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OpenTrials
Completed

NCT Number: NCT06166667

Effect of Fecal Capsule on Chronic Kidney Disease (CKD)

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.

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Key information

Conditions

Renal Insufficiency, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanxi Provincial People's Hospita

Taiyuan, Shanxi, 030012, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Fecal Microbiota Transplant（FMT）

Procedure

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.

Primary outcomes

  1. Abundance of gut microbiota

    Time frame: 6 months after the end of the trial

    Fecal sample metagenomic sequencing

Secondary outcomes

  1. 24-hour urine protein quantitative change rate

    Time frame: 6 months after the end of the trial

    Urine sample

  2. the density of immune cells

    Time frame: 6 months after the end of the trial

    Blood samples

  3. Cytokine concentration

    Time frame: 6 months after the end of the trial

    Blood samples

Sponsors and collaborators

Lead sponsor

Shanxi Provincial People's Hospital

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 12, 2023
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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