Status:
UNKNOWN
Evaluation of Intestinal Microbiota Manipulation to Treat Resistant Hypertension
Lead Sponsor:
Hospital de Base
Collaborating Sponsors:
Sao Jose do Rio Preto Medical School
Conditions:
Hypertension
Resistant Hypertension
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief Summary
The gastrointestinal tract begins its colonization shortly after birth. During the first two years of life, gut microbiota is unstable and less diverse than in adulthood. Its complexity and diversity ...
Detailed Description
The gastrointestinal tract begins its colonization shortly after the birth. During the first two years of life, microbiota is unstable and less diverse than in adulthood, when its complexity and diver...
Eligibility Criteria
Inclusion
- Be normotensive, controlled hypertensive or resistant hypertensive.
- Body Mass Index (BMI) \< 35 kg/m 2 .
- If diabetic, glycated hemoglobin must be ≤ 9.0%.
- Agree and sign the Free Informed Consent Form (FICF).
Exclusion
- BMI ≥ 35 kg/m 2 ;
- Urinary Sodium ≥ 200mEq/L in 24-hour urine;
- Bariatric Surgery;
- Recent use of antibiotics or probiotics (\<3 months);
- Prior Cardiovascular Disease: Acute Myocardial Infarction, Stroke, Heart Failure, Angina Pectoris, Peripheral Arterial Insufficiency;
- Chronic kidney disease (glomerular filtration rate (GFR) \< 30 mL/min/m 2 );
- Chronic Disease limiting participation at the study or life expectancy (e.g.: cancer, among others);
- Gastrointestinal diseases (including inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis or other disabsortive disease)
- Pregnant or having the intension of become pregnant in the next two years;
- Participation in any other clinical studies in the past six months.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04398693
Start Date
February 1 2019
End Date
January 1 2022
Last Update
February 25 2021
Active Locations (1)
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1
State Medical School at São José do Rio Preto (FAMERP), São Paulo, Brazil
São José do Rio Preto, São Paulo, Brazil, 15090-000