NCT06352203

Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients

Randomized, Double-blind, Placebo-controlled Study to Evaluate the Modulating Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients With Neurodevelopmental Disorders.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: ProbiSearch SL · Industry
• Sex: All
• Age: 3 Years – 7 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neurodevelopmental Disorders

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	1 dose of the probiotic every 24 hours, for 6-months.
DIETARY_SUPPLEMENT	Placebo	1 dose of the placebo every 24 hours, for 6-months.

Timeline

• Start date: 2024-04-12
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2024-04-08
• Last updated: 2026-02-25

Locations

1 site across 1 country: Spain