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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until 60 days post-treatment
Awards & highlights

ACT Trial 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.Check my eligibility
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.See study design
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.

ACT Trial Eligibility Criteria

Inclusion Criteria

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

ACT Trial 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

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

ACT 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?

University of VirginiaLead Sponsor
754 Previous Clinical Trials
1,244,813 Total Patients Enrolled
Imperial College LondonOTHER
991 Previous Clinical Trials
14,908,714 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what therapeutic purposes is Alanyl-glutamine typically prescribed?

"Alanyl-glutamine is a popular remedy for osteoporosis, though it can also be prescribed to assist with other medical needs such as nutrition deficits and high metabolic rate."

Answered by AI

Are new participants being admitted to this research endeavor?

"Affirmative. According to clinicaltrials.gov, this investigation is presently recruiting participants who will be sourced from 1 medical centre. The original post date was June 1st 2021 and the most recent update was November 2nd 2022 with a desired sample size of 260 people."

Answered by AI

What criteria do potential participants have to meet in order to qualify for this trial?

"This medical research is seeking 260 individuals with diarrhea, aged between eighteen and one-hundred five. To be eligible for this trial, participants must supply a valid informed consent form; identify as male or female; have recently experienced diarrhoea* within 96 hours of receiving standard therapy (oral vancomycin at UVA); agree to abide by all study conditions throughout the duration of the trial; currently be admitted in hospital due to C. difficile infection that is either non-severe or uncomplicated; and provide their own informed consent in person electronically - unless they are unable to do so, then someone else can act on"

Answered by AI

To what extent have other experiments confirmed the potential of Alanyl-glutamine?

"Presently, there are 5 operational trials that involve Alanyl-glutamine. One of these is in its third phase clinical trial stage and eight medical centres based in San Antonio, Texas are administering the investigations."

Answered by AI

Has Alanyl-glutamine obtained governmental authorization for public utilization?

"According to our assessment, Alanyl-glutamine's safety was rated a 2. This is because the Phase 2 trial has not produced evidence of efficacy yet, but there are several studies which confirm its safety."

Answered by AI

How many participants have been recruited for the trial thus far?

"Affirmative. Clinicaltrials.gov provides evidence that recruitment for this clinical trial is ongoing; it was initially published on June 1st 2021 and was last modified on November 2nd 2022. 260 test subjects are desired from a single medical centre."

Answered by AI

Is enrollment restricted to those over 65 years old for the experiment?

"This medical trial requires that patients applying for the study are between 18 and 105 years old. For those under 18, there are 225 applicable studies available; conversely, 663 trials exist for individuals over 65."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)
Cirle Warren, MD 2021. "Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04305769.
~126 spots leftby Dec 2026
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