Contemporary Clinical Trials Communications (Aug 2022)

Rationale and design of a multicenter, single-group, open-label trial aiming at investigating the effectiveness of elobixibat for loss of defecation desire in patients with chronic constipation

  • Atsushi Yamamoto,
  • Takaomi Kessoku,
  • Kosuke Tanaka,
  • Kota Takahashi,
  • Yuki Kasai,
  • Anna Ozaki,
  • Michihiro Iwaki,
  • Takashi Kobayashi,
  • Tsutomu Yoshihara,
  • Noboru Misawa,
  • Kanji Ohkuma,
  • Akiko Fuyuki,
  • Takuma Higurashi,
  • Kunihiro Hosono,
  • Masato Yoneda,
  • Tomoyuki Iwasaki,
  • Takeo Kurihashi,
  • Machiko Nakatogawa,
  • Ayao Suzuki,
  • Masataka Taguri,
  • Shunsuke Oyamada,
  • Keisuke Ariyoshi,
  • Noritoshi Kobayashi,
  • Yasushi Ichikawa,
  • Atsushi Nakajima

Journal volume & issue
Vol. 28
p. 100958

Abstract

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Background: Approximately 60% of patients with chronic constipation (CC) have a significantly higher rate of loss of defecation desire (LODD). Bile acids are expected to have a restorative effect on defecation desire (DD) because they lower the rectal sensory threshold, which is an objective index of DD. Elobixibat (EXB) specifically inhibits the ileal bile acid transporter/apical sodium-dependent bile acid transporter, which is a transporter involved in the reabsorption of bile acids in the terminal ileum. This study aims to investigate the LODD improvement rate in patients with CC after 4 weeks of EXB treatment. Methods: A total of 40 adult patients with CC who meet the eligibility criteria will be enrolled. Patients will receive oral EXB (10 mg/day) for 4 weeks. A patient diary will be provided daily at 4 weeks after treatment. The primary endpoint will be the percentage LODD improvement at week 4 of the treatment period from week 2 of the observation period using questionnaires. Ethics and dissemination: Ethical approval was obtained from the Yokohama City University Certified Institutional Review Board prior to participant enrolment (approval number: CRB21-008). The results of this study will be submitted for publication in international peer-reviewed journals, and key findings will be presented at international scientific conferences. Participants desiring the results of this study will be directly contacted for data dissemination. Trial registration: This trial was registered at ClinicalTrials.gov (NCT05165199). Protocol version: 1.0, September 21, 2021.

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