Symptomatic diarrhea due to E. histolytica Infections and Infestations
Conditions
Interventions
Participants who meet all eligibility criteria and consent to participation will be randomized to receive either low dose disulfiram (250 mg) daily plus 50 mg zinc gluconate thrice daily x 10 days
high dose disulfiram (500 mg) daily plus 50 mg zinc gluconate thrice daily x 10 days or the active control metronidazole (500 mg) thrice daily x 10 days). Participants will be followed for safety and
Sponsors
University of Florida
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18–65 years inclusive at enrollment in good health, with diarrhea and microbiologically confirmed E. histolytica infection 2. Willing/ able to give informed consent to be enrolled in and comply with trial procedures follow-up 3. Willing to abstain from alcohol ingestion while on therapy through 28 days 4. For females of reproductive potential, agreement to use highly effective contraception through 28 days
Exclusion criteria
Exclusion criteria: 1. Hypotension or shock 2. Intestinal obstruction, including megacolon and moderate to serve ileus 3. Acute abdomen 4. Admitted to hospital or intensive care unit atenrolmentt 5. Inability to tolerate oral medication 6. Other suspected etiology for diarrhea e.g. other enteric pathogen, other intestinal disease 7. Pregnant and/ or breastfeeding women 8. Consumption of alcohol within 48 hours of enrollment 9. History of alcohol or substance use disorder 10. History of psychosis 11. Severe myocardial dysfunction 12. History of chronic liver disease 13. History of end stage renal disease 14. Prolonged prothrombin time 15. Concomitant treatment with theophylline or warfarin 16. Concomitant use of phenytoin 17. Concomitant use of isoniazid 18. Concomitant use of bictegravir, cabotegravir, dolutegravir, or raltegravir 19. Concomitant treatment with prednisone 40 mg or more daily [or equivalent corticosteroid] 20. Exposure to ethylene dibromide 21. History of known sensitivity or allergic reaction to disulfiram 22. History of known sensitivity or allergic reaction to metronidazole or nitroimidazole derivates 23. History of rubber contact dermatitis 24. Concurrent participation in another investigational trial within the previous 30 days 25. Has any condition that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary safety endpoint: The proportion of participants experiencing a grade 3 or greater adverse event during a 10-day course of study treatment Primary efficacy endpoint: The proportion of participants with resolution of diarrhea (no loose stools for 24 hours i.e. Bristol type 6-7) at end of therapy after a 10-day course of study treatment course | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy endpoint: The proportion of participants with negative stool microscopy at end of therapy after a 10-day course of study treatment course | — |
Countries
Philippines
Contacts
Public ContactDebbie-Ann Shirley
Outcome results
None listed