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

NCT ID: NCT03581149

Last Updated: 2019-09-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-26
• Study Completion Date: 2020-07-26

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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Citrafleet®

Patients will receive sodium picosulfate/magnesium citrate (Citrafleet®) solution with an instruction leaflet.

Group Type: ACTIVE_COMPARATOR

Sodium Picosulfate/Magnesium Citrate Laxative

Intervention Type: DRUG

● First arm: Patients will receive sodium picosulfate/magnesium citrate (Citrafleet®) solution with an instruction leaflet.

MoviPrep®

Patients will receive 2L polyethylene glycol + ascorbic acid (MoviPrep®) solution with an instruction leaflet.

Group Type: ACTIVE_COMPARATOR

2L polyethylene glycol/ascorbic acid

Intervention Type: DRUG

• 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.

Interventions

Sodium Picosulfate/Magnesium Citrate Laxative

● First arm: Patients will receive sodium picosulfate/magnesium citrate (Citrafleet®) solution with an instruction leaflet.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

(Citrafleet®); (MoviPrep®)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ala'a Sharara, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

American University of Beirut

Beirut, , Lebanon

Site Status: RECRUITING

Countries

Lebanon

Central Contacts

Ala Sharara, M.D

Role: CONTACT

as08@aub.edu.lb

00961893989

Louma Rustam, M.D

Role: CONTACT

lr22@aub.edu.lb

00961952395

Facility Contacts

Louma Rustam, MD

Role: primary

Other Identifiers

BIO-2017-0434

Identifier Type: -

Identifier Source: org_study_id