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

Neurodevelopmental Disorders Clinical Trial

Official title:

Results of the Action of a Combination of Probiotics on the Microbiota and Intestinal Permeability in Children With Neurodevelopmental Disorders and Their Influence on the Improvement of Language, Behavioral Evolution and Learning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06200935
• Other study ID #: MICROBIOTA
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: January 2024
• Source: Instituto de Genética Médica y Molecular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurodevelopmental Disorders

Intervention

Dietary Supplement:
• Probiotic blend
Administration of one stick of combined probiotics per day for 5 months

Locations

Country	Name	City	State
Spain	Mencía Hermosa Vicente	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Genética Médica y Molecular	Industrial Farmacéutica Cantabria, S.A.

Country where clinical trial is conducted

Spain, 

References & Publications (10)

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. — View Citation

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. N — View Citation

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):1601 — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiota	Examination of fecal samples	Through study completion, an average of 6 months
Primary	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	Analyze improvement in language, behavior and learning	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	Through study completion, an average of 6 months
Secondary	Analyze the outcome in pre-existing digestive disorders	A complete medical history and a survey	Through study completion, an average of 6 months
Secondary	Analyze the composition of the microbiota and its improvement	By collecting fecal samples	Through study completion, an average of 6 months