Evaluation of small bowel activity in children suspected of inflammatory bowel disease

Evaluation of small bowel activity in children suspected of inflammatory bowel disease - Small bowel activity in children suspected of inflammatory bowel disease

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON32301

Enrollment

Registered

2009-01-08

Start date

2009-02-25

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic inflammation of the gut inflammatory bowel disease

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Patients aged 8-18 years, suspected of IBD who would otherwise be scheduled to undergo an ileocolonoscopy and upper gastrointestinal endoscopy and x-enteroclysis or MRI to confirm or exclude this diagnosis. Patients aged 8-18 years, diagnosed with CD with suspicion of small bowel disease who would otherwise be scheduled to undergo an ileocolonoscopy and upper gastrointestinal endoscopy and x-enteroclysis or MRI to evaluate small bowel disease.

Exclusion criteria

Exclusion criteria: Pregnancy or lactation. Inability to tolerate a 25 second breath-hold.

Design outcomes

Primary

Measure	Time frame
To detect disease activity in the small bowel of children suspected of IBD or diagnosed with CD with suspicion of small bowel disease.	—

Secondary

Measure	Time frame
1. To determine sensitivity and specificity of ultrasound, MRI and WCE compared to enteroscopy with histology in diagnosing IBD. 2. To determine sensitivity and specificity of ultrasound, MRI and WCE compared to enteroscopy with histology in detection of disease activity in the small bowel in IBD. 3. To determine the correlation between disease activity in the small bowel detected by ultrasound, MRI, WCE and enteroscopy with histology with clinical disease activity (PCDAI). 4. To determine the correlation between disease activity in the small bowel detected by ultrasound, MRI, WCE and enteroscopy with histology and laboratory findings (CRP, BSE). 5. To determine patient satisfaction, when undergoing ultrasound, MRI, WCE and enteroscopy. 6. To assess histology of the small bowel in the biopsies taken for the presence of Paneth cells, macrophages, dendritic cells, NKT, T and B lymphocytes and to test immunological cellular response.	—

Measure

Time frame

1. To determine sensitivity and specificity of ultrasound, MRI and WCE compared to enteroscopy with histology in diagnosing IBD. 2. To determine sensitivity and specificity of ultrasound, MRI and WCE compared to enteroscopy with histology in detection of disease activity in the small bowel in IBD. 3. To determine the correlation between disease activity in the small bowel detected by ultrasound, MRI, WCE and enteroscopy with histology with clinical disease activity (PCDAI). 4. To determine the correlation between disease activity in the small bowel detected by ultrasound, MRI, WCE and enteroscopy with histology and laboratory findings (CRP, BSE). 5. To determine patient satisfaction, when undergoing ultrasound, MRI, WCE and enteroscopy. 6. To assess histology of the small bowel in the biopsies taken for the presence of Paneth cells, macrophages, dendritic cells, NKT, T and B lymphocytes and to test immunological cellular response.

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Countries

Netherlands

Outcome results