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AgingEarly Phase 1STEP-agingNCT05598112

Effect of Gut Microbiome Intervention on Aging Via Oral FMT

A Early Phase 1 study testing FMT capsules in people with Aging and Frailty, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 6 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 70 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Aging, Frailty
What is being tested?
FMT capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
210 participants
Where
6 sitesChina
Study dates
24 Apr 2023to 31 Dec 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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 70 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

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

Who cannot join

  • Participants of other clinical trials;
  • Antibiotics or probiotics usage within last 4 weeks;
  • 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]);
  • History of large atherosclerotic cerebral infarction or hemorrhagic stroke (not including lacunar infarction and transient ischemic attack [TIA]);
  • 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;
  • NYHA class III-IV heart failure; Hospitalization for chronic heart failure exacerbation within last 6 months;
Show all 19Show fewer
  • Severe valvular diseases; Potential for surgery or percutaneous valve replacement within the study period;
  • Dilated cardiomyopathy; Hypertrophic cardiomyopathy; Rheumatic heart disease; Congenital heart disease;
  • History of dementia, Parkinson's disease, intracranial infection, intracranial tumor, schizophrenia, anxiety, depression;
  • History of neurosurgical operation;
  • 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;
  • Hypertension with uncontrolled blood pressure ≥180/110mmHg;
  • Diabetes Mellitus with uncontrolled fasting glucose level ≥200mg/dl (11.1mmol/L), or HbA1C>8%;
  • Addicted to alcohol; Use of medication influencing cognitive function(i.e., antihistamine, antipsychotic);
  • General anesthesia within last 3 months;
  • Other severe diseases influencing the entry or survival of participants, such as malignant tumor or acquired immune deficiency syndrome, life expectancy <1 year;
  • Impaired verbal communication who are incapable of providing their own informed consent, or incapable of self-care;
  • Special diet influencing microbiota (i.e. vegetarian);
  • Other conditions inappropriate for recruitment according to the investigators.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Luyun Fan, MD,PhD contact

01081992131

katevan@163.com

Jun Cai, MD,PhD contact

caijun7879@126.com

6 sites in 1 country

China6 sites, 6 recruiting

  • Beijing Chao-yang Hospital, Capital Medical University

    Beijing, Beijing Municipality

    Yifan Fan, MD

    Recruiting

  • Beijing Hospital

    Beijing, Beijing Municipality

    Ni Zhang, MD

    Recruiting

  • Chinese People's Liberation Army (PLA) General Hospital

    Beijing, Beijing Municipality

    Guogang Xu, MD

    Recruiting

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing Municipality

    Jing Li, MD

    Recruiting

  • Zhejiang Hospital

    Hangzhou, Zhejiang

    Wei Yu, MD

    Recruiting

  • Huadong Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality

    Kailei Shi, MD

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
Aging, Frailty
Being tested
FMT capsules, Placebo capsules
Keywords
Aging, Frailty, Microbiome, Treatment, Fecal Microbiota Transplantation
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FMT capsulesBiological

    FMT capsules containing extensively screened donor stool.

  • Placebo capsulesOther

    Placebo capsules that do not contain donor stool or any active drug.

Study groups in NCT05598112
Study groupRoleWhat they receive
FMT capsulesExperimentalFMT 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.
Receives: Biological: FMT capsules
Placebo capsulesPlacebo comparatorPlacebo 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.
Receives: Other: Placebo capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants with reduced frailty score at week 96 follow-up

    Frailty score via CHS criteria of five frailty components, compared with baseline

    Measured: week 96

Secondary outcomes (25)

  1. Proportion of participants with reduced frailty score at week 12 follow-up

    Frailty score via CHS criteria of five frailty components, compared with baseline

    Measured: week 12

  2. Proportion of participants with reduced frailty score at week 24 follow-up

    Frailty score via CHS criteria of five frailty components, compared with baseline

    Measured: week 24

  3. Proportion of participants with reduced frailty score at week 48 follow-up

    Frailty score via CHS criteria of five frailty components, compared with baseline

    Measured: week 48

  4. Proportion of participants with reduced frailty score at week 72 follow-up

    Frailty score via CHS criteria of five frailty components, compared with baseline

    Measured: week 72

  5. Change from baseline in Frailty score

    Frailty score via CHS criteria of five frailty components, ranging from 0 to 5, with higher score indicating worse outcome

    Measured: week 12, week 24, week 48, week 72, week 96, compared with baseline

  6. Change from baseline in telomere length

    Change from baseline in telomere length

    Measured: week 48, week 96

  7. Change from baseline in Cognitive assessment via Mini Mental State Examination(MMSE)

    MMSE (Mini Mental State Examination) ranging from 0 to 30, with lower score indicating worse outcome

    Measured: week 24, week 48, week 72, week 96, compared with baseline

  8. Change from baseline in Cognitive assessment via Montreal Cognitive Assessment(MoCA)

    MoCA (Montreal Cognitive Assessment) ranging from 0 to 30, with lower score indicating worse outcome

    Measured: week 24, week 48, week 72, week 96, compared with baseline

  9. Change from baseline in Hippocampal volumes

    Hippocampal volumes evaluated by Magnet Resonance Imaging

    Measured: week 48, week 96

  10. Change from baseline in cognitive biomarkers

    plasma levels of cognitive biomarkers for BDNF、tau、Aβ-40、Aβ42

    Measured: week 12, week 24, week 48, week 72, week 96

  11. Change from baseline in inflammatory biomarkers

    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)

    Measured: week 12, week 24, week 48, week 72, week 96

  12. Change from baseline in Intestinal Microbiota Composition Pre- and Post-intervention via Metagenomic Analysis

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

    1. Randomisation
    2. Change in Office SBP

    Measured: week 12, week 24, week 48, week 72, week 96

  13. Change from baseline in Intestinal Microbiota Function assessed by KEGG Orthology (KO) Pre- and Post-intervention via Metagenomic Analysis

    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

    Measured: week 12, week 24, week 48, week 72, week 96

  14. Change from baseline in Plasma Metabolite Composition Pre- and Post-intervention via Metabolomic Analysis

    Change in Plasma Metabolite Composition Pre-and Post-intervention (FMT or Placebo) via Metabolomic Analysis

    Measured: week 12, week 24, week 48, week 72, week 96

  15. Change from baseline in Ankle-Brachial Blood Pressure Index(ABI)

    Change for ABI as an objective measurement of arterial insufficiency based on the ratio of ankle systolic pressure to brachial systolic pressure.

    Measured: week 48, week 96

  16. Change from baseline in Pulse wave velocity(PWV)

    Change for Pulse wave velocity(PWV)

    Measured: week 48, week 96

  17. Number of Participants with Adverse Events (AEs) as a Measure of Safety

    Number of Participants with Adverse Events (AEs) as a Measure of Safety

    Measured: week 12, week 24, week 48, week 72, week 96

  18. Change from baseline in Body Mass Index (BMI)

    Change for Body Mass Index

    Measured: week 4, week 8, week 12, week 24, week 48, week 72, week 96

  19. Change from baseline in office SBP

    change for office systolic blood pressure(SBP)

    Measured: week 4, week 8, week 12, week 24, week 48, week 72, week 96

  20. Change from baseline in office DBP

    change for office diastolic blood pressure(DBP)

    Measured: week 4, week 8, week 12, week 24, week 48, week 72, week 96

  21. Change from baseline in Blood Lipid Level

    Change for Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol)

    Measured: week 12, week 24, week 48, week 96

  22. Change from baseline in blood fasting glucose level

    Change for blood fasting glucose level

    Measured: week 12, week 24, week 48, week 96

  23. Change from baseline in blood HbA1c level

    Change for blood glycosylated hemoglobin, type A1C (HbA1c) level

    Measured: week 12, week 24, week 48, week 96

  24. Change from baseline in physical function assessment via 6MWT

    6-minute walking test(6MWT)

    Measured: week 12, week 24, week 48, week 72, week 96

  25. Change from baseline in daily function assessment via Activity of Daily Living (ADL)

    Activity of Daily Living (ADL) ranging from 0 to 100, with lower score indicating worse outcome

    Measured: week 12, week 24, week 48, week 72, week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2022
  2. Study start24 Apr 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05598112
Sponsor's protocol ID
2022-1784
Acronym
STEP-aging
Status last verified
Dec 2025
First submitted
20 Oct 2022
Last updated
31 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The collected data, study protocol, and SAP are planned to be shared after the study ends 3 years later (anticipated)

Publications

  • Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

    PubMed 11253156

  • Ghosh TS, Rampelli S, Jeffery IB, Santoro A, Neto M, Capri M, Giampieri E, Jennings A, Candela M, Turroni S, Zoetendal EG, Hermes GDA, Elodie C, Meunier N, Brugere CM, Pujos-Guillot E, Berendsen AM, De Groot LCPGM, Feskins EJM, Kaluza J, Pietruszka B, Bielak MJ, Comte B, Maijo-Ferre M, Nicoletti C, De Vos WM, Fairweather-Tait S, Cassidy A, Brigidi P, Franceschi C, O'Toole PW. Mediterranean diet intervention alters the gut microbiome in older people reducing frailty and improving health status: the NU-AGE 1-year dietary intervention across five European countries. Gut. 2020 Jul;69(7):1218-1228. doi: 10.1136/gutjnl-2019-319654. Epub 2020 Feb 17.

    PubMed 32066625

  • Ng TP, Feng L, Nyunt MS, Feng L, Niti M, Tan BY, Chan G, Khoo SA, Chan SM, Yap P, Yap KB. Nutritional, Physical, Cognitive, and Combination Interventions and Frailty Reversal Among Older Adults: A Randomized Controlled Trial. Am J Med. 2015 Nov;128(11):1225-1236.e1. doi: 10.1016/j.amjmed.2015.06.017. Epub 2015 Jul 6.

    PubMed 26159634

  • Mullish BH, Quraishi MN, Segal JP, McCune VL, Baxter M, Marsden GL, Moore DJ, Colville A, Bhala N, Iqbal TH, Settle C, Kontkowski G, Hart AL, Hawkey PM, Goldenberg SD, Williams HRT. The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridium difficile infection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines. Gut. 2018 Nov;67(11):1920-1941. doi: 10.1136/gutjnl-2018-316818. Epub 2018 Aug 28.

    PubMed 30154172

  • Kundu P, Lee HU, Garcia-Perez I, Tay EXY, Kim H, Faylon LE, Martin KA, Purbojati R, Drautz-Moses DI, Ghosh S, Nicholson JK, Schuster S, Holmes E, Pettersson S. Neurogenesis and prolongevity signaling in young germ-free mice transplanted with the gut microbiota of old mice. Sci Transl Med. 2019 Nov 13;11(518):eaau4760. doi: 10.1126/scitranslmed.aau4760.

    PubMed 31723038

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing FMT capsules in people with Aging and Frailty, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 6 sites 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 2 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Luyun Fan, MD,PhD (01081992131, katevan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with reduced frailty score at week 96 follow-up (time frame: week 96). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05598112, which also lists 5 linked publications.

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 31 Dec 2025.

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