Intestinal Ultrasound in Pediatric Inflammatory Bowel Disease

Inflammatory Bowel Diseases Clinical Trial

— SPIBDUS  

Official title:

Intestinal Ultrasound Role in the Management of Pediatric Inflammatory Bowel Disease: A Prospective Longitudinal Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03026582
• Other study ID #: SchneiderCMCIsrael
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2023
• Source: Schneider Children's Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Objectives: To assess the predictive value of IUS in children with IBD.

Design: A prospective longitudinal cohort study.

Setting: Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Hospital.

Participants: Children 2 years to 17 years (up to 200 patients) who have been diagnosed with either CD or UC.

Main outcome measures: The changes in bowel wall thickness, assessed by IUS, during 2-year follow-up according to therapeutic regimen.

Secondary outcome measures: Correlation of sonographic measures to clinical disease indices, serum inflammatory and other laboratory markers, fecal calprotectin, endoscopic and other radiologic measures performed as part of routine care.

Description:

Hypothesis:

The investigators hypothesize that bowel wall thickness as measured routinely by IUS has a role in predicting short- and long-term disease outcomes such as flares, hospitalizations, treatment escalation and surgery.

Objectives:

Primary Objectives:

To assess the changes in bowel wall thickness, assessed by IUS, during 2-year follow-up, according to therapeutic regimen and to evaluate its predictive significance on disease outcomes (flares, hospitalizations, treatment escalation and surgery).

Secondary Objective: To evaluate the correlation of sonographic measures to clinical disease indices, serum inflammatory and other laboratory markers, fecal calprotectin, endoscopic and other radiologic measures performed as part of routine care.

Methods:

• Design: A prospective longitudinal cohort study.

• Patients: Children at age 2 year to 17 years diagnosed with IBD.

Intervention:

Children diagnosed with either CD or UC under follow-up at the Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Hospital, will be enrolled. Patients can be enrolled at diagnosis or at any time point during follow-up. Patients' characteristics will be retrieved from their medical files including demographic details, disease phenotype, endoscopic and radiologic variables, anthropometric measures, laboratory evaluation, complication and therapeutic regimens. At enrollment and every 3 months for a total period of 2 years all patients will perform IUS during regular clinic visits. All other measures including laboratory exams, anthropometric measurements and disease activity indices (either wPCDAI for CD or PUCAI for UC) will be performed as part of standard of care and not for the purpose of the study. If endoscopic evaluation or an MRE are necessary according to the treating physician discretion for assessment of disease activity, these will not be performed as part of the study but the results will be recorded and included in the data analysis.

Data analysis:

Data will be analyzed using SPSS (version 23.0, SPSS, Inc., Armonk, NY, USA) and r-project version 3.1.1. Continues variables will be presented as either mean±SD or median with interquartile range (IQR) depending on the data approximation to normal distribution. Agreement between IUS and MRE (when available) will be assessed using Bland-Altman plot and Concurrent Validity quantified by correlation coefficient and concordance correlation coefficient. Associations of therapeutic intervention and other variables with outcome measures will be examined using repeated measures ANOVA. p-values <0.05 is considered significant.

Sample size:

All pediatric IBD patients at Schneider Children's Hospital, fulfilling the inclusion criteria are eligible for the study. For assessment of therapeutic interventions of IUS the investigators will use mixed model ANOVA. Sample size was calculated for repeated measures ANOVA with in-between interactions. Assuming effect size F 0.25 (or partial η2=0.06), an alpha of 5% and statistical power of 80% and a correlation of 0.5, the investigators will need at least 34 CD patients and 34 UC patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 30, 2023
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Diagnosis of IBD

2. Age: 2- 17 years (inclusive)

3. Informed consent

Exclusion Criteria:

1. Pregnancy

2. Morbid obesity

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Device:
• Intestinal ultra-sound monitoring
Children diagnosed with either CD or UC will be enrolled at diagnosis or at any time point during follow-up. Patients' characteristics will be retrieved from their medical files including demographic details, disease phenotype, endoscopic and radiologic variables, anthropometric measures, laboratory evaluation, complication and therapeutic regimens. At enrollment and every 3 months for a total period of 2 years all patients will perform intestinal US during regular clinic visits. All other measures including laboratory exams, anthropometric measurements and disease activity indices (either PCDAI for CD or PUCAI for UC) will be performed as part of standard of care.

Locations

Country	Name	City	State
Israel	Schenider Children's Medical Center	Peta? Tiqwa

Sponsors (1)

Lead Sponsor	Collaborator
Schneider Children's Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bowel wall thickness according to therapeutic regimen		Two years
Secondary	Change in bowel wall thickness in comparison to inflammatory markers		Two years
Secondary	Change in bowel wall thickness in comparison to fecal calprotectin		Two years
Secondary	Change in bowel wall thickness in comparison to pediatric Crohn's disease severity index in Crohn's disease		Two years
Secondary	Change in bowel wall thickness in comparison to pediatric ulcerative colitis activity index in ulcerative colitis		Two years