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

Not Applicable

• Conditions: Morbus Crohn; Inflammatory Bowel Diseases
• Interventions: Device: Panintestinal video capsule endoscopy; Device: Colonoscopy

• Registration Number: NCT04904224
• Lead Sponsor: Robert Bosch Medical Center

Brief Summary

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.

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 Timeline

• Study Start: 2021-03-07
• Status Verified: 2021-05
• Study First Submitted: 2021-05-22
• Study First Submitted QC: 2021-05-22
• Last Update Submitted: 2021-05-22
• Study First Posted: 2021-05-27
• Last Update Posted: 2021-05-27
• Primary Completion: 2022-03-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PICE	Panintestinal video capsule endoscopy	Participants receive a panintestinal video capsule endoscopy (PICE)
Colonoscopy	Colonoscopy	Participants receive an (Ileo-)Colonoscopy

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Praxis Gersemann; 🇩🇪 Ditzingen, Baden-Württemberg, Germany

Gastroenterologische Schwerpunktpraxis; 🇩🇪 Stuttgart, Baden-Württemberg, Germany

Gastroenterologie am Pragsattel; 🇩🇪 Stuttgart, Baden-Württemberg, Germany

Praxis Escher; 🇩🇪 Leonberg, Baden-Württemberg, Germany

Robert Bosch Medical Center; 🇩🇪 Stuttgart, Baden-Württemberg, Germany

Ambulante Gastroenterologie; 🇩🇪 Stuttgart, Baden-Württemberg, Germany