Clinical trial NCT03581149: Tolerability and Efficacy of Sodium Picosulfate/Magnesium Citrate Versus PEG/Ascorbic Acid in Ulcerative Colitis Patients
Official title: Tolerability and Efficacy of Low-Volume Sodium Picosulfate/Magnesium Citrate Versus 2L Polyethylene Glycol/Ascorbic Acid in Patients With Ulcerative Colitis Undergoing Colonoscopy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ulcerative Colitis
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Ulcerative colitis is a chronic condition that results in the inflammation of the colon and rectum. Patients suspected to have ulcerative colitis are diagnosed via colonoscopy. Moreover, colonoscopy is considered to be the preferred procedure for assessing the activity and extent of the disease, as well as monitoring treatment response and development of lesions. Therefore, optimal performance and visualization of mucosal lesions via adequate bowel preparation is essential in such patients. In addition, the nature of the disease and the need for multiple colonoscopies throughout a patient's lifetime makes compliance to repeated procedures difficult.

It is well known that colonoscopy preparations are generally poorly tolerated, disliked and, consequently serve as an additional burden on patients.Polyethylene glycol (PEG), despite being the golden standard, is not very well tolerated. Inadequate bowel preparations are associated with cancelled procedures, prolonged procedure time, incomplete examination, increased cost and possibly complications, physician frustration and patient anxiety, but most importantly, with missed pathology. A good bowel preparation would need a solution with reasonable volume, acceptable taste, minimal diet restrictions, and easy-to-follow instructions. The strict need for adherence to drinking a relatively large volume of solution preparation may result in poor compliance.

Despite the emergence of several types of low volume preparations, the evidence on the use of such solutions remains sparse. This is especially true in terms of patients' tolerability to the solution, and its relation with adequate bowel preparation during colonoscopy.

The investigator's aim is to assess how small volume preparations such as sodium picosulfate/magnesium citrate (Citrafleet®) enhance participants tolerability to the solution, compliance, and adequacy of bowel preparations when compared to 2L polyethylene glycol + ascorbic acid (MoviPrep®) in patients with Ulcerative Colitis.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Ulcerative Colitis
* Patients undergoing elective outpatient colonoscopy
* Patients consenting to the study

Exclusion Criteria:

* Age less than 18 years
* Pregnant or lactating women
* Significant gastroparesis
* Gastric outlet obstruction
* Ileus
* Known or suspected bowel obstruction or perforation
* Phenylketonuria
* Toxic colitis or megacolon
* Having a stoma
* Compromised swallowing reflex or mental status
* Psychiatric disease or known or suspected poor compliance
* Severe chronic renal failure (creatinine clearance \<30 mL/minute)
* Severe congestive heart failure (New York Heart Association \[NYHA\] class III or IV)
* Dehydration
* Laxative use or dependency
* Chronic constipation (\<3 spontaneous bm/week)
* Uncontrolled hypertension (systolic blood pressure ≥170 mm Hg, diastolic blood pressure ≥100 mm Hg)
* Prior colon resection
* Age above 65 years
* Profusely bleeding patients with severe UC

Primary outcomes:
measure: Tolerability of the preparation as assessed by a Likert-type scale
timeFrame: 1 year
Secondary outcomes:
measure: Quality of the preparation as assessed by the Modified Aronchick scale.
timeFrame: 1 year
measure: Quality of the preparation as assessed by the Boston Bowel Preparation Scale.
timeFrame: 1 year
measure: Assessment of adherence to protocol
timeFrame: 1 year
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut
Study officials:
References: