Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT04885959
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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04885959
Study Brief:
Protocol Section:
NCT04885959