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:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT03882294
Eligibility Criteria:
Inclusion Criteria:
* Malaysian healthy male or female adults (BMI \<30kg/m2) aged 20 to 60 years who have regular bowel movement (at least 4 times/week), AFB1 \>4.71 pg/mg albumin, and AFM1 \> 0.88 ng/ml
Exclusion Criteria:
1. History or presence of any clinically important disease or disorder (eg. cardiovascular disease, kidney disease, diabetes mellitus, etc.) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
2. Mental status that is incompatible with the proper conduct of the study
3. Functional constipation \[based on Rome III diagnostic criteria with a five-point symptoms based diagnosing tool (0=never or rarely, 1=sometimes, 2=often, 3=most of the time, 4=always)\]
4. Diarrhoea within 2 months prior to the study start
5. Allergic reaction towards probiotic, milk and with gastric problem
6. Lactose intolerance
7. Use of medications or/and antibiotics
8. Use of probiotic, prebiotic and fibre supplements or/and laxatives during the two weeks prior to study start.
9. Drug/alcohol abuse (for alcohol 4 times/day or 20 times/week)
10. Pregnant
11. Reported special diets such as vegetarian, vegan, or macrobiotic
12. Festive (eg. Ramadan, Chinese New Year etc) 3 months before and during the study
13. Participation in another intervention study one month prior to the present study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT03882294
Study Brief:
Protocol Section:
NCT03882294