Clinical trial NCT04904224: Diagnosis of Inflammatory Bowel Disease by Examining the Entire Bowel by Pan-intestinal Capsule Endoscopy
Official title: Use of Pan-intestinal Capsule Endoscopy for Detection of Inflammatory Bowel Disease in the Case of Increased Fecal Calprotectin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Diseases
Morbus Crohn
Keywords: Abdominal Pain
Diarrhea
Video Capsule Endoscopy
Panintestinal Video Capsule Endoscopy
Fecal Calprotectin
Lead sponsor: Robert Bosch Medical Center
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2021-05-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized multicentric open-label study in cooperation with local gastroenterological specialist practices. A comparison is made of pan-intestinal capsule endoscopy versus colonoscopy.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Evidence of inflammatory Alterations in the Gastrointestinal Tract
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Number of Diagnosis of a Chronic Inflammatory Bowel Disease
timeFrame: through study completion, an average of 1 year
measure: Number of Participants with Indication for a Therapy because of the Examination findings
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Ditzingen
country: Germany
facility: Praxis Gersemann
state: Baden-Württemberg
city: Leonberg
country: Germany
facility: Praxis Escher
state: Baden-Württemberg
city: Stuttgart
country: Germany
facility: Gastroenterologische Schwerpunktpraxis
state: Baden-Württemberg
city: Stuttgart
country: Germany
facility: Robert Bosch Medical Center
state: Baden-Württemberg
city: Stuttgart
country: Germany
facility: Gastroenterologie am Pragsattel
state: Baden-Württemberg
city: Stuttgart
country: Germany
facility: Ambulante Gastroenterologie
state: Baden-Württemberg
Study officials:
affiliation: Robert Bosch Medical Center
name: Joerg G. Albert
role: STUDY_DIRECTOR
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