Diagnosis of Inflammatory Bowel Disease by Examining the Entire Bowel by Pan-intestinal Capsule Endoscopy (PEC)

May 22, 2021 updated by: Jorg G. Albert, Robert Bosch Medical Center

Use of Pan-intestinal Capsule Endoscopy for Detection of Inflammatory Bowel Disease in the Case of Increased Fecal Calprotectin

The aim of this study is to discover inflammatory changes in the gastrointestinal tract in adult patients with suspicion of a chronic inflammatory bowel disease (IBD) by examining the entire bowel, including the small intestine, by using a video capsule. The study compares the video capsule endoscopy with colonoscopy with the question of inflammation and patient satisfaction with the respective examinations.

The study is aimed at participants who present to a gastroenterologist because of their complaints like persistent abdominal pain or diarrhea. An infectious genesis and celiac disease must be ruled out in advance.

In addition, the determination of the fecal calprotectin (fCal) is necessary for this study. Fecal calprotectin is a stool marker for the severity of an inflammation of the gastrointestinal tract, an increased fecal calprotectin can be an initial indication for the presence of a chronic inflammatory bowel disease.

As mentioned above, participants will be examined in one of two ways: either with an examination of the small and large intestines using video capsule endoscopy in one examination (i.e. ,panintestinal capsule endoscopy', PICE) or a colonoscopy is performed as the standard treatment. Which of the two methods is used will be decided by lot, electronically controlled.

Colon cleansing is necessary in preparation for both examinations. The advantage of being assigned to the video capsule group is, in addition to showing the entire intestine in one examination, that no sedation is necessary for this examination.

In addition to the examination, participants have to fill out a questionnaire with information about their state of affairs, their well-being and their experience with the examination. After a period of six month the participants will be contact by phone to inquire about their current state of health.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

People who contact a gastroenterologist because of persistent complaints like abdominal pain or diarrhea are suspicious having an inflammatory bowel disease and maybe meet the eligibility requirements for the study.

After checking the inclusion and exclusion criteria further necessary data (medical history, secondary diagnoses, previous examinations, etc.) as well as laboratory parameters (especially signs of inflammation and fecal calprotectin) are collected. After being informed about the study and potential risks, all patients giving written informed consent and who meet the eligibility requirements will be randomized in an open-label manner (participant and investigator) in a 1:1 ratio to video capsule endscopy intervention or colonoscopy. A follow-up by phone to evaluate the state of health is planned after six months.

The study center and established specialist practices are responsible for the study inclusion.

There will be no recruitment by advertising. Only participants who are introducing themselves due to complaints are offered study participation.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Baden-Württemberg
      • Ditzingen, Baden-Württemberg, Germany, 71254
        • Recruiting
        • Praxis Gersemann
        • Contact:
          • Michael Gersemann
      • Leonberg, Baden-Württemberg, Germany, 71229
        • Recruiting
        • Praxis Escher
        • Contact:
          • Markus Escher
      • Stuttgart, Baden-Württemberg, Germany, 70190
        • Recruiting
        • Gastroenterologische Schwerpunktpraxis
        • Contact:
          • Boris Uhel
        • Contact:
          • Hartmut Goelkel
        • Sub-Investigator:
          • Hans-Michael Haemmerle
      • Stuttgart, Baden-Württemberg, Germany, 70376
        • Recruiting
        • Robert Bosch Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bea Poppel
      • Stuttgart, Baden-Württemberg, Germany, 70469
        • Recruiting
        • Gastroenterologie am Pragsattel
        • Contact:
          • Oliver Mueller
        • Contact:
          • Marcus Pichler
      • Stuttgart, Baden-Württemberg, Germany, 70565
        • Recruiting
        • Ambulante Gastroenterologie
        • Contact:
          • Karl M. Teubner
        • Contact:
          • Dietmar Vogler
        • Sub-Investigator:
          • Albrecht G. Maier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older

  • Apply one of the following

    • Chronic abdominal pain for at least 4 weeks, min. 3/10 points on a visual pain scale
    • Persistent diarrhea, Stool frequency of at least 4 per day
    • doctor visit due to the mentioned complaints
  • Exclusion of an infectious genesis or coeliac disease by serological testing or duodenal biopsy, if necessary
  • Consent to study participation
  • Fecal calprotectin > 50 µg/g

Exclusion Criteria:

  • Pregnancy
  • metastasized malignoma
  • terminal renal insufficiency, renal insufficiency requiring dialysis
  • swallowing disorder
  • age < 18 years
  • lack of consent
  • infectious genesis of symptomps
  • coeliac disease

  • Relative contraindication:

    • evidence of strictures, strictures or fistulas in the gastrointestinal tract in imaging or in high suggestive symptoms, e.g. Ileus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PICE
Participants receive a panintestinal video capsule endoscopy (PICE)
Device: Panintestinal video capsule endoscopy
Performing a video capsule endoscopy using the Pill Cam Crohn's capsule from Medtronic
Other Names:
  • PillCam Crohn's Capsule
Active Comparator: Colonoscopy
Participants receive an (Ileo-)Colonoscopy
Device: Colonoscopy
Performing a standard colonoscopy using the colonoscope available in the study center
Other Names:
  • (Ileo-)Colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Evidence of inflammatory Alterations in the Gastrointestinal Tract
Time Frame: through study completion, an average of 1 year
Detection of inflammatory changes using vidoe capsule endoscopy or colonoscopy
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Diagnosis of a Chronic Inflammatory Bowel Disease
Time Frame: through study completion, an average of 1 year
Diagnosis of inflammatory bowel disease depending on the examination findings of video capsule endoscopy or colonoscopy
through study completion, an average of 1 year
Number of Participants with Indication for a Therapy because of the Examination findings
Time Frame: through study completion, an average of 1 year
Indication for a surgical or drug therapy
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert Bosch Medical Center

Collaborators

Medtronic

Investigators

  • Study Director: Joerg G. Albert, Robert Bosch Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2021

Primary Completion (Anticipated)

March 31, 2022

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

May 22, 2021

First Submitted That Met QC Criteria

May 22, 2021

First Posted (Actual)

May 27, 2021

Study Record Updates

Last Update Posted (Actual)

May 27, 2021

Last Update Submitted That Met QC Criteria

May 22, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KKF-06-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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