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Sodium Picosulfate Plus Magnesium Citrate Versus Macrogol 4000 in the Bowel Cleansing Procedure: a Comparison of Efficiency and Compatibility

This study has been completed.
Information provided by (Responsible Party):
Technische Universität München Identifier:
First received: May 24, 2012
Last updated: November 13, 2014
Last verified: November 2014

For effective cleansing of the bowel prior to colonoscopy polyethylene glycol (e.g. macrogol) has widely been used in Germany. Usually patients have to drink between 4 an 6 liter of macrogol in a split dose (3 liter on the day before and 1 to 3 liter on the of the examination). One handicap of using polyethylene glycol is the occurence of nausea and vomiting which is due to the high amount of the laxativ and its bad taste. Therefore in a pilot study the investigators have detected a high fraction of patients who consider the cleansing procedure wich macrogol as "very distressing". Thus patient acceptance of the colonoscopy procedure altogether is low.

Since a few month sodium picosulfate/magnesium citrate is available for bowel cleansing in Germany. This preparation tastes better and needs less fluid intake. Usually 150 ml of sodium picosulfate/magnesium citrate are given twice within a 12 hour interval. Patients are instructed to drink plenty of water in addition to the laxative. In the mentioned pilot study the investigators found the cleansing procedure with picosulfate/magnesium citrate to be much more compatible compared to the macrogol regime. The effectiveness expressed by the cleanness of the bowel was equal in both groups.

The investigators believe that a new protocol which contains sodium picosulfate/magnesium citrate instead of macrogol will benefit the patients by fewer abdominal side effects while cleanness of the bowel at the same time will be warranted. This presumption is the reason for the present study.

Condition Intervention
Laxative Compatibility Procedure: Compatibility

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Sodium Picosulfate Plus Magnesium Citrate Versus Macrogol 4000 in the Bowel Cleansing Procedure: a Comparison of Efficiency and Compatibility

Resource links provided by NLM:

Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Valuation "very distressing" [ Time Frame: Just before colonoscopy up to 4 hours afterwards (0 to aprox 4 hours) ]
    Patients will fill in a report in which they rate the stress triggered by the bowel cleansing procedure. The level ranges from 1 to 10 points. Valuations from 8 to 10 points will be considered as very distressing.

Secondary Outcome Measures:
  • Colon cleanness [ Time Frame: From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h ]

Enrollment: 220
Study Start Date: September 2012
Study Completion Date: November 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pico Prep
Arm in which sodium- picosulfate/magnesium citrate is used for bowel cleansing
Procedure: Compatibility
Patients asses the compatibility of the bowel cleansing procedure
No Intervention: Standard
The standard drug macrogol is used for bowel cleansing


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age >= 18
  • Scheduled for colonoscopy

Exclusion Criteria:

  • No informed consent
  • ASA IV or V
  • Pregnancy
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Please refer to this study by its identifier: NCT01607099

Technische Universität München
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Principal Investigator: Peter Klare, MD Technische Universität München
Study Director: Wolfgang Huber, MD Technische Universität München
  More Information

Responsible Party: Technische Universität München Identifier: NCT01607099     History of Changes
Other Study ID Numbers: PicoPrep
Study First Received: May 24, 2012
Last Updated: November 13, 2014

Keywords provided by Technische Universität München:
bowel cleansing
bowel cleanness

Additional relevant MeSH terms:
Citric Acid
Magnesium citrate
Picosulfate sodium
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents processed this record on September 19, 2017