Probiotics and Its Associated Factors on Aflatoxin Biomarkers

University of Putra Malaysia (UPM)

Status: Completed

Conditions: Aflatoxicosis

Treatments: Other: Placebo; Other: Probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT03882294

PRO001

Details and patient eligibility

About

The study will be aimed to investigate the effect of probiotic intervention and its associated factors on aflatoxin biomarkers among healthy subjects in Serdang and Kajang, Selangor

Full description

The study will be a randomized, double-blind, placebo-controlled, parallel intervention that conducted for 12 weeks and followed-up for 4 weeks among healthy adults under living condition in Serdang and Kajang, Selangor. 164 subjects will be recruited for the intervention study, where 82 subjects will be randomly allocated to the probiotic or placebo group. Probiotic and placebo drinks (80 ml) will be prepared in the form of bottle. Placebo drink will have similar taste, colour, physical appearance, and nutritional value as probiotic drink but contain no LcS. Morning urine samples (15 ml), weight status, and dietary intake will be collected every two weeks from week 0 to week 12 and follow up until week 16 at community centre. Whereas, fasting blood samples (5 ml) and physical activity will be collected every four weeks for 16 weeks at the community centre.

Enrollment: 164 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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164 participants in 2 patient groups, including a placebo group

Probiotics

Experimental group

Description:

Subjects in probiotic group will receive fermented milk containing live cultures Lactobacillus casei Shirota (LcS), 3 x 10\^10 CFU/bottle (80 ml)

Treatment:

Other: Probiotics

Placebo

Placebo Comparator group

Description:

Subjects in placebo group will receive milk drink without LcS (80 ml).

Treatment:

Other: Placebo