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

NCT06200935 | Completed

• 1 other identifier: MICROBIOTA
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodevelopmental Disorders

Keywords

Neurodevelopment; Probiotics; Microbiota; Learning; Children

Outcome Measures

Primary Outcomes (2)

• Microbiota

  Examination of fecal samples

  Through study completion, an average of 6 months

• Intestinal permeability

  Examination of fecal samples and a complete medical history and a survey aimed mainly at ruling out digestive symptoms

  Through study completion, an average of 6 months

Secondary Outcomes (3)

• Analyze improvement in language, behavior and learning

  Through study completion, an average of 6 months

• Analyze the outcome in pre-existing digestive disorders

  Through study completion, an average of 6 months

• Analyze the composition of the microbiota and its improvement

  Through study completion, an average of 6 months

Study Arms (1)

Children with neurodevelopmental disorders

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

Dietary Supplement: Probiotic blend

Interventions

Probiotic blend DIETARY_SUPPLEMENT

Administration of one stick of combined probiotics per day for 5 months

Children with neurodevelopmental disorders

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Boys and girls with neurodevelopmental disorders between 3 and 16 years of age, belonging to two educational centers in Madrid, which are 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto de Genética Médica y Molecular: lead
• Industrial Farmacéutica Cantabria, S.A.: collaborator

Study Sites (1)

Mencía Hermosa Vicente

Madrid, 28043, Spain

Location

Related Publications (10)

• Navarro F, Liu Y, Rhoads JM. Can probiotics benefit children with autism spectrum disorders? World J Gastroenterol. 2016 Dec 14;22(46):10093-10102. doi: 10.3748/wjg.v22.i46.10093.

  PMID: 28028357 RESULT

• Srikantha P, Mohajeri MH. The Possible Role of the Microbiota-Gut-Brain-Axis in Autism Spectrum Disorder. Int J Mol Sci. 2019 Apr 29;20(9):2115. doi: 10.3390/ijms20092115.

  PMID: 31035684 RESULT

• McElhanon BO, McCracken C, Karpen S, Sharp WG. Gastrointestinal symptoms in autism spectrum disorder: a meta-analysis. Pediatrics. 2014 May;133(5):872-83. doi: 10.1542/peds.2013-3995.

  PMID: 24777214 RESULT

• Johnson D, Letchumanan V, Thurairajasingam S, Lee LH. A Revolutionizing Approach to Autism Spectrum Disorder Using the Microbiome. Nutrients. 2020 Jul 3;12(7):1983. doi: 10.3390/nu12071983.

  PMID: 32635373 RESULT

• Strati F, Cavalieri D, Albanese D, De Felice C, Donati C, Hayek J, Jousson O, Leoncini S, Renzi D, Calabro A, De Filippo C. New evidences on the altered gut microbiota in autism spectrum disorders. Microbiome. 2017 Feb 22;5(1):24. doi: 10.1186/s40168-017-0242-1.

  PMID: 28222761 RESULT

• Bezawada N, Phang TH, Hold GL, Hansen R. Autism Spectrum Disorder and the Gut Microbiota in Children: A Systematic Review. Ann Nutr Metab. 2020;76(1):16-29. doi: 10.1159/000505363. Epub 2020 Jan 24.

  PMID: 31982866 RESULT

• Liu X, Cao S, Zhang X. Modulation of Gut Microbiota-Brain Axis by Probiotics, Prebiotics, and Diet. J Agric Food Chem. 2015 Sep 16;63(36):7885-95. doi: 10.1021/acs.jafc.5b02404. Epub 2015 Sep 1.

  PMID: 26306709 RESULT

• Martin R, Laval L, Chain F, Miquel S, Natividad J, Cherbuy C, Sokol H, Verdu EF, van Hylckama Vlieg J, Bermudez-Humaran LG, Smokvina T, Langella P. Bifidobacterium animalis ssp. lactis CNCM-I2494 Restores Gut Barrier Permeability in Chronically Low-Grade Inflamed Mice. Front Microbiol. 2016 May 6;7:608. doi: 10.3389/fmicb.2016.00608. eCollection 2016.

  PMID: 27199937 RESULT

• Hughes KR, Harnisch LC, Alcon-Giner C, Mitra S, Wright CJ, Ketskemety J, van Sinderen D, Watson AJ, Hall LJ. Bifidobacterium breve reduces apoptotic epithelial cell shedding in an exopolysaccharide and MyD88-dependent manner. Open Biol. 2017 Jan;7(1):160155. doi: 10.1098/rsob.160155.

  PMID: 28123052 RESULT

• Fornai M, Pellegrini C, Benvenuti L, Tirotta E, Gentile D, Natale G, Ryskalin L, Colucci R, Piccoli E, Ghelardi E, Blandizzi C, Antonioli L. Protective effects of the combination Bifidobacterium longum plus lactoferrin against NSAID-induced enteropathy. Nutrition. 2020 Feb;70:110583. doi: 10.1016/j.nut.2019.110583. Epub 2019 Sep 12.

  PMID: 31739175 RESULT

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Pablo Lapunzina

  Instituto de Genética Médica y Molecular (INGEMM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: January 11, 2024
• Study Start: October 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: October 1, 2022
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

ES (1)