Personalized Prevotella sp. and Butyrate Enriching Diet (PPBe)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Food Hypersensitivity
- Pregnancy
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 40 years
- Gender
- Only males
Description
After being informed about the study and potential risk, all patients giving written informed consent will go one week screening period to assess for study eligibility prior to enrollment. At week 0, single-blind randomization (subject and health care providers except for principal investigator) wil...
After being informed about the study and potential risk, all patients giving written informed consent will go one week screening period to assess for study eligibility prior to enrollment. At week 0, single-blind randomization (subject and health care providers except for principal investigator) will be conducted and participant will be randomized into two groups namely; the control group and the intervention group. The control group will receive standard dietary counselling on a healthy pregnancy diet. Meanwhile, the intervention group will receive dietary intervention which is tailored to the study objective to increase targeted bacteria of Prevotella sp and the short-chain fatty acids namely butyrate. The trial will be in 20 weeks duration during pregnancy and additional 12-months follow up for the delivered infants.
Tracking Information
- NCT #
- NCT04885959
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: NUR-FAZIMAH SAHRAN Universiti Sains Malaysia
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