NCT04406129

Effect of Gut Microbiome Restoration on Primary Hypertension Via FMT

Effect of Fecal Microbiota Transplantation on Primary Hypertension and the Underlying Mechanism of Gut Microbiome Restoration: a Randomized Clinical Trial

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
BIOLOGICAL	FMT capsules	Intervention: FMT capsules containing extensively screened donor stool.
OTHER	Placebo capsules	Intervention: Placebo capsules that do not contain donor stool or any active drug.

Timeline

• Start date: 2021-03-17
• Primary completion: 2022-02-01
• Completion: 2022-09-01
• First posted: 2020-05-28
• Last updated: 2021-07-16

Locations

7 sites across 1 country: China