CSP01, a Novel Superabsorbent Hydrogel, Reduces Colonic Transit Time in Patients With Chronic Idiopathic Constipation in a Randomized, Double-blind, Controlled Pilot Clinical Trial.
Capsules
Constipation
Gastrointestinal motility
Hydrogels
Irritable bowel syndrome
Journal
Journal of neurogastroenterology and motility
ISSN: 2093-0879
Titre abrégé: J Neurogastroenterol Motil
Pays: Korea (South)
ID NLM: 101530189
Informations de publication
Date de publication:
30 09 2020
30 09 2020
Historique:
received:
03
01
2020
revised:
05
06
2020
accepted:
15
06
2020
pubmed:
19
8
2020
medline:
19
8
2020
entrez:
19
8
2020
Statut:
ppublish
Résumé
CSP01 is a novel superabsorbent hydrogel that absorbs gastrointestinal fluids and maintains high viscoelastic properties into the colon, where these fluids are released. We conducted a single-center, randomized, double-blind, parallel-group, placebo-controlled 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 wireless motility capsule transit testing at pre-treatment and end-of-treatment. The primary endpoint was change in CTT. 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 ( CSP01 significantly decreased CTT compared to placebo among patients with CIC, but not in patients with IBS-C.
Sections du résumé
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 single-center, randomized, double-blind, parallel-group, placebo-controlled 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 wireless motility capsule transit testing at pre-treatment and end-of-treatment. 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 (
Conclusion
CSP01 significantly decreased CTT compared to placebo among patients with CIC, but not in patients with IBS-C.
Identifiants
pubmed: 32807749
pii: jnm20001
doi: 10.5056/jnm20001
pmc: PMC7547195
doi:
Types de publication
Journal Article
Langues
eng
Pagination
496-504Références
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