Effect of Gut Microbiome Intervention on Aging Via Oral FMT (STEP-aging)

December 24, 2025 updated by: Jun Cai, Chinese Academy of Medical Sciences, Fuwai Hospital

Effect of Fecal Microbiota Transplantation on Aging and the Underlying Mechanism of Gut Microbiome Restoration: a Randomized Clinical Trial

A severe public health issue facing global population is aging. Increasing preclinical and clinical data indicate the contribution of gut microbiome on aging and aging-related diseases such as cardiovascular disease, Alzheimer Disease, and diabetes. Interventions on microbiota are developed including prebiotics, probiotics, and fecal microbial transplantation (FMT). FMT via oral capsules also advances in recent with limited safety concerns compared with invasive routes. A hypothesis is thus raised that gut microbiome intervention via oral FMT can be a potential safe approach to encourage healthy aging, with multiple aspects evaluated for clinical phenotype of frailty, anthropometric measurement, cognitive function, cardiovascular aging, physical function, living activity, hippocampal volume, telomere length, cognitive biomarkers, inflammatory biomarkers, altered microbial composition and metabolites.

Study Overview

Status

Status

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

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

Objective: To explore the effect, safety and underlying mechanisms of gut microbiome intervention via FMT on aging. Study Design: A multi-center, randomized, blinded, placebo-controlled pilot study. Data quality control and statistical analysis: The investigators have invited professional statistic analysts to assist analyzing data and a third party to supervise data quality. Ethics: The Ethics Committee of Fuwai Hospital approved this study. Informed consents before patient enrollment are required.

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 (Estimated)

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.
210

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.
  • Early Phase 1

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
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Beijing Chao-Yang Hospital, Capital Medical University
        • Contact:
          • Yifan Fan, MD
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Beijing Hospital
        • Contact:
          • Ni Zhang, MD
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Chinese People's Liberation Army (PLA) General Hospital
        • Contact:
          • Guogang Xu, MD
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Xuanwu Hospital, Capital Medical University
        • Contact:
          • Jing Li, MD
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Huadong Hospital affiliated to Fudan University
        • Contact:
          • Kailei Shi, MD
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Hospital
        • Contact:
          • Wei Yu, MD

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

66 years to 81 years (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age 70-85 years.
  2. Patients with informed consent after thorough explanation.

Exclusion Criteria:

  1. Participants of other clinical trials;
  2. Antibiotics or probiotics usage within last 4 weeks;
  3. Severe hepatic or renal diseases ((ALT >3 times the upper limit of normal value, or end stage renal disease on dialysis or eGFR <30 mL/min/1.73 m2, or serum creatinine >2.5 mg/dl [>221 μmol/L]);
  4. History of large atherosclerotic cerebral infarction or hemorrhagic stroke (not including lacunar infarction and transient ischemic attack [TIA]);
  5. Hospitalization for myocardial infarction within last 6 months; Coronary revascularization (PCI or CABG) within last 12 months; Planned for PCI or CABG in the next 6 months;
  6. NYHA class III-IV heart failure; Hospitalization for chronic heart failure exacerbation within last 6 months;
  7. Severe valvular diseases; Potential for surgery or percutaneous valve replacement within the study period;
  8. Dilated cardiomyopathy; Hypertrophic cardiomyopathy; Rheumatic heart disease; Congenital heart disease;
  9. History of dementia, Parkinson's disease, intracranial infection, intracranial tumor, schizophrenia, anxiety, depression;
  10. History of neurosurgical operation;
  11. History of gastrointestinal tumor, gastrointestinal surgery, inflammatory bowel disease; Hospitalization for peptic ulcer disease exacerbation within last 6 months or anticipated hospitalization for peptic ulcer disease the next 6 months;
  12. Hypertension with uncontrolled blood pressure ≥180/110mmHg;
  13. Diabetes Mellitus with uncontrolled fasting glucose level ≥200mg/dl (11.1mmol/L), or HbA1C>8%;
  14. Addicted to alcohol; Use of medication influencing cognitive function(i.e., antihistamine, antipsychotic);
  15. General anesthesia within last 3 months;
  16. Other severe diseases influencing the entry or survival of participants, such as malignant tumor or acquired immune deficiency syndrome, life expectancy <1 year;
  17. Impaired verbal communication who are incapable of providing their own informed consent, or incapable of self-care;
  18. Special diet influencing microbiota (i.e. vegetarian);
  19. Other conditions inappropriate for recruitment according to the investigators.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

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: FMT capsules
FMT capsules containing extensively screened donor stool. FMT capsules will be orally taken on week 0, week 4, week 8, week 12, week 24, week 28, week 32, week 36, week 48, week 52, week 56, week 60, week 72, week 76, week 80, week 84.
Biological: FMT capsules
FMT capsules containing extensively screened donor stool.
Placebo Comparator: Placebo capsules
Placebo capsules that do not contain donor stool or any active drug. Placebo capsules will be orally taken on week 0, week 4, week 8, week 12, week 24, week 28, week 32, week 36, week 48, week 52, week 56, week 60, week 72, week 76, week 80, week 84.
Other: Placebo capsules
Placebo capsules that do not contain donor stool or any active drug.

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
Proportion of participants with reduced frailty score at week 96 follow-up
Time Frame: week 96
Frailty score via CHS criteria of five frailty components, compared with baseline
week 96

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
Proportion of participants with reduced frailty score at week 12 follow-up
Time Frame: week 12
Frailty score via CHS criteria of five frailty components, compared with baseline
week 12
Proportion of participants with reduced frailty score at week 24 follow-up
Time Frame: week 24
Frailty score via CHS criteria of five frailty components, compared with baseline
week 24
Proportion of participants with reduced frailty score at week 48 follow-up
Time Frame: week 48
Frailty score via CHS criteria of five frailty components, compared with baseline
week 48
Proportion of participants with reduced frailty score at week 72 follow-up
Time Frame: week 72
Frailty score via CHS criteria of five frailty components, compared with baseline
week 72
Change from baseline in Frailty score
Time Frame: week 12, week 24, week 48, week 72, week 96, compared with baseline
Frailty score via CHS criteria of five frailty components, ranging from 0 to 5, with higher score indicating worse outcome
week 12, week 24, week 48, week 72, week 96, compared with baseline
Change from baseline in telomere length
Time Frame: week 48, week 96
Change from baseline in telomere length
week 48, week 96
Change from baseline in Cognitive assessment via Mini Mental State Examination(MMSE)
Time Frame: week 24, week 48, week 72, week 96, compared with baseline
MMSE (Mini Mental State Examination) ranging from 0 to 30, with lower score indicating worse outcome
week 24, week 48, week 72, week 96, compared with baseline
Change from baseline in Cognitive assessment via Montreal Cognitive Assessment(MoCA)
Time Frame: week 24, week 48, week 72, week 96, compared with baseline
MoCA (Montreal Cognitive Assessment) ranging from 0 to 30, with lower score indicating worse outcome
week 24, week 48, week 72, week 96, compared with baseline
Change from baseline in Hippocampal volumes
Time Frame: week 48, week 96
Hippocampal volumes evaluated by Magnet Resonance Imaging
week 48, week 96
Change from baseline in cognitive biomarkers
Time Frame: week 12, week 24, week 48, week 72, week 96
plasma levels of cognitive biomarkers for BDNF、tau、Aβ-40、Aβ42
week 12, week 24, week 48, week 72, week 96
Change from baseline in inflammatory biomarkers
Time Frame: week 12, week 24, week 48, week 72, week 96
plasma levels of inflammatory biomarkers for hs-C-reactive protein (hs-CRP)、 interleukin 6(IL-6)、interleukin 1 β(IL-1 β) 、interleukin10 (IL-10)、tumor necrosis factor α(TNF-α)
week 12, week 24, week 48, week 72, week 96
Change from baseline in Intestinal Microbiota Composition Pre- and Post-intervention via Metagenomic Analysis
Time Frame: week 12, week 24, week 48, week 72, week 96

Change in Intestinal Microbiota Composition Pre- and Post-intervention (FMT or Placebo) via Metagenomic Analysis, stratified by:

  1. Randomisation
  2. Change in Office SBP
week 12, week 24, week 48, week 72, week 96
Change from baseline in Intestinal Microbiota Function assessed by KEGG Orthology (KO) Pre- and Post-intervention via Metagenomic Analysis
Time Frame: week 12, week 24, week 48, week 72, week 96

Change in Intestinal Microbiota Function assessed by KEGG Orthology (KO) Pre- and Post-intervention (FMT or Placebo) via Metagenomic Analysis, stratified by:

  1. Randomisation
  2. Change in Office SBP
week 12, week 24, week 48, week 72, week 96
Change from baseline in Plasma Metabolite Composition Pre- and Post-intervention via Metabolomic Analysis
Time Frame: week 12, week 24, week 48, week 72, week 96
Change in Plasma Metabolite Composition Pre-and Post-intervention (FMT or Placebo) via Metabolomic Analysis
week 12, week 24, week 48, week 72, week 96
Change from baseline in Ankle-Brachial Blood Pressure Index(ABI)
Time Frame: week 48, week 96
Change for ABI as an objective measurement of arterial insufficiency based on the ratio of ankle systolic pressure to brachial systolic pressure.
week 48, week 96
Change from baseline in Pulse wave velocity(PWV)
Time Frame: week 48, week 96
Change for Pulse wave velocity(PWV)
week 48, week 96
Number of Participants with Adverse Events (AEs) as a Measure of Safety
Time Frame: week 12, week 24, week 48, week 72, week 96
Number of Participants with Adverse Events (AEs) as a Measure of Safety
week 12, week 24, week 48, week 72, week 96
Change from baseline in Body Mass Index (BMI)
Time Frame: week 4, week 8, week 12, week 24, week 48, week 72, week 96
Change for Body Mass Index
week 4, week 8, week 12, week 24, week 48, week 72, week 96
Change from baseline in office SBP
Time Frame: week 4, week 8, week 12, week 24, week 48, week 72, week 96
change for office systolic blood pressure(SBP)
week 4, week 8, week 12, week 24, week 48, week 72, week 96
Change from baseline in office DBP
Time Frame: week 4, week 8, week 12, week 24, week 48, week 72, week 96
change for office diastolic blood pressure(DBP)
week 4, week 8, week 12, week 24, week 48, week 72, week 96
Change from baseline in Blood Lipid Level
Time Frame: week 12, week 24, week 48, week 96
Change for Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol)
week 12, week 24, week 48, week 96
Change from baseline in blood fasting glucose level
Time Frame: week 12, week 24, week 48, week 96
Change for blood fasting glucose level
week 12, week 24, week 48, week 96
Change from baseline in blood HbA1c level
Time Frame: week 12, week 24, week 48, week 96
Change for blood glycosylated hemoglobin, type A1C (HbA1c) level
week 12, week 24, week 48, week 96
Change from baseline in physical function assessment via 6MWT
Time Frame: week 12, week 24, week 48, week 72, week 96
6-minute walking test(6MWT)
week 12, week 24, week 48, week 72, week 96
Change from baseline in daily function assessment via Activity of Daily Living (ADL)
Time Frame: week 12, week 24, week 48, week 72, week 96
Activity of Daily Living (ADL) ranging from 0 to 100, with lower score indicating worse outcome
week 12, week 24, week 48, week 72, week 96

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.
Chinese Academy of Medical Sciences, Fuwai 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: Jun Cai, MD,PhD, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Chinese Institutes for Medical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
April 24, 2023

Primary Completion (Estimated)

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, 2026

Study Completion (Estimated)

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, 2027

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).
October 20, 2022

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.
October 27, 2022

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.
October 28, 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.
December 31, 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.
December 24, 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.
December 1, 2025

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.
  • 2022-1784

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The collected data, study protocol, and SAP are planned to be shared after the study ends 3 years later (anticipated)

IPD Sharing Time Frame

after the study ends 3 years later (anticipated)

IPD Sharing Access Criteria

Access to these deidentified data will be required for written permission from the responsible investigation center and only for qualified researchers.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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