NCT04305769 Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)
| NCT ID | NCT04305769 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Virginia |
| Condition | Clostridioides Difficile Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 260 participants in total. It began in 2021-06-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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 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. Exclusion Criteria: 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 • Inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis) or other etiology of non-infectious diarrhea. For patients with history of IBD, allow enrollment if disease is well-controlled and stable (not in flare). 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.
Frequently Asked Questions
Who can join the NCT04305769 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 105 Years, studying Clostridioides Difficile Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04305769 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04305769 currently recruiting?
Yes, NCT04305769 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Virginia to inquire about joining.
Where is the NCT04305769 trial being conducted?
This trial is being conducted at Charlottesville, United States, Roanoke, United States.
Who is sponsoring the NCT04305769 clinical trial?
NCT04305769 is sponsored by University of Virginia. The trial plans to enroll 260 participants.