MedTrace Logo

Probiotic Treatment for Prader-Willi Syndrome

NCT04685057 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2022-08-25

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Fundació Sant Joan de Déu

    lead OTHER

Principal Investigators

  • Marta Ramon-Krauel · Hospital Sant Joan de Deu

  • Carles Lerin, PhD · Fundació Sant Joan de Déu

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-11
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04685057 on ClinicalTrials.gov