- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04885959
Personalized Prevotella sp. and Butyrate Enriching Diet (PPBe) (PPBe)
November 27, 2023 updated by: Nur-Fazimah Sahran, Universiti Sains Malaysia
Personalized Prevotella sp. and Butyrate Enriching Diet for Pregnant Mother and The Risk of Infant's Food Allergy: A Randomized Controlled Trial
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
92
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: NUR-FAZIMAH SAHRAN
- Phone Number: 0136004484
- Email: nfazimah_sahran@usm.my
Study Locations
-
-
Kelantan
-
Kota Bharu, Kelantan, Malaysia, 16150
- Hospital Universiti Sains Malaysia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Usual diet
Participants are subjected to received general dietary advice from attended nurses or physician during their antenatal visits.
|
specially design dietary guidelines with biomarkers monitoring
|
Experimental: PPBe Diet
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.
|
specially design dietary guidelines with biomarkers monitoring
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal Prevotella and butyrate level during pregnancy and infants food allergy
Time Frame: 12 months
|
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
Time Frame: 12 months
|
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
Time Frame: 12 months
|
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
Time Frame: 12 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: NUR-FAZIMAH SAHRAN, Universiti Sains Malaysia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
December 30, 2024
Study Registration Dates
First Submitted
May 9, 2021
First Submitted That Met QC Criteria
May 9, 2021
First Posted (Actual)
May 13, 2021
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- USM/JEPeM/20120611
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is not a plan to make IPD available
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Food Hypersensitivity
-
University Hospital, AngersUnknown
-
University of Missouri-ColumbiaTerminated
-
Stanford UniversityNational Institute of Allergy and Infectious Diseases (NIAID); Harvard School... and other collaboratorsRecruitingHypersensitivity | Peanut Hypersensitivity | Peanut Allergy | Food Allergy | Hypersensitivity, FoodUnited States
-
University of ZurichRecruitingHypersensitivity, FoodSwitzerland
-
Ann & Robert H Lurie Children's Hospital of ChicagoNational Institute of Allergy and Infectious Diseases (NIAID)Enrolling by invitationFood Allergy Peanut | Food Allergy in InfantsUnited States
-
Assistance Publique Hopitaux De MarseilleUnknown
-
National Taiwan University HospitalUnknown
-
Clinica Universidad de Navarra, Universidad de...Completed
-
National Jewish HealthSuspendedFood Allergy in ChildrenUnited States
-
Prollergy dba Ready Set FoodObvioHealthNot yet recruitingFood Allergy in Infants