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Amino Acid

Alanyl-glutamine for Clostridium Difficile Infection (ACT Trial)

Phase 2
Recruiting
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of diarrhea*
Episode of C. difficile infection, non-severe or severe uncomplicated
Must not have
At enrollment, presence of any of the following: Hypotension or shock, Megacolon or moderate to severe ileus, Acute abdomen, Admission to intensive care unit, Inability to tolerate oral or enteral medication, Presence of other known infectious etiology of diarrhea, COVID-19 co-infection at the time of CDI diagnosis, Absolute neutrophil count <500 mcl
On probiotics and not willing to discontinue
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until 60 days post-treatment

Summary

This trial is testing whether the supplement alanyl-glutamine can decrease recurrence and mortality from C. difficile infection in hospitalized seniors.

Who is the study for?
This trial is for adults aged 18 or older with a first-time, uncomplicated C. difficile infection who are within 96 hours of receiving standard therapy and can consent to the study. It's not for those with severe conditions like shock, megacolon, acute abdomen, ICU patients, intolerance to oral medication, other diarrhea causes or on conflicting treatments.
What is being tested?
The ACT trial tests different doses (4g, 24g, and 44g) of alanyl-glutamine given orally for ten days alongside standard therapy to see if it reduces recurrence and mortality from C. difficile infections while improving inflammatory markers and gut microbiota function.
What are the potential side effects?
While specific side effects aren't listed here, participants may experience issues related to gastrointestinal health due to the nature of the treatment and underlying condition. Monitoring will occur for any adverse reactions during supplementation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently experiencing diarrhea.
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I have had a mild or severe but straightforward C. difficile infection.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking probiotics and do not want to stop.
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I am currently using treatments other than vancomycin or fidaxomicin for CDI.
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I have cirrhosis or my ALT levels are more than three times the normal range.
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I had a bone marrow or organ transplant within the last 100 days.
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I have severe kidney disease but am on dialysis or my kidney function is very low.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until 60 days post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and until 60 days post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with recurrent CDI.
Secondary study objectives
Number of participants who died post-study treatment

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Alanyl-glutamine 4gExperimental Treatment1 Intervention
Group II: Alanyl-glutamine 44gExperimental Treatment1 Intervention
Group III: Alanyl-glutamine 24gExperimental Treatment1 Intervention
Group IV: Alanyl-glutamine 0gPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Carilion ClinicOTHER
82 Previous Clinical Trials
15,113 Total Patients Enrolled
University of SouthamptonOTHER
227 Previous Clinical Trials
2,466,676 Total Patients Enrolled
University of VirginiaLead Sponsor
785 Previous Clinical Trials
1,316,186 Total Patients Enrolled
Imperial College LondonOTHER
1,040 Previous Clinical Trials
15,026,304 Total Patients Enrolled

Media Library

Alanyl-glutamine (Amino Acid) Clinical Trial Eligibility Overview. Trial Name: NCT04305769 — Phase 2
Clostridium Difficile Infection Research Study Groups: Alanyl-glutamine 4g, Alanyl-glutamine 24g, Alanyl-glutamine 0g, Alanyl-glutamine 44g
Clostridium Difficile Infection Clinical Trial 2023: Alanyl-glutamine Highlights & Side Effects. Trial Name: NCT04305769 — Phase 2
Alanyl-glutamine (Amino Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04305769 — Phase 2
~91 spots leftby Dec 2026
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