Alanyl-glutamine for CDI
Lykilorð
Útdráttur
Dagsetningar
Síðast staðfest: | 02/29/2020 |
Fyrst lagt fram: | 03/08/2020 |
Áætluð skráning lögð fram: | 03/08/2020 |
Fyrst sent: | 03/11/2020 |
Síðasta uppfærsla lögð fram: | 03/08/2020 |
Síðasta uppfærsla sett upp: | 03/11/2020 |
Raunverulegur upphafsdagur náms: | 07/31/2020 |
Áætlaður aðallokunardagur: | 07/31/2024 |
Áætlaður dagsetningu rannsóknar: | 10/31/2024 |
Ástand eða sjúkdómur
Íhlutun / meðferð
Drug: Alanyl-glutamine
Stig
Armhópar
Armur | Íhlutun / meðferð |
---|---|
Placebo Comparator: Alanyl-glutamine 0g | |
Experimental: Alanyl-glutamine 4g | |
Experimental: Alanyl-glutamine 24g | |
Experimental: Alanyl-glutamine 44g |
Hæfniskröfur
Aldur hæfur til náms | 65 Years Til 65 Years |
Kyn sem eru hæf til náms | All |
Tekur við heilbrigðum sjálfboðaliðum | Já |
Viðmið | Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged > 65 years 4. Admitted in the hospital 5. Presence of diarrhea* 6. Stool positive for C. difficile tcdB and TcdB 7. 1st episode of C. difficile infection, non-severe or severe uncomplicated 8. Within 48 hours of receiving standard therapy (oral vancomycin at UVA) Exclusion Criteria: 1. At enrollment, presence of any of the following: - Hypotension or shock - Megacolon or moderate to severe ileus - Acute abdomen - Admission to intensive care unit 2. Inability to tolerate oral or enteral medication 3. Presence of other known infectious etiology of diarrhea 4. Inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis) or other etiology of non-infectious diarrhea 5. Enrollment in another investigational drug trial 6. Current use of alternative treatment for CDI (e.g. antibiotics other than vancomycin or fidaxomicin; IVIg; fecal transplant). 7. On probiotics and not willing to discontinue. 8. Cirrhosis or in participants with ALT > 3X normal 9. End stage renal disease, on dialysis, or creatinine clearance or estimated GFR of <30mL/min even after adequate hydration 10. Life expectancy of < 6 months. |
Útkoma
Aðal niðurstöður ráðstafanir
1. Recurrent C. difficile infection [Within 60 days post-treatment]
Aðgerðir vegna aukaatriða
1. Mortality [Within 60 days post-treatment]