 1, 8, and 15, which were provided by Dongyuan Yikang company. Patients were prohibited from taking antibiotics such as amoxicillin and Cefalexin during the trial.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Fecal Microbiota Transplant Receives: Procedure: Fecal Microbiota Transplant（FMT） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abundance of gut microbiota
Fecal sample metagenomic sequencing
Measured: 6 months after the end of the trial
Secondary outcomes (3)
24-hour urine protein quantitative change rate
Urine sample
Measured: 6 months after the end of the trial
the density of immune cells
Blood samples
Measured: 6 months after the end of the trial
Cytokine concentration
Blood samples
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 posted12 Dec 2023
- Study start1 Mar 2023
- 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 Renal Insufficiency, ChronicStudies 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanxi Provincial People's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yafeng Li, Professor, Principal investigator, Shanxi Provincial People's Hospital (Fifth Hospital) of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166667
- Sponsor's protocol ID
- (2022) SYKLSZ No.352
- Status last verified
- May 2025
- First submitted
- 6 May 2023
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is completed，ResMan,http://www.medresman.org.cn
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fecal Capsule on Chronic Kidney Disease (CKD)
- ClinicalTrials.gov ID
- NCT06166667
- Acronym / sponsor ID
- (2022) SYKLSZ No.352
- Conditions
- Renal Insufficiency, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shanxi Provincial People's HospitalOther government
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 12 Dec 2023 (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.
By collecting blood, urine and stool samples before and after oral Enterobacteriaceae capsule (FMT) from CKD subjects, we investigated the role and related mechanisms of gut microecology in the development of CKD using a combination of metagenomic sequencing, metabolomic analysis and flow cytometry.
Detailed description
Patients involved in the trial received 16 capsules of Enterobacteriaceae (one course) on days 1, 8, and 15, which were provided by Dongyuan Yikang company. Patients were prohibited from taking antibiotics such as amoxicillin and Cefalexin during the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Procedure: Fecal Microbiota Transplant（FMT）Fecal Microbiota Transplant |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects: Patients with chronic kidney disease (CKD)
- GFR ≥ 30 ml / min, or serum creatinine ≤ 442 μ mol/L
- Negative urine pregnancy test and no plans for pregnancy for the next 18 months, enabling effective contraception
- Age: 18-70 years
- Signed informed consent for clinical studies informed consent for treatment of patients with flora transplantation (FMT)
Key exclusion criteria (12 listed)
- Had taken antibiotics for nearly 14 days
- Active systemic infections or severe infections within 1 month prior to enrollment, including HIV, HBV, HCV
- White blood cell count < 3.0x109/l; Platelet count < 80x109 / L, or had other hematologic diseases
- Presence of malignancy and other diseases with expected survival time < 3 months
- Presence of IBD, CDI, or gastrointestinal tumors
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 Microbiota Transplant（FMT）Patients involved in the trial received 20 capsules of Enterobacteriaceae (one course) on days 1, 8, and 15, which were provided by Dongyuan Yikang company. Patients were prohibited from taking antibiotics such as amoxicillin and Cefalexin during the trial. | Procedure or surgery | experimental group |
Primary outcome
Abundance of gut microbiota
Time frame: 6 months after the end of the trial
Fecal sample metagenomic sequencing
3 secondary outcomes
24-hour urine protein quantitative change rate
Time frame: 6 months after the end of the trial
the density of immune cells
Time frame: 6 months after the end of the trial
Cytokine concentration
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 16 May 2025.
- Individual participant dataSharing planned: Yes. After the study is completed，ResMan,http://www.medresman.org.cn
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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.
Yafeng Li, Professor principal investigator
Shanxi Provincial People's Hospital (Fifth Hospital) of 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 Microbiota Transplant（FMT） in people with Renal Insufficiency, Chronic, 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 5 inclusion and 12 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 16 May 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?
Abundance of gut microbiota (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 16 May 2025.