Clinical trial NCT03882294: Probiotics and Its Associated Factors on Aflatoxin Biomarkers
Official title: Effect of Probiotics and Its Associated Factors on Aflatoxin Biomarkers Among Healthy Subjects in Serdang and Kajang, Selangor: A Twelve-week Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aflatoxicosis
Keywords: probiotics
aflatoxin biomarkers
healthy subjects
intervention
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 164
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized , double-blind, placebo-controlled, parallel trial
Primary purpose: PREVENTION

Brief summary: 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

Detailed 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.

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

Primary outcomes:
measure: Changes in serum AFB1-lysine adducts (pg/mg albumin) over 16 weeks
timeFrame: From week 0 to week 16
measure: Changes in urinary AFM1 (ng/ml) over 16 weeks
timeFrame: From week 0 to week 16
Secondary outcomes:
measure: Changes in body mass index (kg/m^2) over 16 weeks
timeFrame: From week 0 to week 16
measure: Changes in waist circumference (cm) over 16 weeks
timeFrame: From week 0 to week 16
measure: Changes in physical activity level (MET-min/week) over 16 weeks
timeFrame: From week 0 to week 16
measure: Changes in dietary intake over 16 weeks
timeFrame: From week 0 to week 16
measure: Changes in knowledge, attitude and practice (KAP) on aflatoxin over 16 weeks
timeFrame: From week 0 to week 16
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: Teaching Hospital Universiti Putra Malaysia
Study officials:
affiliation: Universiti Putra Malaysia
name: Assoc Prof Dr Rosita Jamaluddin
role: PRINCIPAL_INVESTIGATOR
References: