Personalized Prevotella sp. and Butyrate Enriching Diet (PPBe)

Study Overview
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Brief Summary
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The research aims to elucidate a specially-designed personalized diet that will increase gut colonization of Prevotella sp. and butyrate levels in pregnant mothers and the benefits in reducing infant's food allergy development.

Detailed Description
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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.

Official Title
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Personalized Prevotella sp. and Butyrate Enriching Diet for Pregnant Mother and The Risk of Infant's Food Allergy: A Randomized Controlled Trial

Conditions
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Pregnancy, Food Hypersensitivity

Intervention / Treatment
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* Behavioral: Personalized Prevotella sp. and butyrate enriching diet guidelines


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Malaysian and of the Malay ethnicity Living in Kelantan for at least 5 years Age 18 to 40 years The lower limit of ≥16th weeks and the upper limit of <20th week of gestation during enrollment to allow at least 20 weeks of dietary intervention prior to delivery. The gestational age was based on the last menstrual period (LMP) or early ultrasound examination Singleton pregnancy History of personal and family history of allergy (presence of reported or doctor-diagnosed allergic disease including asthma, eczema, food allergy, or allergy rhinitis) in participants, their partners or in their previous child or pregnancy. In attendance of antenatal clinic at Hospital USM or Klinik Kesihatan (Kota Bharu/Kubang Kerian/Pengkalan Chepa) Living area within 10 km radius of Kota Bharu, Kelantan Consent to participate Exclusion Criteria: Significant present or having past medical history of chronic disease for example bowel, cancer disease, systemic lupus erythematosus (SLE), chronic kidney disease, heart failure, stroke, haematological malignancy, and chronic obstructive pulmonary disease. Significant psychiatric history including major depression and other psychotic disorders. Significant present or past surgical history including bowel surgeries Significant presence of doctor-diagnosed short intestinal bacteria overgrowth (SIBO). Taking any medications which may disturb the gut microbiota or intestinal function, for example, antibiotics for the past 3 months, immunosuppressive drugs, opiates, anticoagulants and etc. Those who plan to move out from Kelantan after delivery which may affect the follow-up. Those who follow a vegetarian diet will also be excluded from participating.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Usual diet<br>Participants are subjected to received general dietary advice from attended nurses or physician during their antenatal visits. | Behavioral: Personalized Prevotella sp. and butyrate enriching diet guidelines<br>* specially design dietary guidelines with biomarkers monitoring<br>|
| Experimental: PPBe Diet<br>Participants 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. | Behavioral: Personalized Prevotella sp. and butyrate enriching diet guidelines<br>* specially design dietary guidelines with biomarkers monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Prevotella and butyrate level during pregnancy and infants food allergy | Maternal Prevotella and butyrate level will be compared between groups and correlate with the incidence of infant's food allergy at 12 months of age. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant's gut microbiota and butyrate level and infant's food allergy | Infant's early gut microbiota and butyrate level on day-7 dan 3-month will be correlate with the incidence of food's allergy at 12-months | 12 months | 
| Immune function, gut barrier and infant's food allergy development | Infant's immune function (measured by interleukin-10/IL-10, and transforming growth factor-beta/TGF-B) and gut barrier (intestinal fatty acid binding protein/I-FABP) will be measured at 12-months of ages and further correlate with infant's gut microbiota and butyrate level to investigate the underlying mechanism that could explain food allergy development. | 12 months | 
| Maternal gut microbiota and butyrate level during pregnancy and infant's immune function and gut barrier development | Infant's immune function (measured by interleukin-10/IL-10, and transforming growth factor-beta/TGF-B) and gut barrier (intestinal fatty acid binding protein/I-FABP) will be measured at 12-months of ages and further correlate with maternal gut microbiota and butyrate level during pregnancy to investigate the underlying mechanism that could explain food allergy development | 12 months |