Evidence map›Paper›PMID 36287232›Full record

Trial reportEuropean journal of clinical pharmacology2022

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

Cristiano Spada, Giancarla Fiori, Peter Uebel, Gian Eugenio Tontini, Paola Cesaro, Leonardo Minelli Grazioli, Pietro Soru, Ivana Bravi, Carsten Hinkel, Alberto Prada and 10 more

Open access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in European journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.6field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 15 citations in OpenAlex.

  1. Bowel Preparation for Colonoscopy: The Patient Point of View.Digestive diseases (Basel, Switzerland) · 2025
    Trial
  2. A noninvasiveAmerican journal of physiology. Endocrinology and metabolism · 2026
    Article
  3. Observational
  4. Article
  5. Article
  6. Evaluating bowel preparation tolerability in IBD: a phase 3Frontiers in gastroenterology (Lausanne, Switzerland) · 2025
    Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 12 institutions in 3 countries.

Cristiano Spada *U.O. Endoscopia Digestiva, Fondazione Poliambulanza - Istituto Ospedaliero, Brescia, Italy.
Giancarla Fiori *Divisione Di Endoscopia, Istituto Europeo Di Oncologia, IRCCS, Milan, Italy.
Peter UebelPraxis Für Gastroenterologie Und Fachärztliche Innere Medizin, Im Haus Der Gesundheit, Ludwigshafen am Rhein, Germany.
Gian Eugenio TontiniDepartment of Pathophysiology and Organ Transplantation, University of Milan, Milan, Italy. gianeugenio.tontini@policlinico.mi.it.
Paola CesaroU.O. Endoscopia Digestiva, Fondazione Poliambulanza - Istituto Ospedaliero, Brescia, Italy.
Leonardo Minelli GrazioliU.O. Endoscopia Digestiva, Fondazione Poliambulanza - Istituto Ospedaliero, Brescia, Italy.
Pietro SoruDivisione Di Endoscopia, Istituto Europeo Di Oncologia, IRCCS, Milan, Italy.
Ivana BraviDivisione Di Endoscopia, Istituto Europeo Di Oncologia, IRCCS, Milan, Italy.
Carsten HinkelPraxis Für Gastroenterologie Und Fachärztliche Innere Medizin, Im Haus Der Gesundheit, Ludwigshafen am Rhein, Germany.
Alberto PradaServizio Gastroenterologia Ed Endoscopia Digestiva, Istituto Auxologico Italiano, Milan, Italy.
Dhanai Di PaoloU.O.C. Gastroenterologia, Ospedale Valduce, Como, Italy.
Tim ZimmermannKlinikum Worms Medizinische Klinik II, Worms, Germany.
Gianpiero ManesU.O.C. Gastroenterologia, ASST Rhodense, Presidi Di Rho E Garbagnate, Garbagnate Milanese, MI, Italy.
Jean Christophe ValatsHépato-Gastro-Entérologie, Centre Hospitalier Universitaire de Montpellier, Montpellier, France.
Ralf JakobsMedizinische Klinik C, Klinikum der Stadt Ludwigshafen, Ludwigshafen, Germany.
Luca ElliGastroenterology and Endoscopy Unit, IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico, Via F. Sforza 35, 20100, Milan, Italy.
Marino CarnovaliOspedale Papa Giovanni XXIII, Bergamo, Italy.
Giorgio CiprandiCasa Di Cura Villa Montallegro, Genoa, Italy.
Franco Radaelli *U.O.C. Gastroenterologia, Ospedale Valduce, Como, Italy.
Maurizio Vecchi *Department of Pathophysiology and Organ Transplantation, University of Milan, Milan, Italy.
European Institute of Oncology · ITFondazione Poliambulanza Istituto Ospedaliero · ITOspedale Valduce · ITUniversity of Milan · ITAziende Socio Sanitaria Territoriale RhodenseCasa di Cura Columbus · ITCentre Hospitalier Universitaire de Montpellier · FRFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITIRCCS Istituto Auxologico Italiano · ITKlinikum Ludwigshafen · DEOspedale Papa Giovanni XXIII · ITUniversity of Applied Sciences Worms · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSuccessful 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.

aimsThe 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.

methodsThe Boston Bowel Preparation Scale, caecal intubation rate, adherence, acceptability, and safety profile, including measurement of potentially dangerous colonic gas concentrations (CH

resultsThe 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.

conclusionsThe 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.

Indexed as

CatharticsMannitolAdministration, OralColonoscopyHumansLaxativesCatharticsLaxativesMannitolBowel preparationColonoscopyDose-findingMannitolPhase II randomized trial

Identifiers

PMID36287232
PMCPMC9649514
OpenAlexW4307336955

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.