Probiotic Treatment for Prader-Willi Syndrome

Plain-language summary

This study evaluates a probiotic supplement compared with placebo in people with genetically confirmed Prader-Willi syndrome. It enrolled patients on a stable diet and medication regimen for at least two months whose diagnosis was genetically confirmed. It was conducted as a study without a phase designation and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

Fundació Sant Joan de Déu

Intervention

Placebo, Probiotic, Follow-up probiotic

Start date

1/11/2021

Estimated completion

6/30/2022

Countries

Spain

Related genes

Locations

• Barcelona, Spain

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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