Health TrialsbyHealthPanel

Modulation of Gut Microbiota by Probiotic in Children

ConditionGenerally Healthy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-7
SponsorMin-Tze LIONG

About this trial

This project aims to study the benefits of probiotics namely Bifidobacterium infantis YLGB-1496 in modulating gut microbiota of healthy children, among pre-school children in Malaysia \<7 years old.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Preschool children (<7 years old)

Born full-term (≥37 weeks delivered)

In generally good health as determined by the investigator

Disqualifiers

Had taken probiotics or prebiotics within past 4-weeks

Had taken milk powder or supplements containing probiotics within past 4-weeks

History of using antibiotic within past 4-weeks

Suffering from serious acute or chronic diseases (cardiovascular disease, gastrointestinal disease, endocrine disease, immune system disease, metabolic disease, etc.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Probiotic

    Dietary supplement

    Bifidobacterium infantis YLGB-1496 at 1x10 log CFU/day for 12 weeks

  • Placebo

    Dietary supplement

    Intervention consists of daily administration of 2g of maltodextrin, administered daily for 12-weeks)

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: ProbioticExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Microbiota profiles of fecal samples in generally healthy children upon administration of probiotic as assessed via pyrosequencing

Differences in microbiota abundance in fecal sample of generally healthy children upon administration o probiotic compared to placebo

Time frame
12-weeks

Secondary outcomes

1

Clinical respiratory symptoms duration and frequency in generally healthy children upon administration of probiotic as assessed using the Monthly Health Questionnaire (as used in ClinicalTrials.gov (identifier number NCT02434042)

Changes in duration and frequency of respiratory illnesses symptoms from generally healthy children on probiotic or placebo after 12-weeks, via the use of questionnaire.

Time frame
12-weeks
2

Clinical gastrointestinal symptoms in generally healthy children upon administration of probiotic as assessed using the Monthly Gastrointestinal Questionnaire as used in ClinicalTrials.gov (identifier number NCT02434042)

Differences in duration and frequency of gastrointestinal symptoms upon administration of probiotic compared to placebo

Time frame
12-weeks
3

Immunity profiles in generally healthy children upon administration of probiotic via the use of oral swabs

Differences in concentrations of proteins such as interleukins (IL-10, IL-4, IL-6, Tumour Necrosis Factor-alpha, Interferon gamma) in swab samples (ug/mL) upon administration of probiotic compared to placebo

Time frame
12-weeks

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

UKM Medical CentreRecruiting56000, Cheras, Kuala LumpurMalaysiaMalaysia

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Min-Tze LIONG

Lead sponsor

Universiti Sains Malaysia

Sponsor institution

National University of Malaysia

Collaborator

Source ClinicalTrials.gov
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