Autism Spectrum Disorder Clinical Trials

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The Effect of a Multispecies Probiotics on Autism Symptoms in Children

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

In this trial, the investigators aim to evaluate the impact of a multispecies probiotic consisting of Bacillus subtilis W201, Bifidobacterium infantis W17, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus rhamnosus W140, Lactococcus lactis W19, Propionibacterium freudenreichii W200, on the severity of autism symptoms, quality of life, gastrointestinal symptoms, sleep disturbances, parental stress levels and urinary p-cresol concentrations in children with Autism Spectrum Disorder aged 7 to 15 years.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 15
Healthy Volunteers: f
View:

• Diagnosis of ASD according to the Diagnostic and Statistical Manual of Mental Disorders, the fifth edition (DSM-5) or International Classification of Diseases, Tenth Revision (ICD-10).

• Children either not taking any medication or receiving the same medication for the last 2 months.

• Patients, or their parents/caregivers, are willing to provide written informed consent, proceed with nutritional supplements throughout the 3-month trial, refrain from starting any kind of special diet for the duration of the study, and complete the questionnaires at two time points during the study.

Locations
Other Locations
Poland
Department of Paediatrics, The Medical University of Warsaw
RECRUITING
Warsaw
Department of Paediatrics, The Medical University of Warsaw
RECRUITING
Warsaw
Department of Paediatrics, The Medical University of Warsaw
RECRUITING
Warsaw
Contact Information
Primary
Maja Kotowska, MD
kotowska.maja@gmail.com
+48223179536
Backup
Jan Łukasik, MD, PhD
jan.lukasik@wum.edu.pl
+48223179536
Time Frame
Start Date: 2024-08-07
Estimated Completion Date: 2026-07-30
Participants
Target number of participants: 110
Treatments
Experimental: Multispecies probiotics group
55 participants
Placebo_comparator: Control group
55 participants
Related Therapeutic Areas
Sponsors
Collaborators: Winclove Probiotics B.V.
Leads: Medical University of Warsaw

This content was sourced from clinicaltrials.gov

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