Modulation of Gut Microbiota by Probiotic in Children With Respiratory Symptoms (NCT05794815) | Clinical Trial Compass
UnknownNot Applicable
Modulation of Gut Microbiota by Probiotic in Children With Respiratory Symptoms
Malaysia120 participantsStarted 2023-05-01
Plain-language 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.
Who can participate
Age range12 Months – 7 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Microbiota profiles of fecal samples in children with respiratory tract infections upon administration of probiotic as assessed via pyrosequencing