Targeting the Gut Microbiome for Prader-Willi Syndrome Treatment
Nøgleord
Abstrakt
Datoer
Sidst bekræftet: | 02/29/2020 |
Først indsendt: | 05/01/2018 |
Anslået tilmelding indsendt: | 06/05/2018 |
Først indsendt: | 06/06/2018 |
Sidste opdatering indsendt: | 03/03/2020 |
Sidste opdatering indsendt: | 03/04/2020 |
Faktisk startdato for undersøgelsen: | 12/31/2017 |
Anslået primær afslutningsdato: | 01/30/2019 |
Anslået afslutningsdato for undersøgelsen: | 01/30/2019 |
Tilstand eller sygdom
Intervention / behandling
Dietary Supplement: Placebo
Dietary Supplement: Probiotic
Fase
Armgrupper
Arm | Intervention / behandling |
---|---|
Placebo Comparator: Placebo | Dietary Supplement: Placebo Intervention with a daily dose of placebo |
Experimental: Probiotic | Dietary Supplement: Probiotic Intervention with a daily dose of probiotic |
Kriterier for støtteberettigelse
Alder berettiget til undersøgelse | 2 Years Til 2 Years |
Køn, der er berettiget til undersøgelse | All |
Accepterer sunde frivillige | Ja |
Kriterier | 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 - Presence of other medical problems that would preclude study participation - Patients with a history of bariatric surgery - Unsuitable for inclusion in the study in the opinion of the investigator |
Resultat
Primære resultatforanstaltninger
1. Change in percent body fat [3 months]
Sekundære resultatforanstaltninger
1. Change in lipid profile (triglyceride, cholesterol) [3 months]
2. Change in glucose metabolic parameters (glucose, insulin, HbA1c) [3 months]
3. Change in circulating cytokine levels [3 months]
4. Change in hyperphagia [3 months]
5. Change in thermoregulation [3 months]
Andre resultater
1. Change in plasma metabolome [3 months]
2. Change in urine metabolome [3 months]
3. Change in intestinal microbiome [3 months]