J Neurogastroenterol Motil. 2020 Aug 16. doi: 10.5056/jnm20001. Online ahead of print.

Kyle Staller ¹, Kenneth Barshop ², Christopher Vélez ¹, Abbey Bailey ¹, Joseph J Locascio ³, Elaine Chiquette ⁴, Braden Kuo ¹

Author information

• ¹Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School Boston, MA, USA.
• ²Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA, USA.
• ³Department of Neurology, Massachusetts General Hospital, Boston, MA, USA.
• ⁴Gelesis Inc, Boston, MA, USA.

Abstract

Background/aims: CSP01 is a novel superabsorbent hydrogel that absorbs gastrointestinal fluids and maintains high viscoelastic properties into the colon, where these fluids are released.

Methods: We conducted a 3 week-long single-center, randomized, double-blind, parallel-group, placebocontrolled pilot study comparing change in colonic transit time (CTT) among patients with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) treated for 21 days with either CSP01 hydrogel, active control (carboxymethylcellulose [CMC]) or placebo. CTT was measured using pre-treatment (7 days baseline) and end-of-treatment (last 7 days of treatment) wireless motility capsule transit testing. The primary endpoint was change in CTT.

Results: Forty subjects (20 CSP01; 11 CMC; 9 placebo) were enrolled and 38 completed the study. There was no significant change in mean CTT by treatment group (P = 0.297). In the placebo group, CTT increased by 15.3 minutes between baseline and end of treatment, increased by 366.4 minutes for CMC, and decreased by 727.4 minutes for CSP01. In post hoc analyses among those with CIC, mean CTT decreased by 1079 minutes for CSP01 (P = 0.025 compared to placebo), 919 minutes for CMC (P = 0.117 compared to placebo) and increased by 1113 minutes for placebo. Among patients with IBS-C, there was no significant difference in change in CTT for any treatment group. One subject in the CSP01 arm developed back pain attributed to constipation and withdrew without a second CTT measurement; there were no other adverse events.

Conclusion: CSP01 significantly decreased CTT compared to placebo among patients with CIC, but not IBSC.