Actively Recruiting
Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients
Led by ProbiSearch SL · Updated on 2026-02-25
60
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Numerous studies have described an altered gut microbiota composition (dysbiosis) in patients with neurodevelopmental disorders that can be correlated with their symptoms, especially gastrointestinal symptoms. An interventional, randomised, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic supplement on the microbiota composition of children aged 3-7 years with neurodevelopmental issues. The duration of the study will be of 6 months approximately, including 6 months of product intake. Participants will be randomly assigned to one of the two study groups: control group with placebo administration or probiotic administration group.
CONDITIONS
Official Title
Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 3 to 7 years old
- Diagnosed with autism spectrum disorder according to DSM-5 and ADOS-2 criteria
- Having one or more gastrointestinal symptoms such as constipation, diarrhoea, abnormal stools, painful defecation, abdominal pain, reflux, bloating, or flatulence
- Written informed consent signed by parent or legal guardian with consent from the other parent
You will not qualify if you...
- Use of antibiotics in the last month
- Use of probiotics in the last two weeks
- Diagnosed with short bowel syndrome or history of significant gastrointestinal surgery
- Presence of intestinal epithelial barrier defects, including inflammatory bowel disease
- Diagnosed with endocrinological diseases like diabetes mellitus, thyroid disorders, Cushing's disease, or Addison's disease
- History of heart failure or cardiac conditions such as artificial heart valve, infective endocarditis, rheumatic fever, or cardiac malformation
- Having congenital or acquired immunodeficiency
- Being immunocompromised due to cancer, transplant, immunosuppressive drugs, or inherited immune diseases
- Investigator uncertainty about parents' or guardians' ability or willingness to follow the protocol
- Oral hypersensitivity impairing intake of the study product
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Universitario Infantil Niño Jesús
Madrid, Spain
Actively Recruiting
Research Team
S
Susana Manzano Jiménez, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here