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Alanyl-glutamine for CDI

Aðeins skráðir notendur geta þýtt greinar
Skráðu þig / skráðu þig
Krækjan er vistuð á klemmuspjaldið
StaðaEkki enn að ráða
Styrktaraðilar
University of Virginia
Samstarfsmenn
Imperial College London

Lykilorð

Útdráttur

This is a randomized, double-blind, placebo-controlled trial to determine the optimal dose and safety of oral alanyl-glutamine between 4, 24, and 44 g doses administered for 10 days with standard therapy among first time incident cases of uncomplicated C. difficile infection (CDI) in hospitalized persons aged 65 or older. Our hypothesis is that alanyl-glutamine supplementation will decrease recurrence and mortality from CDI and these outcomes will be associated with improvement of inflammatory markers and restoration of intestinal microbiota function.

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

Clostridioides Difficile Infection
Clostridium Difficile Infection
Clostridium Difficile Diarrhea
Clostridia Difficile Colitis

Íhlutun / meðferð

Drug: Alanyl-glutamine

Stig

Stig 2

Armhópar

ArmurÍhlutun / 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 námsAll
Tekur við heilbrigðum sjálfboðaliðum
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]

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