Low Volume Colon Preparation for IBD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy

NCT01533090

Colonic Polyps Cancer Colon Inflammatory Bowel Disease

COMPLETED NA

1L- vs. 4L-PEG for Bowel Preparation Among Inpatients.

NCT04310332

Colonoscopy Hospitalized Patients Bowel Preparation

COMPLETED

Single Center Comparison of 4 FDA Approved, Commercially Available Bowel Purgatives for Colonoscopy

NCT02124447

Patients Undergoing Screening or Surveillance Colonoscopy

WITHDRAWN NA

Evaluation of a Mixed Bowel Prep (2L PEG + Bisacodyl) Versus PEG With Ascorbate

NCT01509131

Colonoscopy

COMPLETED PHASE4

Low Volume PEG With Low Residue Test Meals Versus High Volume Split-dose PEG Bowel Preparation

NCT01568814

Bowel Preparation Colonoscopy

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammatory Bowel Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

4 Liter PEG

Colon preparation for colonoscopy: PEG 4 Liter before endoscopy

Group Type ACTIVE_COMPARATOR

Colon preparation for colonoscopy

Intervention Type DRUG

Colon cleansing prior to perform colonoscopy

2 Liter PEG plus bisacodil

Colon preparation for colonoscopy: PEG 2 L before endoscopy

Group Type EXPERIMENTAL

Colon preparation for colonoscopy

Intervention Type DRUG

Colon cleansing prior to perform colonoscopy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Colon preparation for colonoscopy

Colon cleansing prior to perform colonoscopy

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Colon cleansing

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

Accepts Healthy Volunteers

No