Tolerability and Efficacy of Sodium Picosulfate/Magnesium Citrate Versus PEG/Ascorbic Acid in Ulcerative Colitis Patients

Phase 4

• Conditions: Ulcerative Colitis
• Interventions: Drug: Sodium Picosulfate/Magnesium Citrate Laxative; Drug: 2L polyethylene glycol/ascorbic acid

• Registration Number: NCT03581149
• Lead Sponsor: American University of Beirut Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-26
• Study First Submitted: 2018-03-27
• Study First Submitted QC: 2018-07-09
• Study First Posted: 2018-07-10
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-18
• Last Update Posted: 2019-09-19
• Primary Completion: 2020-07-26
• Study Completion: 2020-07-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Citrafleet®	Sodium Picosulfate/Magnesium Citrate Laxative	Patients will receive sodium picosulfate/magnesium citrate (Citrafleet®) solution with an instruction leaflet.
MoviPrep®	2L polyethylene glycol/ascorbic acid	Patients will receive 2L polyethylene glycol + ascorbic acid (MoviPrep®) solution with an instruction leaflet.

Primary Outcome Measures

Name	Time	Method
Tolerability of the preparation as assessed by a Likert-type scale	1 year	Patients will answer a data collection sheet with questions regarding their ability to tolerate the preparation without difficulty. We are using a Likert-type scale from 1 to 5, 1 being completely intolerable and 5 being very easily tolerated.

Secondary Outcome Measures

Name	Time	Method
Quality of the preparation as assessed by the Modified Aronchick scale.	1 year	A data collection sheet will be handed to the blinded endoscopist to answer questions related to the quality of the preparation. A description ranging from Poor to Excellent is assigned to the quality of the prepped colon.; Poor - Re-preparation required; large amount of fecal residue precludes a complete examination; Inadequate - Inadequate but examination completed; enough feces or turbid fluid to prevent a reliable examination; less than 90%mucosa seen; Fair - Moderate amount of stool that can be cleared with suctioning permitting adequate evaluation of entire colonic mucosa; more than 90% mucosa seen; Good - Small amount of turbid fluid without feces not interfering with examination; more than 90% mucosa seen; Excellent - Small amount of clear liquid with clear mucosa seen; more than 95% mucosa seen
Quality of the preparation as assessed by the Boston Bowel Preparation Scale.	1 year	A data collection sheet will be handed to the blinded endoscopist to answer questions related to the quality of the preparation. A score ranging from 0 to 3 is assigned to each of the three segments of the colon: Right colon, Mid colon and Left colon. The scores are calculated as follows: 0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.; 1. = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid.; 2. = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well.; 3. = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
Assessment of adherence to protocol	1 year	Patients will answer a set of questions in a data collection sheet pertaining to

Trial Locations

Locations (1)

American University of Beirut; 🇱🇧 Beirut, Lebanon