Effect of Intensive FMT on Primary Hypertension

NCT05608447 | Unknown Phase 1 DMC

• 1 other identifier: 2017-GZ10 (Part III)
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Hypertension

Keywords

hypertension; microbiome; fecal microbiota transplantation; treatment

Outcome Measures

Primary Outcomes (1)

• Change in Office Systolic Blood Pressure (SBP)

  Change in Office Systolic Blood Pressure (SBP)

  From baseline to Week 8

Secondary Outcomes (19)

• Change in Office Systolic Blood Pressure (SBP)

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 12

• Change in Office Diastolic Blood Pressure (DBP)

  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)

  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)

  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

  Baseline, Week 4, Week 8, Week 12

Study Arms (2)

FMT capsules

ACTIVE COMPARATOR

FMT capsules containing extensively screened donor stool. FMT capsules will be orally taken on Day 0 (randomization), Day 1, Day 2, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49.

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 Day 0 (randomization), Day 1, Day 2, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49.

Other: Placebo capsules

Interventions

FMT capsules BIOLOGICAL

FMT capsules containing extensively screened donor stool.

FMT capsules

Placebo capsules OTHER

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

Placebo capsules

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18\~65 years.
• 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".
• 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

Study Sites (3)

The Second Affiliated Hospital of Shantou University

Shantou, Guangdong, China

Location

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Location

The People's Hospital of Ji Xian District

Tianjin, Tianjin Municipality, China

Location

Related Publications (3)

• 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

• 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 RESULT

• 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 RESULT

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

Jun Jun, MD,PhD

CONTACT

86-010-88392165; caijun7879@126.com

Jun Jun, MD,PhD

CONTACT

86-010-60866432; caijun7879@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Doctoral supervisor, Assistant Principal of Fuwai Hospital, Chief of Hypertension Center, Fuwai Hospital,PUMC&CAMS

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: January 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: September 30, 2023
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after the study ends 2 years later (anticipated)
• Access Criteria: Access to these de-identified data will be required for written permission from the responsible investigation center and only for qualified researchers.

Locations

CN (3)