Oral mannitol for bowel preparation: a dose-finding phase II study.
Cristiano Spada1, Giancarla Fiori2, Peter Uebel3
1U.O. Endoscopia Digestiva, Fondazione Poliambulanza - Istituto Ospedaliero, Brescia, Italy.
European Journal of Clinical Pharmacology
|October 26, 2022
Summary
Mannitol at 100g provides effective and safe bowel preparation for colonoscopy, showing optimal efficacy and patient acceptance. This dose was identified as the best for future studies.
Area of Science:
- Gastroenterology
- Clinical Pharmacology
Background:
- Effective bowel preparation (BP) is crucial for colonoscopy quality.
- No current laxative offers optimal effectiveness, safety, and patient acceptance.
- Mannitol, a sugar alcohol, is a potential candidate for improved BP.
Purpose of the Study:
- To determine the optimal dose of mannitol for colonoscopy.
- This phase II study compared 50g, 100g, and 150g of mannitol.
Main Methods:
- Evaluated Boston Bowel Preparation Scale, caecal intubation, adherence, and safety.
- Measured colonic gas concentrations (CH4, H2, O2).
- Utilized a weighted algorithm to select the best mannitol dose.
Main Results:
- The 100g mannitol dose demonstrated optimal colon cleansing efficacy (94.4% adequate BP).
- This dose also showed superior adherence, acceptability, and safety.
- Gas concentrations were negligible and not dose-dependent across all groups.
Conclusions:
- Mannitol's colon cleansing efficacy and safety are dose-dependent.
- The 100g dose of mannitol is recommended for phase III studies.
- Mannitol offers a safe and effective option for bowel preparation.
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