Low Volume Colon Preparation for IBD

Colon Cleasing for Colonoscopy in Patients With IBD Colitis: Efficacy and Acceptability of 4 Liter PEG vs 2 Liter PEG Plus Bisacodil

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02248337

Enrollment

216

Registered

2014-09-25

Start date

2013-03-31

Completion date

2014-03-31

Last updated

2014-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease

Keywords

Colon preparation; Colonoscopy; Inflammatory bowel disease

Brief summary

Comparison of two PEG-based bowel cleansing regimens in patients with inflammatory bowel disease.

Detailed description

Low-volume preparations are gaining attention for higher acceptability. This study compares efficacy, safety and tolerability of a 2L PEG solution plus bisacodil with a 4L PEG solution in patients with inflammatory bowel disease-related colitis. This will be a multicenter, randomized, single-blind study. Adult outpatients with IBD colitis undergoing colonoscopy will receive either 2L PEG plus biscodil or 4L PEG. Bowel cleansing will be assessed using the Ottawa Scale and rated as adequate if \<6. Patient acceptance, satisfaction, and related symptoms will be also recorded. The study will also focus on the factors affecting quality of preparation in inflammatory bowel disease patients such as disease characteristics and administration regimen

Interventions

DRUGColon preparation for colonoscopy

Colon cleansing prior to perform colonoscopy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

-Adult outpatiets with IBD colitis undergoing colonoscopy

Exclusion criteria

* Previous colon resection, ileus, intestinal obstruction, toxic megacolon, severe heart failure (NYHA Class III or IV), acute cardiovascular disease, uncontrolled arterial hypertension (systolic pressure \>170 mmHg, diastolic pressure \>100 mmHg), severe liver cirrhosis (Child-Pugh score C) or renal failure (creatinine clearance\<30 mL/minute), ascites, phenylketonuria, and glucose-6-phosphate dehydrogenase deficiency * Pregnant or breastfeeding women were also excluded

Design outcomes

Primary

Measure	Time frame	Description
Efficacy	During endoscopy within 24 hours after preparation	Quality of colon cleansing assesse with Ottawa bowel preparation score

Secondary

Measure	Time frame	Description
Compliance	during product assumption	Intake of at least 75% of the product volume
Tollerability	during product assumption	Occurrence of discomfort during drug intake
safety	From drug intake to the end of colonoscopy	Occurrence of side effects

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026