Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-25 @ 5:02 PM
Study NCT ID:
NCT06352203
Status:
RECRUITING
Last Update Posted:
2025-06-03
First Post:
2024-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients
Sponsor:
ProbiSearch SL
Organization:
Study Overview
Official Title:
Randomized, Double-blind, Placebo-controlled Study to Evaluate the Modulating Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients With Neurodevelopmental Disorders.
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: