Probiotic Treatment for Prader-Willi Syndrome

Fundació Sant Joan de Déu

Status: Completed

Conditions: Prader-Willi Syndrome

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Follow-up probiotic; Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT04685057

PIC-194-20

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 6 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with Prader-Willi Syndrome with genetic confirmation
• On a stable diet and medication regimen for at least the last two months before enrollment

Exclusion criteria

• Current enrollment in or discontinuation within the last 30 days from a clinical trial
• Patients with bariatric surgery in the last two years
• Patients with Type 2 Diabetes on insulin therapy
• Presence of other medical problems that would preclude study participation
• Unsuitable for inclusion in the study in the opinion of the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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41 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

This arm will receive placebo for 6 months then probiotic for 6 more months.

Treatment:

Dietary Supplement: Follow-up probiotic

Dietary Supplement: Placebo

Probiotic

Experimental group

Description:

This arm will receive probiotic for 6 months then will keep receiving probiotic for 6 more months.

Treatment:

Dietary Supplement: Follow-up probiotic

Dietary Supplement: Probiotic