Probiotics and Its Associated Factors on Aflatoxin Biomarkers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Probiotics and Its Associated Factors on Aflatoxin Biomarkers Among Healthy Subjects in Serdang and Kajang, Selangor: A Twelve-week Intervention

Conditions
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Aflatoxicosis

Intervention / Treatment
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* Other: Probiotics
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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: 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 Mental status that is incompatible with the proper conduct of the study 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)] Diarrhoea within 2 months prior to the study start Allergic reaction towards probiotic, milk and with gastric problem Lactose intolerance Use of medications or/and antibiotics Use of probiotic, prebiotic and fibre supplements or/and laxatives during the two weeks prior to study start. Drug/alcohol abuse (for alcohol 4 times/day or 20 times/week) Pregnant Reported special diets such as vegetarian, vegan, or macrobiotic Festive (eg. Ramadan, Chinese New Year etc) 3 months before and during the study Participation in another intervention study one month prior to the present study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized , double-blind, placebo-controlled, parallel trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>Subjects in probiotic group will receive fermented milk containing live cultures Lactobacillus casei Shirota (LcS), 3 x 10^10 CFU/bottle (80 ml) | Other: Probiotics<br>* Participants will be requested to consume the drinks (80 ml) twice a day - after lunch and dinner for 12 weeks.<br>|
| Placebo Comparator: Placebo<br>Subjects in placebo group will receive milk drink without LcS (80 ml). | Other: Placebo<br>* Participants will be requested to consume the drinks (80 ml) twice a day - after lunch and dinner for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum AFB1-lysine adducts (pg/mg albumin) over 16 weeks | Analysis of serum AFB1-lysine adducts will be done using elisa kit through HPLC. | From week 0 to week 16 | 
| Changes in urinary AFM1 (ng/ml) over 16 weeks | Analysis of urinary AFM1 will be done using elisa kit. | From week 0 to week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body mass index (kg/m^2) over 16 weeks | Changes in weight and height will be measured using weighing scale and body meter respectively. Weight and height will be combined to report BMI in kg/m^2 | From week 0 to week 16 | 
| Changes in waist circumference (cm) over 16 weeks | The parameter will be measured using measuring tape. | From week 0 to week 16 | 
| Changes in physical activity level (MET-min/week) over 16 weeks | The parameter will be examined using questionnaire based on the Global Physical Activity Questionnaire. | From week 0 to week 16 | 
| Changes in dietary intake over 16 weeks | Dietary assessment will be recorded via food frequency questionnaire (FFQ). The conversion of food frequency to the amount of food intake is carried out using the following formula: Amount of food (g/day) = frequency of intake (conversion factor) × serving size × total of serving × weight of food in one serving (Wessex Institute of Public Health, 1995). | From week 0 to week 16 | 
| Changes in knowledge, attitude and practice (KAP) on aflatoxin over 16 weeks | KAP will be examined using questionnaire in bilingual (English and Bahasa Malaysia). Knowledge towards aflatoxin is scored into two groups: know and do not know. Attitudes and practices are categorized using likert scale with 1=strongly disagree, 2=disagree, 3=agree and 4=strongly agree. | From week 0 to week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics, aflatoxin biomarkers, healthy subjects, intervention