Virtual Clinical Trials in IBS
Irritable bowel syndrome is a highly prevalent condition that affects the digestive system. There is no common cause for all the cases and they can vary from intestinal flora disbalance due to intoxication, to over-sensitive nerves in the gut, or stress.
Symptoms are stomach cramps, bloating, gas, diarrhoea and/or constipation. These tend to come and go over time, and can last for days, weeks or months at a time. IBS is a chronic condition for which no cure exists yet.
At Healint, our objective is to improve the life of people who suffer. One of the ways to reach this goal is to accelerate the reach to market of new medications. The endpoints classically used in clinical trials for IBS are Patient Reported Outcomes. Patient complete a daily e-diary on their own device via our HeRO™ data collection module.
We run the major scales used to assess the efficacy of a new treatment in IBS (see below). We of course, also provide an e-diary for the patient to collect all the secondary endpoints of a clinical trial reported by the patients, such as the daily abdominal discomfort, bloating, number of bowel movements per day.
Abdominal pain
(PRO)
Daily worst pain, weekly average pain, monthly frequency… depending on the objective and the design of the study, pain level can be assessed on different schedules. Patients complete a daily e-diary on their own device via our HeRO™ data collection module to report the level of pain they experienced on each day, when it was at its worst. Results can be interpreted longitudinally, they can be on the responder rate, with a predefined criteria to be considered as responder.
BSS
(PRO)
The Bristol Stool Scale is a stool consistency score completed daily and/or after each bowel movement. It is appropriate for the IBS-D (diarrhea). Often used as a composite endpoint together with the previous one.
SBM
(PRO)
Spontaneous bowel movement. This scale is used in the IBS-C (constipation) and defines the number of bowel movements that occur in the absence of laxatives. We record it as an e-diary once or twice daily. Patients use our HeRO™ module to record this parameter on their own device.