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Personalized Prevotella sp. and Butyrate Enriching Diet (PPBe) (PPBe)

Primary Purpose

Pregnancy, Food Hypersensitivity

Status

Unknown status

Phase

Not Applicable

Locations

Malaysia

Study Type

Interventional

Intervention

Personalized Prevotella sp. and butyrate enriching diet guidelines

About this trial

This is an interventional prevention trial for Pregnancy

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Hospital Universiti Sains MalaysiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Usual diet

PPBe Diet

Arm Description

Participants are subjected to received general dietary advice from attended nurses or physician during their antenatal visits.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

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

Full Information

NCT ID

NCT04885959

First Posted

May 9, 2021

Last Updated

September 28, 2021

Sponsor

Universiti Sains Malaysia

1. Study Identification

Unique Protocol Identification Number

NCT04885959

Brief Title

Personalized Prevotella sp. and Butyrate Enriching Diet (PPBe)

Acronym

PPBe

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2021 (Actual)

Primary Completion Date

January 31, 2023 (Anticipated)

Study Completion Date

February 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universiti Sains Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pregnancy, Food Hypersensitivity

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Usual diet

Arm Type

Placebo Comparator

Arm Description

Participants are subjected to received general dietary advice from attended nurses or physician during their antenatal visits.

Arm Title

PPBe Diet

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Personalized Prevotella sp. and butyrate enriching diet guidelines

Intervention Description

specially design dietary guidelines with biomarkers monitoring

Primary Outcome Measure Information:

Title

Maternal Prevotella and butyrate level during pregnancy and infants food allergy

Description

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.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Infant's gut microbiota and butyrate level and infant's food allergy

Description

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

Time Frame

12 months

Title

Immune function, gut barrier and infant's food allergy development

Description

Time Frame

12 months

Title

Maternal gut microbiota and butyrate level during pregnancy and infant's immune function and gut barrier development

Description

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

Time Frame

12 months

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Pregnant women

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

NUR-FAZIMAH SAHRAN

Phone

0136004484

nfazimah_sahran@usm.my

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

NUR-FAZIMAH SAHRAN

Organizational Affiliation

Universiti Sains Malaysia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universiti Sains Malaysia

City

Kota Bharu

State/Province

Kelantan

ZIP/Postal Code

16150

Country

Malaysia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

NUR-FAZIMAH SAHRAN

Phone

0136004484

nfazimah_sahran@usm.my

First Name & Middle Initial & Last Name & Degree

Yeong Yeh Lee

yylee@usm.my

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is not a plan to make IPD available

Learn more about this trial

Personalized Prevotella sp. and Butyrate Enriching Diet (PPBe)

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