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

Overview

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.

Interventions

• Behavioral Traditional Asian Diet
  The personalized traditional Asian diet will be formulated based on dietary components of a typical Asian diet characterized by high intake of fruits and vegetables, whole grains, legumes, nuts, seeds, soy foods and herbs and spices; moderate intake of fish, poultry, eggs, healthy cooking oils, yogurt or functional foods and low intake of meats and sweets (Ismail et al., 2020). The diet design also considering the recommendation of personalized dietary approach by including the element of indivi

Primary outcome measures

• Maternal gut microbiome composition before and after intervention [Time frame: 20 weeks]
• Maternal stool metabolome concentration of short chain fatty acids (SCFA) before and after intervention [Time frame: 20 weeks]
• Incidence of allergy development in the delivered infants and its correlation with maternal gut microbiome during pregnancy. [Time frame: 12 months]
• Incidence of allergy development in the delivered infants and its correlation with maternal stool metabolome during pregnancy. [Time frame: 12 months]

Secondary outcome measures (4)

• Infant's gut microbiome composition at neonatal age and its correlation with allergy development [Time frame: 12 months]
• Infant's stool metabolome of the short-chain fatty acids (SCFA) concentration during neonatal age and its correlation with allergy development [Time frame: 12 months]
• Infant's immune functions and allergy development [Time frame: 12 months]
• Infant's gut barrier and allergy development [Time frame: 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

Malaysia · 1 center

• Hospital Universiti Sains Malaysia — Kota Bharu

Publications

• Sahran NF, Chong CW, Ismail IH, Taib F, Hoo PS, Palanisamy UD, Sundralingam U, Teh CSJ, Kong ZX, Ayub Q, Yoke Ling F, Hazlan SNH, Azlan M, Abdul Razak S, Tengku Din TADA, Abdullah N, Tagiling N, Tee V, Ehab Ayad M, Zheng FM, El-Omar E, Lee YY. Effects of Traditional Asian Diet on dietary fibre requirement, gut microbiome composition, and faecal and urine metabolomes in healthy Asian women: a pilot PMID 40312033

Identifiers

NCT: NCT04885959 · USM/JEPeM/20120611

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗