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RECRUITING
NCT06352203
NA

Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients

Sponsor: ProbiSearch SL

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Hospital Universitario Infantil Niño Jesús

Madrid, Spain