Anatara Lifesciences will join the ever-growing virtual trial movement with a decentralized clinical study in patients with irritable bowel syndrome who have diarrhea.
The study will be conducted with virtual research organization ObvioHealth. The partnership marks ObvioHealth's entry into the Australian market, building onto its virtual and hybrid trials presence in nearly 30 countries.
The trial will entail patients collecting their data at home with the goal of eliminating the need to do follow-up visits in person at clinics. The patients will record the severity of their IBS-D symptoms alongside other measures such as anticipated relief, quality of life, their adherence to treatment and updates to their health status.
Data plugged into ObvioHealth's phone application goes directly to a platform that is monitored in real time, meaning any issues with sticking to the protocol or possible adverse events can be detected quickly.
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While the trial is meant to be virtual in nature, nurses will still make in-home visits to measure vitals and perform sample collection. Patients can also be assessed at a research center if they prefer.
The study is testing Anatara's gastrointestinal re-programming complementary medicine, or GaRP, which targets the microbiome. The treatment has been tested in preclinical in vitro and in vivo studies.
"It is anticipated that GaRP's mechanism of action will relieve symptoms of IBS-D by reducing inflammation and assisting repair of the gut lining, positively influencing the homeostasis and metabolites of the microbiome. We are pleased to be collaborating with ObvioHealth in undertaking this clinical trial to demonstrate these anticipated benefits following extensive pre-clinical work on the GaRP program," said Steve Lydeamore, Anatara's CEO, in a statement.