Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients
NCT ID: NCT06352203
Last Updated: 2025-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2024-04-12
2025-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Action of Probiotics on the Microbiota and Intestinal Permeability in Children With Neurodevelopmental Disorders and Their Influence on the Improvement of Language and Learning
NCT06200935
Efficacy of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders
NCT02722993
A Study of the Effects of Probiotics in Children Grades 1-3
NCT00635388
Tolerability and Functional Assessment of a Novel Children's Synbiotic
NCT04534036
Probiotic Mixture (L. Rhamnosus GG and L. Plantarum 299V) In Pediatric Irritable Bowel Syndrome
NCT07125625
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Probiotic
Probiotic
1 dose of the probiotic every 24 hours, for 6-months.
Placebo
Placebo
1 dose of the placebo every 24 hours, for 6-months.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Probiotic
1 dose of the probiotic every 24 hours, for 6-months.
Placebo
1 dose of the placebo every 24 hours, for 6-months.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
3 Years
7 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ProbiSearch SL
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Universitario Infantil Niño Jesús
Madrid, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AUT/23.02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.