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

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

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.

Study Overview

• Status: Unknown
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Sodium Picosulfate/Magnesium Citrate Laxative; Drug: 2L polyethylene glycol/ascorbic acid

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ala Sharara, M.D; Phone Number: 00961893989; Email: as08@aub.edu.lb
• Study Contact Backup: Name: Louma Rustam, M.D; Phone Number: 00961952395; Email: lr22@aub.edu.lb

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Recruiting
    • American University of Beirut
    • Contact: Louma Rustam, MD
    • Principal Investigator: Ala Sharara, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Citrafleet®; Patients will receive sodium picosulfate/magnesium citrate (Citrafleet®) solution with an instruction leaflet.	Drug: Sodium Picosulfate/Magnesium Citrate Laxative; ● First arm: Patients will receive sodium picosulfate/magnesium citrate (Citrafleet®) solution with an instruction leaflet.; Other Names: (Citrafleet®)
Active Comparator: MoviPrep®; Patients will receive 2L polyethylene glycol + ascorbic acid (MoviPrep®) solution with an instruction leaflet.	Drug: 2L polyethylene glycol/ascorbic acid; First arm: Patients will receive sodium picosulfate/magnesium citrate (Citrafleet®) solution with an instruction leaflet.; Second arm: Patients will receive 2L polyethylene glycol + ascorbic acid (MoviPrep®) solution with an instruction leaflet.; Other Names: (MoviPrep®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability of the preparation as assessed by a Likert-type scale	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of the preparation as assessed by the Modified Aronchick scale.	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	1 year
Quality of the preparation as assessed by the Boston Bowel Preparation Scale.	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.; = 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.; = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well.; = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.	1 year
Assessment of adherence to protocol	Patients will answer a set of questions in a data collection sheet pertaining to	1 year

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2018
• Primary Completion (Anticipated): July 26, 2020
• Study Completion (Anticipated): July 26, 2020

Study Registration Dates

• First Submitted: March 27, 2018
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (Actual): July 10, 2018

Study Record Updates

• Last Update Posted (Actual): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Protective Agents; Micronutrients; Vitamins; Antioxidants; Cathartics; Picosulfate sodium; Ascorbic Acid; Magnesium citrate; Laxatives
• Other Study ID Numbers: BIO-2017-0434

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No