Status:
COMPLETED
Brain Probiotic and LC-PUFA Intervention for Optimum Early Life
Lead Sponsor:
Indonesia University
Collaborating Sponsors:
Grand Challenges Canada
Conditions:
Maternal Exposure
Health Behavior
Eligibility:
FEMALE
20-40 years
Phase:
PHASE2
Brief Summary
Probiotics is suggested to play several roles in promoting health, including alleviating disease symptoms, protection against atopic disease, and modulating the immune system by improving the benefici...
Detailed Description
Health and well-being at all ages is one of the goal set in the Sustainable Development Goals. Starting as early as possible has been considered to be an effective strategy for better investation in a...
Eligibility Criteria
Inclusion
- Each pregnant woman must meet all of the following criteria to be enrolled in this study:
- 1\. Indonesian pregnant women in the 2nd trimester of gestational period 2. healthy pregnancy (as measured by hemoglobin level, pregnancy status, pregnancy history) 3. Having a normal blood pressure 4. Planning to stay in the study area until the child is 6 months old 5. Willing to sign informed consent 5. Having a legally acceptable representative who is capable to understand the informed consent document and providing consent on the subject's behalf
Exclusion
- Each pregnant women meeting any of the following criteria will be excluded from the study:
- Having foreign objects in the body due to trauma, artificial heart value, metal objects or ferromagnetic (plate, screw, clip, prosthetic), and electronic device (pacemaker, cochlear implant, insulin pump), and being claustrophobic
- Having history of previous gestational diabetes or been diagnosed to have gestational diabetes
- Having history of type 1 and type 2 diabetes
- Severe anemia
- Inclusion Criteria for Follow-up at 24 months:
- Child age above 24 months from the BRAVE intervention project
- Having a legally acceptable representative who is capable to understand the informed consent document and providing consent on the subject's behalf
- Exclusion Criteria for Follow-up at 24 months:
- 1\. Child being hospitalized during the study/data collection
Key Trial Info
Start Date :
October 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT03851120
Start Date
October 31 2019
End Date
August 31 2024
Last Update
August 29 2025
Active Locations (1)
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1
Human Nutrition Research Center, Indonesian Medical Education Research Institute; and Department of Nutrition, Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, DKI Jakarta, Indonesia, 13420