Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients
ConditionNeurodevelopmental Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-7
SponsorProbiSearch SL
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)).
Trial design
Design model
Parallel
Treatments tested in this trial
Probiotic
Dietary supplement1 dose of the probiotic every 24 hours, for 6-months.
Placebo
Dietary supplement1 dose of the placebo every 24 hours, for 6-months.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ProbioticActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of children with intestinal dysbiosis after 6 months of treatment.
Time frame
After 6 months of intervention.Sponsors and contacts
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Source ClinicalTrials.gov