Probiotics and Its Associated Factors on Aflatoxin Biomarkers

NCT03882294 | Completed DMC

• 1 other identifier: PRO001
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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

Conditions

Aflatoxicosis

Keywords

probiotics; aflatoxin biomarkers; healthy subjects; intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Changes in body mass index (kg/m^2) over 16 weeks

  From week 0 to week 16

• Changes in waist circumference (cm) over 16 weeks

  From week 0 to week 16

• Changes in physical activity level (MET-min/week) over 16 weeks

  From week 0 to week 16

• Changes in dietary intake over 16 weeks

  From week 0 to week 16

• Changes in knowledge, attitude and practice (KAP) on aflatoxin over 16 weeks

  From week 0 to week 16

Study Arms (2)

Probiotics

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Probiotics OTHER

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

Probiotics

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

Teaching Hospital Universiti Putra Malaysia

Serdang, Malaysia

Location

Related Publications (1)

• Chang WL, Akiyama T, Wang JS, Yong HY, Hassan F, Abu Saad H, Jamaluddin R, Sabran MR. Impact of Probiotic Lacticaseibacillus paracasei Strain Shirota (LcS) on Aflatoxin Exposure among Healthy Malaysian Adults: A Randomized, Double-Blind, Placebo-Controlled Intervention Study. J Nutr. 2025 Jul;155(7):2110-2121. doi: 10.1016/j.tjnut.2025.04.014. Epub 2025 Apr 16.

  PMID: 40250564 DERIVED

MeSH Terms

Conditions

Aflatoxin Poisoning

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Mycotoxicosis; Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Assoc Prof Dr Rosita Jamaluddin

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized , double-blind, placebo-controlled, parallel trial

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 20, 2019
• Study Start: September 11, 2020
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)