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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
1 dose of the probiotic every 24 hours, for 6-months.
1 dose of the placebo every 24 hours, for 6-months.
Hospital Universitario Infantil Niño Jesús
Madrid, Spain
RECRUITINGNumber of children with intestinal dysbiosis after 6 months of treatment.
Time frame: After 6 months of intervention.
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