Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients

Not Applicable

Recruiting

• Conditions: Neurodevelopmental Disorders
• Interventions: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

• Registration Number: NCT06352203
• Lead Sponsor: ProbiSearch SL

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-01
• Study First Posted: 2024-04-08
• Study Start: 2024-04-12
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2025-09
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of children with intestinal dysbiosis after 6 months of treatment.	After 6 months of intervention.

Trial Locations

Locations (1)

Hospital Universitario Infantil Niño Jesús; 🇪🇸 Madrid, Spain