Effect of Intensive FMT on Primary Hypertension

Chinese Academy of Medical Sciences, Fuwai Hospital72 enrolled

Overview

Mounting preclinical and clinical evidences have proved the causal role of gut microbiota on the pathogenesis of primary hypertension. Restoration of gut microbiota ameliorated high BP in rodents and/or human cases.A hypothesis is thus raised that gut microbiome restoration can be a potential approach to ameliorate hypertension. This study will perform intense fecal microbiota transplantation (FMT) intervention via oral capsules, in comparison with placebo capsules, to investigate the effect, safety and underlying mechanisms of gut microbiome intervention on primary hypertension.

Primary hypertension is a most prevalent cardiovascular diseases, and becomes a severe global public health issue because of the high morbidity and potential risk to other cardiovascular diseases. Several animal studies and diverse patient cohorts reported that the disorder of gut microbiome correlated with hypertension. Based on the investigators' previous work findings, a casual role of gut microbiome disorder was observed in primary hypertension (Microbiome. 2017;5(1):14.), and trend of ameliorating SBP was observed after short-course FMT intervention but recovery after intervention termination(Trials. 2022;23(1):178, unpublished results). The investigators therefore developed a consecutive study of intensive FMT intervention on primary hypertension. Objective: To explore the effect, safety and underlying mechanisms of intensive FMT on primary hypertension. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypertension

Interventions

FMT capsulesBIOLOGICAL

FMT capsules containing extensively screened donor stool.

Placebo capsulesOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18\~65 years. 2. Established Diagnosis of Grade 1 Hypertension (initial diagnosis or free from antihypertensive drugs within a month): 140mmHg≤ Office SBP\<160mmHg and/or 90mmHg≤ Office DBP\<100mmHg for three measurements at different days without any antihypertensive medications, according to the"2010 Chinese Guidelines for Prevention and Treatment of Hypertension". 3. Patients with informed consent after thorough explanation. Exclusion Criteria: 1. Antibiotics or probiotics usage within last 4 weeks 2. Participants of other clinical trials related to hypertension currently or within last 3 months 3. Antihypertensive medications usage currently or within last month 4. Diagnosed secondary hypertension 5. 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 \[\>221 μmol/L\]) 6. History of large atherosclerotic cerebral infarction or hemorrhagic stroke(not including lacunar infarction and transient ischemic attack \[TIA\]) 7. 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 12 months. 8. Sustained atrial fibrillation or arrhythmias at recruitment disturbing the electronic BP measurement. 9. NYHA class III-IV heart failure; Hospitalization for chronic heart failure exacerbation within last 6 months. 10. Severe valvular diseases; Potential for surgery or percutaneous valve replacement within the study period. 11. Dilated cardiomyopathy; Hypertrophic cardiomyopathy; Rheumatic heart disease; Congenital heart disease. 12. Other severe diseases influencing the entry or survival of participants, such as malignant tumor or acquired immune deficiency syndrome. 13. Cognitive impairment or severe neuropsychiatric comorbidities who are incapable of providing their own informed consent. 14. Participants preparing for or under pregnancy and/or lactation. 15. Other conditions inappropriate for recruitment according to the investigators.

Locations (3)

The Second Affiliated Hospital of Shantou University

Shantou, Guangdong, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

The People's Hospital of Ji Xian District

Tianjin, Tianjin Municipality, China

Outcomes

Primary Outcomes

Change in Office Systolic Blood Pressure (SBP)

Time frame: From baseline to Week 8

Secondary Outcomes

Change in Office Systolic Blood Pressure (SBP)

Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 12

Change in Office Diastolic Blood Pressure (DBP)

Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12

Change in Home Systolic Blood Pressure (SBP)

Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12

Change in Home Diastolic Blood Pressure (DBP)

Change in Home Diastolic Blood Pressure (DBP), compared with baseline

Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12

Change in average SBP via 24-hour Ambulatory BP Monitoring

Time frame: Baseline, Week 4, Week 8, Week 12

Change in average DBP via 24-hour Ambulatory BP Monitoring

Time frame: Baseline, Week 4, Week 8, Week 12

Central Contacts

Jun Jun, MD,PhD

CONTACT

86-010-88392165 caijun7879@126.com

Jun Jun, MD,PhD

CONTACT

86-010-60866432 caijun7879@126.com

Data from ClinicalTrials.gov

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