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

Q: Who can participate in NCT04305769?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT04305769?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

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

Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT) (NCT04305769) is a Phase 2 interventional studying Clostridioides Difficile Infection and Clostridium Difficile Infection, sponsored by University of Virginia. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Clostridioides Difficile Infection and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 260 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Clostridioides Difficile Infection subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Provision of signed and dated willing to sign a consent form 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 willing to sign a consent form in person or electronically, or if not able to have a LAR to provide consent, in person or remotely via virtual or electronic means. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Alanyl-glutamine

The study agent is AQ, a dipeptide with a glutamine amino group joined to an alanyl residue. It has the following chemical structure: C8H15N3O4. It is a non-animal product available in the form of white crystals or crystalline powder. It is odorless, tasteless, stable and highly soluble.

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

UVA Health Systems

Charlottesville, Virginia, United States

Carilion Clinic

Roanoke, Virginia, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04305769), the sponsor (University of Virginia), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04305769 clinical trial studying?

Who can participate in NCT04305769?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04305769?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04305769. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04305769. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.