Using probiotics to improve gut health in young children
Modulation of Gut Microbiota by Probiotic in Children
This study is testing if a specific probiotic can help improve gut health and reduce the risk of diarrhea in healthy preschool children under 7 years old in Malaysia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 1 Month to 7 Years |
| Sex | All |
| Sponsor | Universiti Sains Malaysia Academic / other |
| Locations | 1 site (Cheras, Kuala Lumpur) |
| Trial ID | NCT06474234 on ClinicalTrials.gov |
What this trial studies
This project investigates the effects of the probiotic Bifidobacterium infantis YLGB-1496 on the gut microbiota of generally healthy preschool children under 7 years old in Malaysia. The study aims to determine how these probiotics can enhance intestinal microbial balance and potentially improve immune responses, thereby reducing the risk of gastrointestinal disorders such as diarrhea. Participants will receive either the probiotic or a placebo to assess the efficacy of the intervention. The research is motivated by the high incidence of diarrhea-related illnesses in young children, which remains a significant global health issue.
Who should consider this trial
Good fit: Ideal candidates for this study are generally healthy preschool children under 7 years old who were born full-term.
Not a fit: Patients with serious acute or chronic diseases or those who have recently taken probiotics or antibiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved gut health and reduced incidence of gastrointestinal disorders in young children.
How similar studies have performed: Previous studies have shown that probiotics can effectively reduce gastrointestinal symptoms in children, indicating a promising approach for this intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Preschool children (\<7 years old) * Born full-term (≥37 weeks delivered) * In generally good health as determined by the investigator Exclusion criteria * 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.) * Using other drugs that may interfere with the experimental results * Participated in other experimental trials less than 8-weeks prior to this study
Where this trial is running
Cheras, Kuala Lumpur
- UKM Medical Centre — Cheras, Kuala Lumpur, Malaysia (Recruiting)
Study contacts
- Study coordinator: Adli Ali, MD
- Email: adli.ali@ppukm.ukm.edu.my
- Phone: 603 8921 5555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.