Assessment of Combined Bowel Preparation for Capsule Endoscopy Study

NCT01243736 | Completed Phase 1 DMC

• 1 other identifier: 10-000198
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are conducting a study to see if taking a bowel preparation before having a capsule endoscopy is more helpful than the standard preparation of not eating after 7 PM the night before a capsule endoscopy in making it easier to see the small bowel in order to find the source of gastrointestinal bleeding.

Conditions

Gastrointestinal Hemorrhage

Keywords

anemic; bleeding; blood in stool; abdomen pain; Gastrointestinal bleeding; capsule endoscopy (CE)

Outcome Measures

Primary Outcomes (1)

• Improvement small bowel visualization, diagnostic yield, and complete rate of capsule endoscopy

  The primary endpoints of small bowel visualization quality, diagnostic yield, and completion rate will be compared between groups using Pearson's chi-square test.

  1 year

Secondary Outcomes (2)

• Safety outcomes and Patient satisfaction

  1 year

• gastric transit time

  1 year

Study Arms (2)

Standard prep

NO INTERVENTION

One group will receive the standard bowel preparation, which consists of eating no solid foods after 7 p.m. the evening prior to the capsule endoscopy test and being able to consume clear liquids up to 4 hours prior to the capsule endoscopy test

Combination Prep

ACTIVE COMPARATOR

The other group will receive the combination bowel preparation, which consists of taking the standard bowel preparation plus: 1. drinking 2-liters (8 cups) of polyethylene glycol starting at 7 p.m. the night prior to the capsule endoscopy test; 2. drinking a teaspoon of simethicone 20 minutes prior to the capsule endoscopy test; 3. drinking a teaspoon of metoclopramide 20 minutes prior to the capsule endoscopy test; 4. lying on your right side for 30 minutes following the swallowing of the capsule endoscope.

Drug: Combination Prep

Interventions

Combination Prep DRUG

combination bowel preparation, which consists of: 1. drinking 2-liters (8 cups) of polyethylene glycol starting at 7 p.m. the night prior to the capsule endoscopy test; 2. drinking a teaspoon of simethicone 20 minutes prior to the capsule endoscopy test; 3. drinking a teaspoon of metoclopramide 20 minutes prior to the capsule endoscopy test; 4. lying on your right side for 30 minutes following the swallowing of the capsule endoscope.

Also known as: polyethylene glycol, simethicone, metoclopramide

Combination Prep

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old
• Gastrointestinal bleeding as indication for capsule endoscopy.
• Ability to give informed consent

You may not qualify if:

• Subject has an allergy to polyethylene glycol or other adverse reaction to a previous bowel preparation with PEG3350 (MoviPrep®), metoclopramide, or simethicone;
• Subjects has gastrointestinal motility disorder;
• Subjects had stomach or small bowel resection;
• Pregnancy;
• Subjects has pheochromocytoma;
• Subjects has uncontrolled hypertension;
• Subjects has seizure disorders;
• Subjects has concurrent MAO inhibitor use;
• Subject has G6PD deficiency;
• Subjects has swallowing disorder (including impaired gag reflex);
• Subjects has hyponatremia with serum sodium less than 130 mm0l/L

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Hansel SL, Murray JA, Alexander JA, Bruining DH, Larson MV, Mangan TF, Dierkhising RA, Almazar AE, Rajan E. Evaluating a combined bowel preparation for small-bowel capsule endoscopy: a prospective randomized-controlled study. Gastroenterol Rep (Oxf). 2019 Oct 19;8(1):31-35. doi: 10.1093/gastro/goz054. eCollection 2020 Feb.

  PMID: 32419949 DERIVED

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Hemorrhage; Abdominal Pain

Interventions

Polyethylene Glycols; Simethicone; Metoclopramide

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Benzamides; Amides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Officials

• Stephanie L. Hansel, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Elizabeth Rajan, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: November 18, 2010
• Study Start: April 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

US (1)