BridgeMD
New treatment option for Aging
Official title Effect of Gut Microbiome Intervention on Aging Via Oral FMT
ClinicalTrials.gov ID: NCT05598112
What this study is testing
What is FMT capsules?
FMT capsules is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for aging.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 70 to 85. Healthy volunteers may be eligible.
You may be able to join if
- Age 70-85 years.
- Patients with informed consent after thorough explanation.
You likely can't join 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 \ 2.5 mg/dl [\>221...
- 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...
- NYHA class III-IV heart failure; Hospitalization for chronic heart failure exacerbation within last 6 months;
See the full eligibility criteria
- Age 70-85 years.
- Patients with informed consent after thorough explanation.
- 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 \ 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 70 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Shanghai, Shanghai Municipality, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.