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RecruitingNot ApplicableNCT05794815

Modulation of Gut Microbiota by Probiotic in Children With Respiratory Symptoms

Sponsor

Min-Tze LIONG

Enrollment

120 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

Respiratory Infection (for Example, Pneumonia, Bronchitis)

Summary

This project aims to study the benefits of probiotics namely Bifidobacterium infantis YLGB-1496 in modulating gut microbiota of children with respiratory symptoms, among pre-school children in Malaysia aged \>12 months old, \<7 years old.

Eligibility

Min Age: 12 MonthsMax Age: 7 Years

Inclusion Criteria5

  • Preschool children (>12 months old, <7 years old).
  • Having respiratory symptoms (having at least two of the following signs and symptoms: fever (even if only reported not measured), nasal obstruction, chills, sore throat, headache, cough, runny nose, olfactory disturbances, or taste disturbances; Pucarelli-Lebreiro et al., 2022).
  • Healthy with current weight of P20-P80 percentile chart of children
  • Infant formula powder does not contain probiotics; prebiotics FOS is not allowed, GOS <2g/ 100g is allowed
  • Willing to commit throughout the experiment

Exclusion Criteria10

  • Long term medication >6 months for any diseases
  • Deformity
  • Mothers with metabolic and/or chronic diseases
  • Current or previous diseases, conditions or interventions that may interfere with the study (such as tolerance and/or growth and development), such as gastrointestinal malformations, chronic diarrhea, malabsorption syndromes, malnutrition, congenital immunodeficiency or surgery
  • Oral antibiotics within 2 weeks before the intervention
  • Nutritional supplements containing probiotics and prebiotics (except infant formula) within 2 weeks before the intervention
  • Foods for special medical purposes or non-standard formula powders for lactose intolerance and galactosemia
  • Probiotic allergies or possible food allergies (milk, etc.)
  • Participated in other clinical studies 4 weeks before the intervention
  • Unwilling to participate for any particular reason

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Interventions

DIETARY_SUPPLEMENTProbiotic

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

DIETARY_SUPPLEMENTPlacebo

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

Locations(1)

UKM Medical Centre

Cheras, Kuala Lumpur, Malaysia

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NCT05794815