Clinical trial NCT06220994: the Gut Microbiome and Metabolomics in Chronic Lower extreMities Threatening Ischemia
Official title: The Gut Microbiome and Metabolomics Among Chronic Lower Extremities Threatening Ischemia Patients in China - a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Limb-threatening Ischemia
Microtia
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The Chronic limb-threatening ischemia patients and health adult without history of atherosclerotic plaque, coronary heart disease or stroke, attending Tsinghua Chang Gung Hospital in Beijing.

Brief summary: Intestinal floras and their metabolites are involved in progressing metabolic and cardiovascular diseases. However, currently, articles related to the relationship between intestinal floras and atherosclerosis mainly focus on coronary atherosclerotic disease (CAD) population, or atherosclerosis model animals such as ApoE-/-, LDLR-/- high-fat diet mice, and there are few studies on Chronic limb-threatening ischemia (CLTI). CLTI and CAD have a similar pathological basis of atherosclerosis. It is unclear whether intestinal flora plays an essential role in the occurrence and development of CLTI. This project aims to explore the relation between microorganisms, metabolites, and CLTI.

Detailed description: This project aims to study the intestinal flora and its metabolites in patients with CLTI, explore whether CLTI patients and CAD patients have their own characteristic flora, analyze the microorganisms and metabolites markers of poor prognosis in patients with CLTI, and screen out the key differential bacteria and metabolites that inhibit the progress of CLTI, in order to provide new insights and research basis for the treatment of CLTI.

Eligibility criteria: Inclusion Criteria:

Control group: sex - and age-matched healthy people (without history of atherosclerotic plaque, coronary heart disease or stroke).

Case group: resting pain for at least 2 weeks with at least one hemodynamic index: ABI\<0.4,AP\<50mmHg, TP or TCPO2\<30mmHg. Tissue defects (ulceration or gangrene) persisted for at least 2 weeks with at least one significant PAD objective evidence: ABI\<0.8, AP\<100mmHg, TP or TCPO2\<60mmHg.

Exclusion Criteria:

1. Patients with inflammatory bowel disease, autoimmune diseases, malignancies, infectious diseases, and severe liver and kidney dysfunction (cirrhosis, CKD stage 4 and 5).
2. Patients with thromboembolic angiitis, arterial embolism, and takayasu.
3. Patients who have used probiotics or antibiotics in the last 2 months.
4. After interventional surgery and amputation below the knee or above knee.

Primary outcomes:
measure: Bacteria or metabolites associated with prolonged survival time without above-knee amputation
timeFrame: 3years.
Secondary outcomes:
measure: Key bacteria in CLTI
timeFrame: up to 1 week
measure: Key plasma metabolites in CLTI
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Chang Gung Hosipital
state: Beijing
Study officials:
affiliation: Beijing Tsinghua Chang Gung Hospital
name: Weiwei Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: