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Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients
Sponsor: ProbiSearch SL
Summary
Numerous studies have described an altered gut microbiota composition (dysbiosis) in patients with neurodevelopmental disorders that can be correlated with their symptoms, especially gastrointestinal symptoms. An interventional, randomised, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic supplement on the microbiota composition of children aged 3-7 years with neurodevelopmental issues. The duration of the study will be of 6 months approximately, including 6 months of product intake. Participants will be randomly assigned to one of the two study groups: control group with placebo administration or probiotic administration group.
Official title: Randomized, Double-blind, Placebo-controlled Study to Evaluate the Modulating Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients With Neurodevelopmental Disorders.
Key Details
Gender
All
Age Range
3 Years - 7 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-04-12
Completion Date
2026-12
Last Updated
2026-02-25
Healthy Volunteers
No
Conditions
Interventions
Probiotic
1 dose of the probiotic every 24 hours, for 6-months.
Placebo
1 dose of the placebo every 24 hours, for 6-months.
Locations (1)
Hospital Universitario Infantil Niño Jesús
Madrid, Spain