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NCT04685057
Probiotic Treatment for Prader-Willi Syndrome
NA trial testing Placebo in Prader-Willi Syndrome in 41 participants. Completed in 30 June 2022.
30 June 2022
Quick facts
| Lead sponsor | Fundació Sant Joan de Déu |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 41 |
| Start date | 11 January 2021 |
| Primary completion | 30 June 2022 |
| Estimated completion | 30 June 2022 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Placebo
- Probiotic
- Follow-up probiotic
Conditions studied
- Prader-Willi Syndrome — all drugs for Prader-Willi Syndrome →
Sponsor
Fundació Sant Joan de Déu — full company profile →
Who can join
Adults 6 to 30, any sex, with Prader-Willi Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04685057
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Prader-Willi Syndrome
Currently open trials in the same condition.
- NCT06877715 — Autistic Symptomatology and Sensory Profile in Children With Prader-Willi Syndrome · recruiting
- NCT06772597 — A Study of Setmelanotide in Patients With Prader-Willi Syndrome · Phase 2 · active not recruiting
- NCT06573723 — Institutional Registry of Rare Diseases · recruiting
- NCT06239116 — A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment · Phase 1, PHASE2 · recruiting
- NCT06144645 — A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS · Phase 3 · active not recruiting
Other Fundació Sant Joan de Déu trials
Trials by the same sponsor.
- NCT07508917 — Effects of 5-Methyltetrahydrofolic Acid Supplementation on Maternal Health and One-Carbon Metabolism During Lactation · Phase 1, PHASE2 · not yet recruiting
- NCT06556251 — Effectiveness of a Digital Platform in Engagement and Prognosis of Patients in an Early Intervention Pychosis Programme · NA · recruiting
- NCT06309121 — Effects of the Postbiotic Blend ABB C3 on Adiposity and Glucose Metabolism in Children and Adolescents · NA · active not recruiting
- NCT07091344 — Cognitive and Metacognitive Evaluation in VR-Based Avatar Therapy for Psychosis · NA · recruiting
- NCT06340555 — Intervention to Prevent Mental Health Disorders of Women and Their Partners Who Experienced Pregnancy Loss · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04685057 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundació Sant Joan de Déu
- Last refreshed: 25 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04685057.
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