Clinical Trial Finder

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.

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.

Arms

No Intervention: Usual diet

In the pilot study among healthy volunteers, participant need to maintain their habitual diet for 4 weeks. Meanwhile, in the large-scale study among pregnant women, participants are subjected to receive general dietary advice for healthy pregnancy from attended nurses or physician during their antenatal visits.

Experimental: Traditional Asian Diet

Participants will receive dietary intervention on a traditional Asian diet which diet consists of high fiber, moderate protein, and low fat and with the inclusion of local probiotics and prebiotics food sources which are known to enhance gut health by fostering the gut colonization of beneficial bacteria and promoting the production of SCFA. During the pilot phase the diet is given for four weeks. Meanwhile, the intervention among pregnant mothers, the intervention is given for 20 weeks considering the nature of the availability of pregnant mothers being recruited where most of them (low risk pregnancy) were given their first clinic appointment at 16 weeks of gestational age.

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 individual preferences, requirement, cultural preferences, affordability and foods availability to facilitate the adherence and response to the diet.