AflatoxicosisNCT03882294
Probiotics and Its Associated Factors on Aflatoxin Biomarkers
A study testing Probiotics in people with Aflatoxicosis, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Aflatoxicosis
- What is being tested?
- Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteMalaysia
- Study dates
- 11 Sep 2020to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Probiotics and Its Associated Factors on Aflatoxin Biomarkers Among Healthy Subjects in Serdang and Kajang, Selangor: A Twelve-week Intervention
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
Read the 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.
- Conditions
- Aflatoxicosis
- Being tested
- Probiotics, Placebo
- Keywords
- probiotics, aflatoxin biomarkers, healthy subjects, intervention
- Medical subject headings
- Aflatoxin Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsOther
Participants will be requested to consume the drinks (80 ml) twice a day - after lunch and dinner for 12 weeks.
PlaceboOther
Participants will be requested to consume the drinks (80 ml) twice a day - after lunch and dinner for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Probiotics |
| Placebo | Placebo comparator | Subjects in placebo group will receive milk drink without LcS (80 ml). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From week 0 to week 16
Secondary outcomes (5)
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
Measured: From week 0 to week 16
Changes in waist circumference (cm) over 16 weeks
The parameter will be measured using measuring tape.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: From week 0 to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start11 Sep 2020
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AflatoxicosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized , double-blind, placebo-controlled, parallel trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assoc. Prof. Dr. Rosita Jamaluddin, Universiti Putra Malaysia
- Investigators
- Assoc Prof Dr Rosita Jamaluddin, Principal investigator, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882294
- Sponsor's protocol ID
- PRO001
- Status last verified
- Jun 2022
- First submitted
- 14 Mar 2019
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40250564
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics and Its Associated Factors on Aflatoxin Biomarkers Among Healthy Subjects in Serdang and Kajang, Selangor: A Twelve-week Intervention
- ClinicalTrials.gov ID
- NCT03882294
- Acronym / sponsor ID
- PRO001
- Conditions
- Aflatoxicosis
- Keywords
- probiotics, aflatoxin biomarkers, healthy subjects, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized , double-blind, placebo-controlled, parallel trial
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Other: ProbioticsSubjects in probiotic group will receive fermented milk containing live cultures Lactobacillus casei Shirota (LcS), 3 x 10^10 CFU/bottle (80 ml) |
| Placebo | Placebo comparator | Other: PlaceboSubjects in placebo group will receive milk drink without LcS (80 ml). |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticsParticipants will be requested to consume the drinks (80 ml) twice a day - after lunch and dinner for 12 weeks. | Other | Probiotics |
| PlaceboParticipants will be requested to consume the drinks (80 ml) twice a day - after lunch and dinner for 12 weeks. | Other | Placebo |
Primary outcome
Changes in serum AFB1-lysine adducts (pg/mg albumin) over 16 weeks
Time frame: From week 0 to week 16
Analysis of serum AFB1-lysine adducts will be done using elisa kit through HPLC.
Changes in urinary AFM1 (ng/ml) over 16 weeks
Time frame: From week 0 to week 16
Analysis of urinary AFM1 will be done using elisa kit.
5 secondary outcomes
Changes in body mass index (kg/m^2) over 16 weeks
Time frame: From week 0 to week 16
Changes in waist circumference (cm) over 16 weeks
Time frame: From week 0 to week 16
Changes in physical activity level (MET-min/week) over 16 weeks
Time frame: From week 0 to week 16
Changes in dietary intake over 16 weeks
Time frame: From week 0 to week 16
Changes in knowledge, attitude and practice (KAP) on aflatoxin over 16 weeks
Time frame: From week 0 to week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Derived from this study: PubMed 40250564Chang 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assoc Prof Dr Rosita Jamaluddin principal investigator
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Aflatoxicosis, run by Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in serum AFB1-lysine adducts (pg/mg albumin) over 16 weeks (time frame: From week 0 to week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03882294, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.