HypertensionEarly Phase 1FMTNCT04406129
Effect of Gut Microbiome Restoration on Primary Hypertension Via FMT
A Early Phase 1 study testing FMT capsules in people with Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 7 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypertension
- What is being tested?
- FMT capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 7 sitesChina
- Study dates
- 17 Mar 2021to 1 Sep 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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])
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Not yet recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037
Jun Cai
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Peili Bu
- Recruiting
Fuwai Yunnan Cardiovascular Hospital
Kunming, Yunnan
Zihong Guo
- Recruiting
The Second Affiliated Hospital of Shantou University
Shantou, Guangdong
Youren Chen
- Recruiting
Southern University of Science and Technology Hospital
Shenzhen, Shenzhen
Bingpo Zhu
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi
Jie Ren
- Not yet recruiting
The People's Hospital of Ji Xian District
Tianjin, Tianjin Municipality
Jinfeng Yang
About this study
Official title: Effect of Fecal Microbiota Transplantation on Primary Hypertension and the Underlying Mechanism of Gut Microbiome Restoration: a Randomized Clinical Trial
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.
Read the 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 of metagenomics analysis, fecal transplantation and metabolomics changes in hypertension and pre-hypertension patients, a casual role of gut microbiome disorder was observed in primary hypertension and raised a hypothesis that gut microbiome restoration can be a potential approach to ameliorate hypertension. Recent studies indicated FMT, prebiotics, probiotics, dietary changes and other methodologies can assist gut microbiome restoration in diseases such as type 2 diabetes. The investigators therefore develop two pilot studies respectively utilizing FMT capsules (Pilot Study I) and innovative dietary changes (Pilot Study II) to explore the effect, safety and underlying mechanisms of gut microbiome restoration on hypertension. These pilot studies also present as the clinical translational section of the research project "The Role of Gut Microbiome in the Pathogenesis of Essential Hypertension"(Project ID 81630014, sponsored by National Natural Science Foundation of China).
This study is the Study I:
Objective: To explore the effect, safety and underlying mechanisms of gut microbiome restoration via FMT on primary hypertension.
Study Design: A multicenter, randomized, double-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.
Ethics: The Ethics Committee of Fuwai Hospital approved this study. Informed consents before patient enrollment are required.
- Conditions
- Hypertension
- Being tested
- FMT capsules, Placebo capsules
- Keywords
- Hypertension, Microbiome, Treatment, Fecal Microbiota Transplantation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMT capsulesBiological
Intervention: FMT capsules containing extensively screened donor stool.
Placebo capsulesOther
Intervention: Placebo capsules that do not contain donor stool or any active drug.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change for Office Systolic Blood Pressure (SBP)
Change for Office Systolic Blood Pressure (SBP)
Measured: From baseline to Day 30
Secondary outcomes (20)
Change for Office SBP
Change for Office SDBP
Measured: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
Change for Office Diastolic Blood Pressure (DBP)
Change for Office Diastolic Blood Pressure (DBP)
Measured: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
Change for Home Systolic Blood Pressure (SBP)
Change for Home Systolic Blood Pressure (SBP)
Measured: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
Change for Home Diastolic Blood Pressure (DBP)
Change for Home Diastolic Blood Pressure (DBP)
Measured: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
Change for average SBP via 24-hour Ambulatory BP Monitoring
Change for average SBP via 24-hour Ambulatory BP Monitoring
Measured: Baseline, Day 30, Day 90
Change for average DBP via 24-hour Ambulatory BP Monitoring
Change for average DBP via 24-hour Ambulatory BP Monitoring
Measured: Baseline, Day 30, Day 90
Change for daytime average SBP via 24-hour Ambulatory BP Monitoring
Change for daytime average SBP via 24-hour Ambulatory BP Monitoring
Measured: Baseline, Day 30, Day 90
Change for daytime average DBP via 24-hour Ambulatory BP Monitoring
Change for daytime average DBP via 24-hour Ambulatory BP Monitoring
Measured: Baseline, Day 30, Day 90
Change for nightime average SBP via 24-hour Ambulatory BP Monitoring
Change for nightime average SBP via 24-hour Ambulatory BP Monitoring
Measured: Baseline, Day 30, Day 90
Change for nightime average DBP via 24-hour Ambulatory BP Monitoring
Change for nightime average DBP via 24-hour Ambulatory BP Monitoring
Measured: Baseline, Day 30, Day 90
Change for Ankle-Brachial Blood Pressure Index(ABI)
Change for ABI as an objective measurement of arterial insufficiency based on the ratio of ankle systolic pressure to brachial systolic pressure.
Measured: Baseline, Day 90
Number of Participants with Adverse Events (AEs) as a Measure of Safety
Number of Participants with Adverse Events (AEs) as a Measure of Safety
Measured: All AEs over 3 months
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
Measured: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
Changes in Intestinal Microbiota Function Pre- and Post-intervention via Metagenomic Analysis
Changes in Intestinal Microbiota Function Pre- and Post-intervention (FMT or Placebo) via Metagenomic Analysis, stratified by:
- Randomisation
- Change in Office SBP
Measured: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
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
Measured: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
Changes in Intestinal Metabolite Composition Pre- and Post-intervention via Metabolomic Analysis
Changes in Intestinal Metabolite Composition Pre- and Post-intervention (FMT or Placebo) via Metabolomic Analysis, stratified by:
- Randomisation
- Change in Office SBP
Measured: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
Changes in Serum Metabolite Composition Pre- and Post-intervention via Metabolomic Analysis
Changes in Serum Metabolite Composition Pre- and Post-intervention (FMT or Placebo) via Metabolomic Analysis, stratified by:
- Randomisation
- Change in Office SBP
Measured: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
Change for Fasting Blood Glucose Level
Change for Fasting Blood Glucose Level
Measured: Baseline, Day 90
Change for Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol)
Change for Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol)
Measured: Baseline, Day 90
Change for Body Mass Index
Change for Body Mass Index
Measured: Baseline, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start17 Mar 2021
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Jun Cai, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Jun Cai, MD,PhD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406129
- Sponsor's protocol ID
- 2017-GZ10 (Part I)
- Acronym
- FMT
- Status last verified
- Jul 2021
- First submitted
- 20 May 2020
- Last updated
- 16 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28143587Cammarota 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.
PubMed 28087657Translating 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.
PubMed 32243790Fan 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.
PubMed 40410854Fan 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.
PubMed 35209934
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fecal Microbiota Transplantation on Primary Hypertension and the Underlying Mechanism of Gut Microbiome Restoration: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04406129
- Acronym / sponsor ID
- FMT / 2017-GZ10 (Part I)
- Conditions
- Hypertension
- Keywords
- Hypertension, Microbiome, Treatment, Fecal Microbiota Transplantation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 of metagenomics analysis, fecal transplantation and metabolomics changes in hypertension and pre-hypertension patients, a casual role of gut microbiome disorder was observed in primary hypertension and raised a hypothesis that gut microbiome restoration can be a potential approach to ameliorate hypertension. Recent studies indicated FMT, prebiotics, probiotics, dietary changes and other methodologies can assist gut microbiome restoration in diseases such as type 2 diabetes. The investigators therefore develop two pilot studies respectively utilizing FMT capsules (Pilot Study I) and innovative dietary changes (Pilot Study II) to explore the effect, safety and underlying mechanisms of gut microbiome restoration on hypertension. These pilot studies also present as the clinical translational section of the research project "The Role of Gut Microbiome in the Pathogenesis of Essential Hypertension"(Project ID 81630014, sponsored by National Natural Science Foundation of China).
This study is the Study I:
Objective: To explore the effect, safety and underlying mechanisms of gut microbiome restoration via FMT on primary hypertension.
Study Design: A multicenter, randomized, double-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.
Ethics: The Ethics Committee of Fuwai Hospital approved this study. Informed consents before patient enrollment are required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMT capsules | Experimental | Biological: FMT capsulesIntervention: 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). |
| Placebo capsules | Placebo comparator | Other: Placebo capsulesIntervention: 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FMT capsulesIntervention: FMT capsules containing extensively screened donor stool. | Biological | FMT capsules |
| Placebo capsulesIntervention: Placebo capsules that do not contain donor stool or any active drug. | Other | Placebo capsules |
Primary outcome
Change for Office Systolic Blood Pressure (SBP)
Time frame: From baseline to Day 30
Change for Office Systolic Blood Pressure (SBP)
20 secondary outcomes
Change for Office SBP
Time frame: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
Change for Office Diastolic Blood Pressure (DBP)
Time frame: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
Change for Home Systolic Blood Pressure (SBP)
Time frame: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
Change for Home Diastolic Blood Pressure (DBP)
Time frame: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
Change for average SBP via 24-hour Ambulatory BP Monitoring
Time frame: Baseline, Day 30, Day 90
Change for average DBP via 24-hour Ambulatory BP Monitoring
Time frame: Baseline, Day 30, Day 90
Change for daytime average SBP via 24-hour Ambulatory BP Monitoring
Time frame: Baseline, Day 30, Day 90
Change for daytime average DBP via 24-hour Ambulatory BP Monitoring
Time frame: Baseline, Day 30, Day 90
Change for nightime average SBP via 24-hour Ambulatory BP Monitoring
Time frame: Baseline, Day 30, Day 90
Change for nightime average DBP via 24-hour Ambulatory BP Monitoring
Time frame: Baseline, Day 30, Day 90
Change for Ankle-Brachial Blood Pressure Index(ABI)
Time frame: Baseline, Day 90
Number of Participants with Adverse Events (AEs) as a Measure of Safety
Time frame: All AEs over 3 months
Changes in Intestinal Microbiota Composition Pre- and Post-intervention via Metagenomic Analysis
Time frame: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
Changes in Intestinal Microbiota Function Pre- and Post-intervention via Metagenomic Analysis
Time frame: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
Durability of Engraftment of Donor Microbiome Following FMT
Time frame: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
Changes in Intestinal Metabolite Composition Pre- and Post-intervention via Metabolomic Analysis
Time frame: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
Changes in Serum Metabolite Composition Pre- and Post-intervention via Metabolomic Analysis
Time frame: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
Change for Fasting Blood Glucose Level
Time frame: Baseline, Day 90
Change for Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol)
Time frame: Baseline, Day 90
Change for Body Mass Index
Time frame: Baseline, Day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Background: PubMed 28143587Li 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.
- Background: PubMed 28087657Cammarota 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.
- Background: PubMed 32243790Translating 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.
- Derived from this study: PubMed 40410854Fan 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.
- Derived from this study: PubMed 35209934Fan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Cai, MD,PhD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing FMT capsules in people with Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LUYUN FAN (01088392165, fuwai_fanluyun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change for Office Systolic Blood Pressure (SBP) (time frame: From baseline to Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04406129, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.