Back to resultsEffect of Intensive FMT on Primary Hypertension
Primary Purpose
Hypertension
Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
FMT capsules
Placebo capsules
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring hypertension, microbiome, fecal microbiota transplantation, treatment
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- The Second Affiliated Hospital of Shantou University
- Shanxi Bethune Hospital
- The People's Hospital of Ji Xian District
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
FMT capsules
Placebo capsules
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in Office Systolic Blood Pressure (SBP)
Change in Office Systolic Blood Pressure (SBP)
Secondary Outcome Measures
Change in Office Systolic Blood Pressure (SBP)
Change in Office Systolic Blood Pressure (SBP)
Change in Office Diastolic Blood Pressure (DBP)
Change in Office Diastolic Blood Pressure (DBP)
Change in Home Systolic Blood Pressure (SBP)
Change in Home Systolic Blood Pressure (SBP)
Change in Home Diastolic Blood Pressure (DBP)
Change in Home Diastolic Blood Pressure (DBP), compared with baseline
Change in average SBP via 24-hour Ambulatory BP Monitoring
Change in average SBP via 24-hour Ambulatory BP Monitoring
Change in average DBP via 24-hour Ambulatory BP Monitoring
Change in average DBP via 24-hour Ambulatory BP Monitoring
Change in daytime SBP via 24-hour Ambulatory BP Monitoring
Change in daytime SBP via 24-hour Ambulatory BP Monitoring
Change in daytime DBP via 24-hour Ambulatory BP Monitoring
Change in daytime DBP via 24-hour Ambulatory BP Monitoring
Change in nighttime SBP via 24-hour Ambulatory BP Monitoring
Change in nighttime SBP via 24-hour Ambulatory BP Monitoring
Change in nighttime DBP via 24-hour Ambulatory BP Monitoring
Change in nighttime DBP via 24-hour Ambulatory BP Monitoring
Number of Participants with Adverse Events (AEs) as a Measure of Safety
Number of Participants with Adverse Events (AEs) as a Measure of Safety
Changes in Intestinal Microbiota Composition Pre- and Post-intervention via Metagenomic Analysis
Changes in Intestinal Microbiota Composition Pre- and Post-intervention (FMT or Placebo) via Metagenomic Analysis, stratified by:
Randomisation
Change in Office SBP
Changes in Intestinal Microbiota function revealed by KEGG pathways and KEGG Orthology (KO) Pre- and Post-intervention via Metagenomic Analysis
Changes in Intestinal Microbiota function revealed by KEGG pathways and KEGG Orthology (KO) Pre- and Post-intervention via Metagenomic Analysis, stratified by:
Randomisation
Change in Office SBP
Durability of Engraftment of Donor Microbiome Following FMT
Durability of engraftment of donor microbiome following FMT, measured by similarity comparison of intestinal microbiota composition between donor and recipient
Changes in Plasma Metabolite Composition Pre- and Post-intervention via Metabolomic Analysis
Changes in Plasma Metabolite Composition Pre- and Post-intervention (FMT or Placebo) via Metabolomic Analysis, stratified by:
Randomisation
Change in Office SBP
Change in Fasting Blood Glucose Level
Change in Fasting Blood Glucose Level
Change in blood HbA1c level
Change in blood glycosylated hemoglobin, type A1C (HbA1c) level
Change in blood lipid level
Change in Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol)
Change in Body Mass Index
Change in Body Mass Index
Full Information
NCT ID
NCT05608447
First Posted
November 1, 2022
Last Updated
November 1, 2022
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05608447
Brief Title
Effect of Intensive FMT on Primary Hypertension
Official Title
Effect and Safety of Intensive Fecal Microbiota Transplantation on Primary Hypertension: a Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
hypertension, microbiome, fecal microbiota transplantation, treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FMT capsules
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo capsules
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
FMT capsules
Intervention Description
FMT capsules containing extensively screened donor stool.
Intervention Type
Other
Intervention Name(s)
Placebo capsules
Intervention Description
Placebo capsules that do not contain donor stool or any active drug.
Primary Outcome Measure Information:
Title
Change in Office Systolic Blood Pressure (SBP)
Description
Change in Office Systolic Blood Pressure (SBP)
Time Frame
From baseline to Week 8
Secondary Outcome Measure Information:
Title
Change in Office Systolic Blood Pressure (SBP)
Description
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
Title
Change in Office Diastolic Blood Pressure (DBP)
Description
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
Title
Change in Home Systolic Blood Pressure (SBP)
Description
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
Title
Change in Home Diastolic Blood Pressure (DBP)
Description
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
Title
Change in average SBP via 24-hour Ambulatory BP Monitoring
Description
Change in average SBP via 24-hour Ambulatory BP Monitoring
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in average DBP via 24-hour Ambulatory BP Monitoring
Description
Change in average DBP via 24-hour Ambulatory BP Monitoring
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in daytime SBP via 24-hour Ambulatory BP Monitoring
Description
Change in daytime SBP via 24-hour Ambulatory BP Monitoring
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in daytime DBP via 24-hour Ambulatory BP Monitoring
Description
Change in daytime DBP via 24-hour Ambulatory BP Monitoring
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in nighttime SBP via 24-hour Ambulatory BP Monitoring
Description
Change in nighttime SBP via 24-hour Ambulatory BP Monitoring
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in nighttime DBP via 24-hour Ambulatory BP Monitoring
Description
Change in nighttime DBP via 24-hour Ambulatory BP Monitoring
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Number of Participants with Adverse Events (AEs) as a Measure of Safety
Description
Number of Participants with Adverse Events (AEs) as a Measure of Safety
Time Frame
All AEs over 12 weeks
Title
Changes in Intestinal Microbiota Composition Pre- and Post-intervention via Metagenomic Analysis
Description
Changes in Intestinal Microbiota Composition Pre- and Post-intervention (FMT or Placebo) via Metagenomic Analysis, stratified by:
Randomisation
Change in Office SBP
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Changes in Intestinal Microbiota function revealed by KEGG pathways and KEGG Orthology (KO) Pre- and Post-intervention via Metagenomic Analysis
Description
Changes in Intestinal Microbiota function revealed by KEGG pathways and KEGG Orthology (KO) Pre- and Post-intervention via Metagenomic Analysis, stratified by:
Randomisation
Change in Office SBP
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Durability of Engraftment of Donor Microbiome Following FMT
Description
Durability of engraftment of donor microbiome following FMT, measured by similarity comparison of intestinal microbiota composition between donor and recipient
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Changes in Plasma Metabolite Composition Pre- and Post-intervention via Metabolomic Analysis
Description
Changes in Plasma Metabolite Composition Pre- and Post-intervention (FMT or Placebo) via Metabolomic Analysis, stratified by:
Randomisation
Change in Office SBP
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in Fasting Blood Glucose Level
Description
Change in Fasting Blood Glucose Level
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in blood HbA1c level
Description
Change in blood glycosylated hemoglobin, type A1C (HbA1c) level
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in blood lipid level
Description
Change in Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in Body Mass Index
Description
Change in Body Mass Index
Time Frame
Baseline, Week 4, Week 8, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Jun, MD,PhD
Phone
86-010-88392165
Email
caijun7879@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Jun, MD,PhD
Phone
86-010-60866432
Email
caijun7879@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Cai, MD,PhD
Organizational Affiliation
Fuwai Hospital, CAMS & PUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital of Shantou University
City
Shantou
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youren Chen
Facility Name
Shanxi Bethune Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Ren
Facility Name
The People's Hospital of Ji Xian District
City
Tianjin
State/Province
Tianjin
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinfeng Yang
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The collected data, study protocol, and SAP are planned to be shared after the study ends 2 years later (anticipated)
IPD Sharing Time Frame
after the study ends 2 years later (anticipated)
IPD Sharing Access Criteria
Access to these de-identified data will be required for written permission from the responsible investigation center and only for qualified researchers.
Citations:
PubMed Identifier
28087657
Citation
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.
Results Reference
background
PubMed Identifier
28143587
Citation
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.
Results Reference
result
PubMed Identifier
35209934
Citation
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.
Results Reference
result
Learn more about this trial
Effect of Intensive FMT on Primary Hypertension
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