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.

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.

Arms

Placebo Comparator: Usual diet

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

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.

Interventions

Behavioral: - Personalized Prevotella sp. and butyrate enriching diet guidelines

specially design dietary guidelines with biomarkers monitoring