Probiotics for gut health in children with neurodevelopmental disorders
Randomized, Double-blind, Placebo-controlled Study to Evaluate the Modulating Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients With Neurodevelopmental Disorders.
This study is testing if a probiotic supplement can improve gut health and symptoms in young children with autism spectrum disorder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 3 Years to 7 Years |
| Sex | All |
| Sponsor | ProbiSearch SL Industry-sponsored |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06352203 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the impact of a probiotic supplement on the gut microbiota of children aged 3 to 7 years who have been diagnosed with neurodevelopmental disorders, specifically autism spectrum disorder. The study will be randomized, double-blind, and placebo-controlled, with participants assigned to either a probiotic group or a control group receiving a placebo. Over a period of approximately six months, the effects of the probiotic on gastrointestinal symptoms and microbiota composition will be assessed. The study seeks to understand the relationship between gut health and neurodevelopmental symptoms in pediatric patients.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 7 years with autism spectrum disorder and gastrointestinal symptoms.
Not a fit: Patients who have recently taken antibiotics or probiotics, or have certain gastrointestinal or endocrinological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve gastrointestinal symptoms and overall health in children with neurodevelopmental disorders.
How similar studies have performed: Other studies have indicated potential benefits of probiotics in managing gastrointestinal symptoms in similar populations, suggesting a promising avenue for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children aged 3 to 7 years old. * Diagnosed with autism spectrum disorder, according to the clinical criteria of the "Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)" and who meet criteria for ASD according to the ADOS-2 classification. * Presenting one or more gastrointestinal symptoms (constipation, diarrhoea, abnormal stools, painful defecation, abdominal pain, reflux, bloating, flatulence). * Written informed consent signed by the parent or legal guardian with express or tacit consent of the other parent. Exclusion Criteria: * With intake of antibiotics in the last month. * With intake of probiotics in the last two weeks. * Diagnosed with short bowel syndrome or has undergone relevant surgery on the gastrointestinal tract. * Exhibiting a defect in the intestinal epithelial barrier (e.g. inflammatory bowel disease (IBD)). * Diagnosed with endocrinological diseases such as diabetes mellitus, hypo- and hyperthyroidism, Cushing's disease, Addison's disease, etc. * Having heart failure and a cardiac medical history (e.g. artificial heart valve, medical history of infective endocarditis, rheumatic fever, or cardiac malformation). * Congenital or acquired immunodeficiency. * Immunocompromised (e.g., cancer and/or transplant patients taking certain immunosuppressive drugs, patients with inherited diseases that affect or may affect the immune system). * Uncertainty on the part of the investigator about the willingness or ability of the minor's parents or legal guardian to comply with the requirements of the protocol. * With oral hyper sensitivity impairments that prevent the uptake of the study product.
Where this trial is running
Madrid
- Hospital Universitario Infantil Niño Jesús — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Susana Manzano Jiménez, PhD
- Email: susana.manzano@probisearch.com
- Phone: +34 918035179
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.