RECRUITING

Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)

Conditions

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

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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, or outpatient, persons aged 18 or older. The investigators 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.

Official Title

Alanyl-glutamine Supplementation of Standard Treatment for C. Difficile Infection: a Randomized, Double-blind, Placebo-controlled Trial

Quick Facts

Study Start:2021-06-01

Study Completion:2027-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04305769

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 105 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 18 years and older. 4. Admitted to UVA hospital, or seen as an outpatient, or seen at Carilion hospital. 5. Presence of diarrhea\* 6. Episode of C. difficile infection, non-severe or severe uncomplicated. 7. Within 120 hours of receiving standard therapy (oral vancomycin or fidaoxmicin). 8. Must be able to provide informed consent in person or electronically, or if not able to have a LAR to provide consent, in person or remotely via virtual or electronic means.	1. At enrollment, presence of any of the following: 1. Hypotension or shock 2. Megacolon or moderate to severe ileus 3. Acute abdomen 4. Admission to intensive care unit 2. Inability to tolerate oral or enteral medication 3. Presence of other known infectious etiology of diarrhea 4. COVID-19 co-infection at the time of CDI diagnosis. 5. Absolute neutrophil count \<500 mcl 6. Within 100 days of hematologic or solid organ transplant 7. Enrollment in another investigational drug trial 8. Current use of alternative treatment for CDI (e.g. antibiotics other than vancomycin or fidaxomicin; IVIg; fecal transplant). 9. On probiotics and not willing to discontinue. 10. Cirrhosis or in participants with ALT \> 3X normal 11. End stage renal disease, unless on dialysis(HD or PD) or creatinine clearance or estimated GFR of \<30mL/min even after adequate hydration 12. Life expectancy of \< 6 months.

Inclusion Criteria

Exclusion 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 18 years and older.
4. Admitted to UVA hospital, or seen as an outpatient, or seen at Carilion hospital.
5. Presence of diarrhea\*
6. Episode of C. difficile infection, non-severe or severe uncomplicated.
7. Within 120 hours of receiving standard therapy (oral vancomycin or fidaoxmicin).
8. Must be able to provide informed consent in person or electronically, or if not able to have a LAR to provide consent, in person or remotely via virtual or electronic means.

1. At enrollment, presence of any of the following:
1. Hypotension or shock
2. Megacolon or moderate to severe ileus
3. Acute abdomen
4. Admission to intensive care unit
2. Inability to tolerate oral or enteral medication
3. Presence of other known infectious etiology of diarrhea
4. COVID-19 co-infection at the time of CDI diagnosis.
5. Absolute neutrophil count \<500 mcl
6. Within 100 days of hematologic or solid organ transplant
7. Enrollment in another investigational drug trial
8. Current use of alternative treatment for CDI (e.g. antibiotics other than vancomycin or fidaxomicin; IVIg; fecal transplant).
9. On probiotics and not willing to discontinue.
10. Cirrhosis or in participants with ALT \> 3X normal
11. End stage renal disease, unless on dialysis(HD or PD) or creatinine clearance or estimated GFR of \<30mL/min even after adequate hydration
12. Life expectancy of \< 6 months.

Contacts and Locations

Study Locations (Sites)

UVA Health Systems

Charlottesville, Virginia, 22903

United States

Carilion Clinic

Roanoke, Virginia, 24014

United States

Collaborators and Investigators

Sponsor: University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-01

Study Completion Date2027-06-30

Study Record Updates

Study Start Date2021-06-01

Study Completion Date2027-06-30

Terms related to this study

Additional Relevant MeSH Terms

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