NCT04685057

Probiotic Treatment for Prader-Willi Syndrome

Probiotics as a Long-term Treatment Strategy for Prader-Willi Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Fundació Sant Joan de Déu · Academic / Other
• Sex: All
• Age: 6 Years – 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prader-Willi Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	Intervention with a daily dose of placebo for 6 months
DIETARY_SUPPLEMENT	Probiotic	Intervention with a daily dose of probiotic for 6 months
DIETARY_SUPPLEMENT	Follow-up probiotic	Intervention with a daily dose of probiotic for 6 months

Timeline

• Start date: 2021-01-11
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2020-12-28
• Last updated: 2022-08-25

Locations

1 site across 1 country: Spain