Clinical Evaluation of a New Reduced Volume Bowel Preparation

A Pilot Monocentric, Open Phase II Study to Investigate the Efficacy and Safety of a New Oral Gut Cleansing Solution ("Low Dose Bowel Prep") in 30 Patients Submitted to Colonoscopy

Monocentric, cleansing evaluation pilot study in patients undergoing colonoscopy.

Open prospective pilot monocentric phase II clinical trial evaluating the therapeutic efficacy of a new "Low Dose Bowel Prep" formulation for gut cleansing prior to colonoscopy.

Thirty patients admitted to the hospital (inpatients) planned to undergo a complete colonoscopy will have gut cleansing with the "Low Dose Bowel Prep" using a one-step intake mode.

Inclusion Criteria:

• male or female, inpatients 18 to 65 years old with indication for complete colonoscopy
• the patient's written informed consent must be obtained prior to inclusion
• willing and able to complete the entire procedure and to comply with study instructions

Exclusion Criteria:

• ileus or toxic megacolon
• intestinal obstruction or perforation
• known of G6PD insufficiency
• history of any colonic surgery
• ischaemic cardiovascular disease
• untreated or uncontrolled arterial hypertension (max >170mmHg, min >100mmHg)
• renal insufficiency (creating above 45µmol/l)
• abnormal laboratory values (clinically significant) for sodium, potassium,chloride, creatinine and hematocrit
• cirrhosis of liver (Child-Pugh grade B or C)
• females who are pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception.
• concurrent participation in an investigational drug study or participation within 30 days of study entry
• subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results or may interfere significantly