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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01607099
Recruitment Status : Completed
First Posted : May 28, 2012
Last Update Posted : November 14, 2014
Information provided by (Responsible Party):
Technische Universität München

Brief Summary:

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 or disease Intervention/treatment Phase
Laxative Compatibility Procedure: Compatibility Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
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
Study Start Date : September 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Colon cleanness [ Time Frame: From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01607099

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Technische Universität München
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
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Principal Investigator: Peter Klare, MD Technische Universität München
Study Director: Wolfgang Huber, MD Technische Universität München
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Responsible Party: Technische Universität München Identifier: NCT01607099    
Other Study ID Numbers: PicoPrep
First Posted: May 28, 2012    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: November 2014
Keywords provided by Technische Universität München:
bowel cleansing
bowel cleanness