Obscure gastrointestinal bleeding. Inflammatory bowel disease as Crohn's disease. Tumors of the small intestine. Hereditary polyposis syndrome (familial adenomatous polyposis or Peutz-Jeghers Syndrome). Celiac disease. Intestinal lymphoma. Chronic abdominal pain with other symptoms associated and elevated calprotectin >100-150 mcg. MedDRA version: 20.0 Level: LLT Classification code 10078598 Term: Small bowel capsule endoscopy System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Aero-red 100 mg/ml gotas orales en solución
Product Name: Aero-red 100 mg/ml gotas orales en solución
Product Code: 39560
Pharmaceutical Form: Solution for use in drinking water/milk
Pharm
Sponsors
Universitary Hospital Príncipe de Asturias
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients older than 18 years old who have been prescribed a study of small bowel through capsule endoscopy and its cause is encompassed in habitual clinical practice. • Signed informed consent form for the study with capsule endoscopy. • Signed informed consent form for the inclusion in the clinical trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 86 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 86
Exclusion criteria
Exclusion criteria: • Suspicion or diagnosis of intestinal obstruction/perforation. • Small bowel stenosis. • Serious gastroparesis. • Is a study with Patency® capsule has been previously done: retention or expulsion of deform capsule • Pregnant women. • Patients with serious hepatic or cardiovascular or renal disease where use of Moviprep® is contraindicated. • Patients with adverse drug reactions or allergies of polyethylene glycol or simeticone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate and to compare degree of cleanliness and visualization of small bowel mucosal in patients who have been treated with small bowel capsule endoscopy. This comparison will be done among three groups of bowel preparations: •Clear liquid diet in previous day of the exam and fasting as only intervention. •Clear liquid diet and two litres of polyethylene glycol in previous day of the exam and fasting •Clear liquid diet in previous day of the exam and fasting associated to 2mL (200mg) of simeticone 15 minutes before the exploration.;Secondary Objective: •To establish if the findings of significant clinical injuries (diagnostic yield) of small bowel capsule endoscopy is increased due to the preparation use. •To quantify gastric transit time among different preparations. •To quantify small bowel transit time among different preparations. •To evaluate the tolerability and acceptation of different preparations by patients. •To quantify the percentage of completed studies.;Primary end point(s): Degree of cleanliness of small bowel using an accepted cleanliness scale.;Timepoint(s) of evaluation of this end point: During the endoscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • diagnostic yield of small bowel capsule endoscopy • Gastric transit time • Small bowel transit time • Tolerability of preparation • Percentage of completed studies;Timepoint(s) of evaluation of this end point: During the endoscopy. | — |
Countries
Spain
Contacts
Public ContactClinical Trial Information
Hospital Universitario Príncipe de Asturias
Outcome results
None listed