Probiotics and Its Associated Factors on Aflatoxin Biomarkers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-11

Study Completion Date

2021-10-31

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

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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.

Conditions

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Aflatoxicosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized , double-blind, placebo-controlled, parallel trial

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Participants, care provider, and investigators will be blinded for the treatment assignment. A controller will be recruited to determine the two groups into probiotic and placebo groups.

Study Groups

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Probiotics

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

Group Type EXPERIMENTAL

Probiotics

Intervention Type OTHER

Participants will be requested to consume the drinks (80 ml) twice a day - after lunch and dinner for 12 weeks.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Participants will be requested to consume the drinks (80 ml) twice a day - after lunch and dinner for 12 weeks.

Interventions

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Probiotics

Participants will be requested to consume the drinks (80 ml) twice a day - after lunch and dinner for 12 weeks.

Intervention Type OTHER

Placebo

Participants will be requested to consume the drinks (80 ml) twice a day - after lunch and dinner for 12 weeks.

Intervention Type OTHER

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

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes