Action of Probiotics on the Microbiota and Intestinal Permeability in Children With Neurodevelopmental Disorders and Their Influence on the Improvement of Language and Learning

Completed

• Conditions: Neurodevelopmental Disorders
• Interventions: Dietary Supplement: Probiotic blend

• Registration Number: NCT06200935
• Lead Sponsor: Instituto de Genética Médica y Molecular

Brief Summary

The study included boys and girls with neurodevelopmental disorders between the ages of 3 and 16 years, belonging to two educational centers in Madrid, attended by children with this type of disorder. Both centers have similar characteristics in terms of the type of feeding and management of the children attending them. The study will be randomized, so that probiotics will be administered to some children and placebos to others; and blinded, so that neither the patient nor his family will know whether probiotic or placebo is administered.

The aim of this project is to study the results obtained on microbiota, intestinal permeability, language, behavior and learning of a probiotic combination that will be administered to children in several educational centers that care for children with neurodevelopmental disorders for 5 months.

Detailed Description

The trial was conducted in 4 stages:

* Probiotic development, which will be randomized, so that some children will receive the probiotic and others placebos, and blinded, so that neither the children nor their relatives will know whether they take placebo or probiotic.

* Initial survey to rule out digestive symptoms and resolve possible doubts. Data will be collected on type of housing, location, number of family members, and others. Collection of fecal samples prior to the administration of the probiotic, to carry out a microbiota and intestinal permeability study.

* Administration of the probiotic preparation or placebo to the subjects for 5 months. Monitoring will be done within each center and in the middle of the treatment the doctors will make a face-to-face visit to see the children.

* In the last phase a new online visit is made where a complete clinical history and a survey to rule out digestive symptomatology are evaluated. A neurocognitive evaluation is also done using the SENA behavioral test. New fecal samples are collected for a microbiota and intestinal permeability study following the same procedure as in the second stage.

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2022-08-01
• Study Completion: 2022-10-01
• Study First Submitted: 2023-12-05
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-09
• Last Update Submitted: 2024-01-09
• Study First Posted: 2024-01-11
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Children with neurodevelopmental disorders between 3 and 16 years old
• Similar characteristics in terms of type of food

Exclusion Criteria

• Digestive symptomatology: gastroesophageal reflux, abdominal pain, flatulence, dysphagia, abdominal distension or constipation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with neurodevelopmental disorders	Probiotic blend	Boys and girls with neurodevelopmental disorders between 3 and 16 years of age, belonging to two educational centers in Madrid, attended by children with this type of disorders. Both centers have similar characteristics in terms of the type of feeding and management of the children attending them

Primary Outcome Measures

Name	Time	Method
Microbiota	Through study completion, an average of 6 months	Examination of fecal samples
Intestinal permeability	Through study completion, an average of 6 months	Examination of fecal samples and a complete medical history and a survey aimed mainly at ruling out digestive symptoms

Secondary Outcome Measures

Name	Time	Method
Analyze improvement in language, behavior and learning	Through study completion, an average of 6 months	By monitoring at the school, asking family members and with a face-to-face visit by the doctor.; SENA behavioral test is performed at the end of the study
Analyze the outcome in pre-existing digestive disorders	Through study completion, an average of 6 months	A complete medical history and a survey
Analyze the composition of the microbiota and its improvement	Through study completion, an average of 6 months	By collecting fecal samples

Trial Locations

Locations (1)

Mencía Hermosa Vicente; 🇪🇸 Madrid, Spain