Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04685057
Status:
COMPLETED
Last Update Posted:
2022-08-25
First Post:
2020-12-02
Brief Title:
Probiotic Treatment for Prader-Willi Syndrome
Sponsor:
Fundació Sant Joan de Déu
Organization:
Fundació Sant Joan de Déu
Study Overview
Official Title:
Probiotics as a Long-term Treatment Strategy for Prader-Willi Syndrome
Status:
COMPLETED
Status Verified Date:
2022-01
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:
A whole new research area studying the function of intestinal microorganisms also known as gut microbiota has emerged during the last decade As a result dietary supplementation with specific bacteria or probiotics holds great promise as a therapeutic strategy for a wide range of diseases from obesity to anxiety and depression all of which are major characteristics of Prader-Willi syndrome PWS
The main objective of the current proposal is to determine the effects of Bifidobacterium animalis subsp lactis strain BPL1 supplementation in children and young adults with PWS Specifically participants will receive placebo or BPL1 for 6 months and then this phase will be followed by a 6-month extension period in which all participants will receive BPL1 This study will allow us to 1 determine the effects on fat mass and glucose metabolism and 2 explore the effects on mental health symptoms by studying potential structural changes in the brain by magnetic resonance imaging MRI as well as using a number of psychiatric questionnaires
The main objective of the current proposal is to determine the effects of Bifidobacterium animalis subsp lactis strain BPL1 supplementation in children and young adults with PWS Specifically participants will receive placebo or BPL1 for 6 months and then this phase will be followed by a 6-month extension period in which all participants will receive BPL1 This study will allow us to 1 determine the effects on fat mass and glucose metabolism and 2 explore the effects on mental health symptoms by studying potential structural changes in the brain by magnetic resonance imaging MRI as well as using a number of psychiatric questionnaires
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?:
None