Clinical trial NCT04885959: Traditional Asian Diet and Gut Microbiome and Metabolome in Healthy Volunteers and Pregnancy on Infant's Allergy Development
Official title: The Effects of Traditional Asian Diet on Gut Microbiome and Metabolome in Healthy Volunteers and Pregnancy on Subsequent Infant's Allergy Development
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pregnancy
Food Hypersensitivity
Healthy
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The research aims to elucidate a specially-designed personalized diet based on Traditional Asian Diet and its efficacy in increasing the gut colonization of Prevotella sp. and butyrate levels in pregnant mothers and the benefits in reducing infant's food allergy development.

Detailed description: A preliminary pilot study is first will be conducted among a group of healthy volunteers. This pilot study aims to assess the feasibility of the intervention and obtain pre-eliminary data on its efficacy before proceeding to the full-scale research study. Next, in the actual trial among pregnant mothers, participants will be 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.

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.

Primary outcomes:
measure: Maternal gut microbiome composition before and after intervention
timeFrame: 20 weeks
measure: Maternal stool metabolome concentration of short chain fatty acids (SCFA) before and after intervention
timeFrame: 20 weeks
measure: Incidence of allergy development in the delivered infants and its correlation with maternal gut microbiome during pregnancy.
timeFrame: 12 months
measure: Incidence of allergy development in the delivered infants and its correlation with maternal stool metabolome during pregnancy.
timeFrame: 12 months
Secondary outcomes:
measure: Infant's gut microbiome composition at neonatal age and its correlation with allergy development
timeFrame: 12 months
measure: Infant's stool metabolome of the short-chain fatty acids (SCFA) concentration during neonatal age and its correlation with allergy development
timeFrame: 12 months
measure: Infant's immune functions and allergy development
timeFrame: 12 months
measure: Infant's gut barrier and allergy development
timeFrame: 12 months
Other outcomes:
measure: The changes on gut microbiome composition in healthy volunteers before and after 4 weeks dietary intervention.
timeFrame: 4 weeks
measure: The changes on stool metabolome of shiort chain fatty cids (SCFA) composition in healthy volunteers before and after 4 weeks dietary intervention.
timeFrame: 4 weeks
Locations:
city: Kota Bharu
country: Malaysia
facility: Hospital Universiti Sains Malaysia
state: Kelantan
Study officials:
affiliation: Universiti Sains Malaysia
name: NUR-FAZIMAH SAHRAN
role: PRINCIPAL_INVESTIGATOR
References: