Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04922476
Status:
COMPLETED
Last Update Posted:
2023-09-08
First Post:
2021-06-04
Brief Title:
Effect of 35624 Alflorex in Functional Gastrointestinal Disorders FGIDs in Children
Sponsor:
PrecisionBiotics Group Ltd
Organization:
PrecisionBiotics Group Ltd
Study Overview
Official Title:
Open Label Clinical Trial on the Efficacy of a Probiotic Strain of Bifidobacterium Longum 35624 Alflorex in Functional Gastrointestinal Disorders GFRS in Children 8 to 18 Years of Age
Status:
COMPLETED
Status Verified Date:
2023-09
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:
The aim of this study is to evaluate the effect of supplementation with Bifidobacterium longum 35624 Alflorex on frequency and severity of symptoms of abdominal pain using an adapted Irritable Bowel Symptom Severity Scoring System IBS-SSS to accurately reflect the pediatric population using the aid of the validated Numeric Pain Rating Scale NRS-II in children with Functional Gastrointestinal Disorders FGIDs
Detailed Description:
This is an open label study to assess the safety and effectiveness of Bifidobacterium longum 35624 Alflorex when consumed once daily by children with Functional Gastrointestinal Disorders FGIDs The 12-week intervention study will be conducted in 63 non-coeliac children aged 8 to 18 years old with an FGID who experience at least two episodes of abdominal pain per week The study will consist of 5 visits over a 14 week period commencing with a screening visit The second visit will be the baseline start of intervention followed by third mid-intervention fourth end of treatment and fifth follow up visit Questionnaires will be administered from the second to the fifth visit A blood sample will be taken before treatment to rule out coeliac disease
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?:
None