A Phase 2 interventional study of Alanyl-glutamine in Clostridium Difficile Infection, sponsored by University of Virginia. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-07.
Sponsored by University of Virginia · Phase 2, Interventional, and Treatment
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.
This is a Phase II randomized, placebo-controlled, double-blinded, dose-ranging study to determine optimal effective dose and safety of AQ between 0, 4, 24, and 44 g doses administered orally for ten days concurrent with standard treatment (oral vancomycin at UVa) among first time incident cases of uncomplicated CDI in hospitalized persons age 50 and older. Our hypothesis is that AQ will reduce recurrence (primary outcome) and mortality (secondary outcome) at 60 days post-treatment. Furthermore, we hypothesize that alanyl-glutamine supplementation will be associated with decreased intestinal and systemic inflammation and improvement of intestinal microbial and metabolic profiles. We plan to enroll 260 patients, equally divided into 4 arms. Upon enrollment, participants will be randomized to either receive AQ at 4, 24, or 44 g or placebo (water). Study agent is administered once a day, orally or enterally, if feeding tube is present. Because we are enrolling subjects over a longer period of time, we will utilize block randomization to ensure that relative temporal balance is maintained throughout the trial. Participants will be followed up daily during treatment for adverse event monitoring and weekly for 60 days post-treatment for recurrences and survival. Blood, urine and stool specimens will be collected at days 0, 10 and 70 to assay for markers of inflammation and microbial and metabolic profiling.
The data set utilized for all initial baseline feature and demographic reporting will be the Intention to Treat Analysis Dataset, which will be comprised of all randomized participants. The primary dataset will be a Modified Intention to Treat Analysis Dataset for all endpoints, comprised of all participants who took at least one dose of study intervention (placebo or treatment), regardless of completeness of follow-up outcome data. The Safety Analysis Dataset will be all participants who took at least one dose of study intervention. The Per Protocol Analysis Dataset will be those patients who took at least 9 doses of study intervention for 9 days of the treatment period (10 days). Analysis will utilize ANOVA unless statistically significant differences in the distribution of baseline characteristics or features of non-normality are detected and relevant, at which point contingency utilization of ANCOVA, logistic regression, or other approaches as appropriate will be implemented. Treatment group level rates will be presented as incidence risk ratios relative to the control (placebo) group with 95% confidence intervals.
Safety endpoints will be evaluated on an individual AE by AE event via the DSMB and utilizing summary statistics during treatment and through duration of follow up. Adverse events will be presented by System Organ Class and will include information on start and stop date, severity, projected relationship, expectedness, and outcome and duration (the latter two after the event is considered to have concluded).
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 7 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Alanyl-glutamine, 44g, taken by mouth daily for 10 days.
Drug: Alanyl-glutamine
Alanyl-glutamine, 44g, taken by mouth daily for 10 days
Also known as: alagln
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
Time frame: At day forty
Mortality
Death from any cause at days 40, 70 and 190
Time frame: Up to 6 months after end of treatment
| Milestone | Alanyl-glutamine |
|---|---|
| Started | 7 |
| Completed | 2 |
| Not completed | 5 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Adverse event | 4 |
Day 40 clinical failure - clinical failure includes death or CDI recurrence assessed 40 days post randomization or lack of clinical cure
| Participants | Alanyl-glutamine |
|---|---|
| Number of Participants With Recurrent C. Difficile Infection | 1 |
Death from any cause at days 40, 70 and 190
| Participants | Alanyl-glutamine |
|---|---|
| Mortality | 0 |
Collected over 6 months post randomization.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alanyl-glutamine | 0/7 (0%) | 0/7 (0%) | 4/7 (57.1%) |
| Event | Alanyl-glutamine |
|---|---|
| gastrointestinal symptomsGastrointestinal disorders | 4/7 |
| Age, Categorical(Participants) | Alanyl-glutamine |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 4 |
| >=65 years | 3 |
| Age, Continuous(years) | Alanyl-glutamine |
|---|---|
| Mean | 59.86 (20 to 83) |
| Sex: Female, Male(Participants) | Alanyl-glutamine |
|---|---|
| Female | 6 |
| Male | 1 |
| Race (NIH/OMB)(Participants) | Alanyl-glutamine |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 5 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Alanyl-glutamine |
|---|---|
| United States | 7 |
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