Effect of Gut Microbiome Restoration on Primary Hypertension Via FMT

NCT04406129 | Unknown Early Phase 1

• 1 other identifier: 2017-GZ10 (Part I)
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 7

Brief Summary

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 pilot study will utilize fecal microbiota transplantation (FMT) capsules, in comparison with placebo capsules, to investigate the effect, safety and underlying mechanisms of gut microbiome restoration on primary hypertension.

Conditions

Hypertension

Keywords

Hypertension; Microbiome; Treatment; Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

• Change for Office Systolic Blood Pressure (SBP)

  Change for Office Systolic Blood Pressure (SBP)

  From baseline to Day 30

Secondary Outcomes (20)

• Change for Office SBP

  Baseline, Day 7, Day 14, Day 30, Day 60, Day 90

• Change for Office Diastolic Blood Pressure (DBP)

  Baseline, Day 7, Day 14, Day 30, Day 60, Day 90

• Change for Home Systolic Blood Pressure (SBP)

  Baseline, Day 7, Day 14, Day 30, Day 60, Day 90

• Change for Home Diastolic Blood Pressure (DBP)

  Baseline, Day 7, Day 14, Day 30, Day 60, Day 90

• Change for average SBP via 24-hour Ambulatory BP Monitoring

  Baseline, Day 30, Day 90

Study Arms (2)

FMT capsules

EXPERIMENTAL

Intervention: FMT capsules containing extensively screened donor stool. FMT capsules will be orally taken on Day 1, Day 7 (Week 1) and Day 14 (Week 2).

Biological: FMT capsules

Placebo capsules

PLACEBO COMPARATOR

Intervention: Placebo capsules that do not contain donor stool or any active drug. Placebo capsules will be orally taken on Day 1, Day 7 (Week 1) and Day 14 (Week 2).

Other: Placebo capsules

Interventions

FMT capsules BIOLOGICAL

Intervention: FMT capsules containing extensively screened donor stool.

FMT capsules

Placebo capsules OTHER

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

Placebo capsules

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18\~60 years.
• Established Diagnosis of Grade 1 Hypertension (initial diagnosis or free from antihypertensive drugs within a month): 140mmHg≤ Office SBP\<160mmHg for three measurements at different days without any antihypertensive medications, according to the "2010 Chinese Guidelines for Prevention and Treatment of Hypertension".
• Patients with informed consent after thorough explanation.

You may not qualify if:

• Antibiotics or probiotics usage within last 4 weeks
• Participants of other clinical trials related to hypertension currently or within last 3 months
• Antihypertensive medications usage currently or within last month
• Diagnosed secondary hypertension
• 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 12 months.
• Sustained atrial fibrillation or arrhythmias at recruitment disturbing the electronic BP measurement.
• 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.
• Other severe diseases influencing the entry or survival of participants, such as malignant tumor or acquired immune deficiency syndrome.
• Cognitive impairment or severe neuropsychiatric comorbidities who are incapable of providing their own informed consent.
• Participants preparing for or under pregnancy and/or lactation.
• Other conditions inappropriate for recruitment according to the investigators.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead
• National Natural Science Foundation of China: collaborator

Study Sites (7)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

NOT YET RECRUITING

The Second Affiliated Hospital of Shantou University

Shantou, Guangdong, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

RECRUITING

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

RECRUITING

Southern University of Science and Technology Hospital

Shenzhen, Shenzhen, China

RECRUITING

The People's Hospital of Ji Xian District

Tianjin, Tianjin Municipality, China

NOT YET RECRUITING

Fuwai Yunnan Cardiovascular Hospital

Kunming, Yunnan, China

RECRUITING

Related Publications (5)

• Li J, Zhao F, Wang Y, Chen J, Tao J, Tian G, Wu S, Liu W, Cui Q, Geng B, Zhang W, Weldon R, Auguste K, Yang L, Liu X, Chen L, Yang X, Zhu B, Cai J. Gut microbiota dysbiosis contributes to the development of hypertension. Microbiome. 2017 Feb 1;5(1):14. doi: 10.1186/s40168-016-0222-x.

  PMID: 28143587 BACKGROUND

• Cammarota G, Ianiro G, Tilg H, Rajilic-Stojanovic M, Kump P, Satokari R, Sokol H, Arkkila P, Pintus C, Hart A, Segal J, Aloi M, Masucci L, Molinaro A, Scaldaferri F, Gasbarrini G, Lopez-Sanroman A, Link A, de Groot P, de Vos WM, Hogenauer C, Malfertheiner P, Mattila E, Milosavljevic T, Nieuwdorp M, Sanguinetti M, Simren M, Gasbarrini A; European FMT Working Group. European consensus conference on faecal microbiota transplantation in clinical practice. Gut. 2017 Apr;66(4):569-580. doi: 10.1136/gutjnl-2016-313017. Epub 2017 Jan 13.

  PMID: 28087657 BACKGROUND

• Translating Microbiome Research into Therapies: The Path Ahead. Cell. 2020 Apr 2;181(1):20-21. doi: 10.1016/j.cell.2020.03.009. No abstract available.

  PMID: 32243790 BACKGROUND

• Fan L, Chen J, Zhang Q, Ren J, Chen Y, Yang J, Wang L, Guo Z, Bu P, Zhu B, Zhao Y, Wang Y, Liu X, Wang W, Chen Z, Gao Q, Zheng L, Cai J. Fecal microbiota transplantation for hypertension: an exploratory, multicenter, randomized, blinded, placebo-controlled trial. Microbiome. 2025 May 23;13(1):133. doi: 10.1186/s40168-025-02118-6.

  PMID: 40410854 DERIVED

• Fan L, Ren J, Chen Y, Wang Y, Guo Z, Bu P, Yang J, Ma W, Zhu B, Zhao Y, Cai J. Effect of fecal microbiota transplantation on primary hypertension and the underlying mechanism of gut microbiome restoration: protocol of a randomized, blinded, placebo-controlled study. Trials. 2022 Feb 24;23(1):178. doi: 10.1186/s13063-022-06086-2.

  PMID: 35209934 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Jun Cai, MD,PhD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LUYUN FAN

CONTACT

01088392165; fuwai_fanluyun@163.com

LU WANG

CONTACT

01088392165; wanglu@fuwai.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Hypertension Center

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 28, 2020
• Study Start: March 17, 2021
• Primary Completion: February 1, 2022
• Study Completion: September 1, 2022
• Last Updated: July 16, 2021

Record last verified: 2021-07

Locations

CN (7)