Trial Outcomes & Findings for Alanyl-glutamine Supplementation of Standard Treatment for C. Difficile Infection (NCT NCT02053350)

NCT ID: NCT02053350

Last Updated: 2022-06-07

Results Overview

Day 40 clinical failure - clinical failure includes death or CDI recurrence assessed 40 days post randomization or lack of clinical cure

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 7 participants
• Primary outcome timeframe: At day forty
• Results posted on: 2022-06-07

Participant Flow

Participant milestones

Measure	Alanyl-glutamine Alanyl-glutamine, 44g, taken by mouth daily for 10 days. Alanyl-glutamine: Alanyl-glutamine, 44g, taken by mouth daily for 10 days
Overall Study STARTED	7
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Alanyl-glutamine Alanyl-glutamine, 44g, taken by mouth daily for 10 days. Alanyl-glutamine: Alanyl-glutamine, 44g, taken by mouth daily for 10 days
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	4

Baseline Characteristics

Alanyl-glutamine Supplementation of Standard Treatment for C. Difficile Infection

Baseline characteristics by cohort

Measure	Alanyl-glutamine n=7 Participants Alanyl-glutamine, 44g, taken by mouth daily for 10 days. Alanyl-glutamine: Alanyl-glutamine, 44g, taken by mouth daily for 10 days
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	59.86 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: At day forty

Population: 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

Outcome measures

Measure	Alanyl-glutamine n=6 Participants Alanyl-glutamine, 44g, taken by mouth daily for 10 days. Alanyl-glutamine: Alanyl-glutamine, 44g, taken by mouth daily for 10 days
Number of Participants With Recurrent C. Difficile Infection	1 Participants

PRIMARY outcome

Timeframe: Up to 6 months after end of treatment

Death from any cause at days 40, 70 and 190

Outcome measures

Measure	Alanyl-glutamine n=7 Participants Alanyl-glutamine, 44g, taken by mouth daily for 10 days. Alanyl-glutamine: Alanyl-glutamine, 44g, taken by mouth daily for 10 days
Mortality	0 Participants

Adverse Events

Alanyl-glutamine

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Alanyl-glutamine n=7 participants at risk Alanyl-glutamine, 44g, taken by mouth daily for 10 days. Alanyl-glutamine: Alanyl-glutamine, 44g, taken by mouth daily for 10 days
Gastrointestinal disorders gastrointestinal symptoms	57.1% 4/7 • Number of events 4 • 6 months post randomization. All AEs including local and systemic reactions not meeting the criteria for "serious adverse events" will be captured on the appropriate CRF. Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product

Additional Information

Dr. Cirle Warren

UVirginia

Phone: (434) 924-5242

Email: CA6T@hscmail.mcc.virginia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place