Abstract

The aim of this study was to evaluate short-term outcomes and safety of elobixibat in home-care patients with chronic constipation (CC) and explore the changes in caregiver burden related to bowel management. This multicenter prospective observational study evaluated bowel movement status, defecation-related symptoms, and caregiver burden in home-care patients diagnosed with CC who had hard stools classified as Bristol Stool Form Scale (BSFS) type 1 or 2. Elobixibat was administered to home-care patients once a day for 4 weeks before a meal. The primary endpoint was the proportion of patients with normal stools at week 2 in patients who were able to excrete independently. Secondary endpoints included the proportion of patient with normal stools at week 4, stool consistency, stool frequency, defecation-related symptoms at weeks 2 and 4, caregiver burden at week 4, concomitant laxative use during the study period, and adverse events. Analyses were based on available data at each assessment time point. The proportion of patient with normal stools at week 2 in patients who could excrete independently was 53% (8/15; 95% CI, 30–75%). Weekly defecation frequency significantly increased at week 4 (n = 20, p = 0.02, without multiplicity adjustment) and was associated with potential improvements in defecation-related symptoms (straining, abdominal bloating) and patient satisfaction. The most common adverse event was mild diarrhea (17%), with no new safety signals observed over 4 weeks. The caregiver questionnaire, evaluated in a limited subset of seven respondents, showed preliminary descriptive changes in physical, psychological, and social burdens. This uncontrolled, exploratory observational study suggests that elobixibat was associated with improvements in defecation-related outcomes in home-care patients with CC. However, these findings should be interpreted with caution due to the small sample size and potential confounding from concomitant laxative use. Caregiver burden findings were descriptive and hypothesis-generating and require confirmation in larger, controlled studies.

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