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Clinical Trial
. 2022 Dec;78(12):1991-2002.
doi: 10.1007/s00228-022-03405-z. Epub 2022 Oct 26.

Oral mannitol for bowel preparation: a dose-finding phase II study

Cristiano Spada #  1 , Giancarla Fiori #  2 , Peter Uebel  3 , Gian Eugenio Tontini  4   5 , Paola Cesaro  1 , Leonardo Minelli Grazioli  1 , Pietro Soru  2 , Ivana Bravi  2 , Carsten Hinkel  3 , Alberto Prada  6 , Dhanai Di Paolo  7 , Tim Zimmermann  8 , Gianpiero Manes  9 , Jean Christophe Valats  10 , Ralf Jakobs  11 , Luca Elli  12 , Marino Carnovali  13 , Giorgio Ciprandi  14 , Franco Radaelli #  7 , Maurizio Vecchi #  15   12
Affiliations
Clinical Trial

Oral mannitol for bowel preparation: a dose-finding phase II study

Cristiano Spada et al. Eur J Clin Pharmacol. 2022 Dec.

Abstract

Background: Successful bowel preparation (BP) for colonoscopy depends on the instructions, diet, the laxative product, and patient adherence, which all affect colonoscopy quality. Nevertheless, there are no laxatives which combine effectiveness, safety, easy self-administration, good patient acceptance, and low cost. However, mannitol, a sugar alcohol, could be an attractive candidate for use in clinical practice if it is shown to demonstrate adequate efficacy and safety.

Aims: The present phase II dose-finding study compared three doses of mannitol (50, 100, and 150 g) to identify the best dose to be used in a subsequent phase III study.

Methods: The Boston Bowel Preparation Scale, caecal intubation rate, adherence, acceptability, and safety profile, including measurement of potentially dangerous colonic gas concentrations (CH4, H2, O2), were considered in all patients. A weighted algorithm was used to identify the best mannitol dose for use in the subsequent study.

Results: The per-protocol population included 60 patients in the 50 g group, 54 in the 100 g group, and 49 in the 150 g group. The 100 g dose was the best as it afforded optimal colon cleansing efficacy (94.4% of patients had adequate BP), adherence, acceptability, and safety, including negligible gas concentrations.

Conclusions: The present study demonstrated that the colon cleansing efficacy and safety of mannitol were dose dependent. Conversely, gas concentrations were not dose dependent and negligible in all patients. Combined evaluation of efficacy, tolerability, and safety, using a weighted algorithm, determined that mannitol 100 g was the best dose for the phase III study.

Keywords: Bowel preparation; Colonoscopy; Dose-finding; Mannitol; Phase II randomized trial.

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Conflict of interest statement

The authors declare no competing interests, but MC and GC are consultants with NTC Italy.

Figures

Fig. 1
Fig. 1
Patients’ disposition (randomized set)
Fig. 2
Fig. 2
Response rates by treatment group (PP population). *A patient has adequate bowel cleansing if Boston Bowel Preparation Scale (BBPS) total score ≥ 6, with a score for each of the three colon segments ≥ 2. In case of at least one sub-score not available (due to the missed completion of the colonoscopy due to inadequate bowel cleansing), the patient was considered not having adequate bowel cleansing. BBPS, Boston Bowel Preparation Scale; CI, confidence interval; PP, per protocol
See this image and copyright information in PMC

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