Immuron (ASX:IMC) has updated on the US Department of Defense Uniformed Services University (USU) clinical evaluation of the company's Travelan.
The company said the USU has reported that to date it has recruited 157 participants into the clinical study following the initiation of enrolment. It said USU expects to complete clinical trial enrolment in approximately 18 months.
USU’s Infectious Diseases Clinical Research Program (IDCRP), the UK Ministry of Defense and the New York City Travel Clinic, are jointly conducting the randomised clinical trial to evaluate the efficacy of Travelan and a commercially available probiotic nutraceutical product in travellers’ diarrhea.
The randomised, double-blind, placebo-controlled multicenter clinical trial (P3TD study) is designed to evaluate the effectiveness of Travelan (IMM-124E) passive immunoprophylaxis and Florastor compared to a placebo.
Study participants (1,302 in total) will be randomised to Travelan, Florastor or placebo (434 per arm).
Travellers’ diarrhea (TD) is a highly prevalent disease that impacts the operational readiness of military personnel and is also debilitating civilian travel.
"Current mitigation strategies including pre-travel counselling and antibiotics for prevention and treatment have important limitations, and there are currently no licensed, pathogen-specific vaccines for TD prevention," said Immuron.