Alanyl-glutamine Supplementation of Standard Treatment for C. Difficile Infection

NCT02053350 | Terminated Phase 2 Results

• 2 other identifiers: 1757617576 Protocol_Alanyl_Glutami
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to test the efficacy of alanyl-glutamine supplementation in the treatment of C. difficile infection. We hypothesize that alanyl-glutamine when given with standard antibiotic treatment for C. difficile infection will decrease diarrhea, mortality and recurrent disease.

Conditions

Clostridium Difficile Infection

Keywords

Clostridium difficile; glutamine; diarrhea; alanyl-glutamine

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Recurrent C. Difficile Infection

  Day 40 clinical failure - clinical failure includes death or CDI recurrence assessed 40 days post randomization or lack of clinical cure

  At day forty

• Mortality

  Death from any cause at days 40, 70 and 190

  Up to 6 months after end of treatment

Study Arms (1)

Alanyl-glutamine

EXPERIMENTAL

Alanyl-glutamine, 44g, taken by mouth daily for 10 days.

Drug: Alanyl-glutamine

Interventions

Alanyl-glutamine DRUG

Alanyl-glutamine, 44g, taken by mouth daily for 10 days

Also known as: alagln

Alanyl-glutamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult of either gender, 18 years or older, with C. difficile infection (CDI)
• Diarrhea associated with C. difficile positive stool assay
• Within 48 hours of receiving either metronidazole for mild-moderate disease or vancomycin for severe uncomplicated disease
• Admitted in the hospital at the time of enrollment
• Ability to provide informed consent
• Have an understanding of study procedures
• Ability to comply with study procedures for the entire length of the study

You may not qualify if:

• Hypotension or shock
• Megacolon or moderate to severe ileus
• Acute abdomen
• Severe leukocytosis (WBC \> 20,000 cells /µL)
• Admission to intensive care unit on enrollment
• Inability to tolerate oral medication
• Other known etiology of diarrhea (e.g. other enteric pathogen, other intestinal disease)
• Inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis)
• Enrollment in another investigational drug trial
• Currently receiving other alternative treatment for CDI (e.g. antibiotics other than metronidazole or vancomycin; probiotics; immunoglobulin therapy; fecal transplant)
• Pregnancy
• Unavailable for follow-up visits
• Life expectancy of \< 6 months
• Chronic liver disease or in subjects without known liver disease, ALT \> 3x normal
• Chronic kidney disease or in subjects without known kidney disease, estimated Creatinine clearance of \< 30 ml/min, even after rehydration

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Clostridium Infections; Diarrhea

Interventions

alanylglutamine

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Cirle Warren
• Organization: UVirginia

CA6T@hscmail.mcc.virginia.edu

(434) 924-5242

Study Officials

• Cirle A. Warren, M.D.

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Medicine, Infectious Disease

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: February 3, 2014
• Study Start: April 1, 2015
• Primary Completion: April 5, 2017
• Study Completion: April 5, 2017
• Last Updated: June 7, 2022
• Results First Posted: June 7, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)