Effect of Gut Microbiome Intervention on Aging Via Oral FMT

NCT05598112 | Recruiting Early Phase 1 DMC

• 1 other identifier: 2022-1784
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 6

Brief 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. 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.

Conditions

Aging; Frailty

Keywords

Aging; Frailty; Microbiome; Treatment; Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (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

  week 96

Secondary Outcomes (25)

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

  week 12

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

  week 24

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

  week 48

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

  week 72

• Change from baseline in Frailty score

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

Study Arms (2)

FMT capsules

EXPERIMENTAL

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

Placebo capsules

PLACEBO COMPARATOR

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

Interventions

Placebo capsules OTHER

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

Placebo capsules

FMT capsules BIOLOGICAL

FMT capsules containing extensively screened donor stool.

FMT capsules

Eligibility Criteria

• Age: 70 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (6)

Beijing Chao-yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Beijing Hospital

Beijing, Beijing Municipality, China

RECRUITING

Chinese People's Liberation Army (PLA) General Hospital

Beijing, Beijing Municipality, China

RECRUITING

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Huadong Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Zhejiang Hospital

Hangzhou, Zhejiang, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 11253156 RESULT

• 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.

  PMID: 32066625 RESULT

• 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.

  PMID: 26159634 RESULT

• 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.

  PMID: 30154172 RESULT

• 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.

  PMID: 31723038 RESULT

MeSH Terms

Conditions

Frailty

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Jun Cai, MD,PhD

  Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Chinese Institutes for Medical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luyun Fan, MD,PhD

CONTACT

01081992131; katevan@163.com

Jun Cai, MD,PhD

CONTACT

caijun7879@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 28, 2022
• Study Start: April 24, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after the study ends 3 years later (anticipated)
• Access Criteria: Access to these deidentified data will be required for written permission from the responsible investigation center and only for qualified researchers.

Locations

CN (6)