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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was observed after short-course FMT intervention but recovery after intervention termination(Trials. 2022;23(1):178, unpublished results).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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMT capsules | Biological | FMT capsules containing extensively screened donor stool. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Office Systolic Blood Pressure (SBP) | Change in Office Systolic Blood Pressure (SBP) | From baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Office Systolic Blood Pressure (SBP) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Jun, MD,PhD | Contact | 86-010-88392165 | caijun7879@126.com | |
| Jun Jun, MD,PhD | Contact | 86-010-60866432 | caijun7879@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Cai, MD,PhD | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Shantou University | Shantou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28087657 | 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. | |
| 28143587 |
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The collected data, study protocol, and SAP are planned to be shared after the study ends 2 years later (anticipated)
after the study ends 2 years later (anticipated)
Access to these de-identified data will be required for written permission from the responsible investigation center and only for qualified researchers.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| Placebo capsules |
| Other |
Placebo capsules that do not contain donor stool or any active drug. |
|
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) | 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) | Change in Home Diastolic Blood Pressure (DBP), compared with baseline | 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 | Change in average SBP via 24-hour Ambulatory BP Monitoring | Baseline, Week 4, Week 8, Week 12 |
| Change in average DBP via 24-hour Ambulatory BP Monitoring | Change in average DBP via 24-hour Ambulatory BP Monitoring | Baseline, Week 4, Week 8, Week 12 |
| Change in daytime SBP via 24-hour Ambulatory BP Monitoring | Change in daytime SBP via 24-hour Ambulatory BP Monitoring | Baseline, Week 4, Week 8, Week 12 |
| Change in daytime DBP via 24-hour Ambulatory BP Monitoring | Change in daytime DBP via 24-hour Ambulatory BP Monitoring | Baseline, Week 4, Week 8, Week 12 |
| Change in nighttime SBP via 24-hour Ambulatory BP Monitoring | Change in nighttime SBP via 24-hour Ambulatory BP Monitoring | Baseline, Week 4, Week 8, Week 12 |
| Change in nighttime DBP via 24-hour Ambulatory BP Monitoring | Change in nighttime DBP via 24-hour Ambulatory BP Monitoring | Baseline, Week 4, Week 8, Week 12 |
| Number of Participants with Adverse Events (AEs) as a Measure of Safety | Number of Participants with Adverse Events (AEs) as a Measure of Safety | All AEs over 12 weeks |
| 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:
| Baseline, Week 4, Week 8, Week 12 |
| 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:
| Baseline, Week 4, Week 8, Week 12 |
| 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 | Baseline, Week 4, Week 8, Week 12 |
| 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:
| Baseline, Week 4, Week 8, Week 12 |
| Change in Fasting Blood Glucose Level | Change in Fasting Blood Glucose Level | Baseline, Week 4, Week 8, Week 12 |
| Change in blood HbA1c level | Change in blood glycosylated hemoglobin, type A1C (HbA1c) level | Baseline, Week 4, Week 8, Week 12 |
| Change in blood lipid level | Change in Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol) | Baseline, Week 4, Week 8, Week 12 |
| Change in Body Mass Index | Change in Body Mass Index | Baseline, Week 4, Week 8, Week 12 |
| Shanxi Bethune Hospital | Taiyuan | Shanxi | China |
|
| The People's Hospital of Ji Xian District | Tianjin | Tianjin Municipality | China |
|
| Result |
| 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. |
| 35209934 | 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. |