Bowel Sounds Analysis in Paediatric Inflammatory Bowel Disease: Relationship With wPCDAI

Crohn Disease Clinical Trial

— SONO-MICI  

Official title:

Bowel Sounds Analysis in Paediatric Inflammatory Bowel Disease: Relationship With wPCDAI

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05955963
• Other study ID #: PI2021_843_0018
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 24, 2021
• Est. completion date: June 4, 2024

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The precise and noninvasive evaluation of disease activity among patients with Crohn's disease is not easy, especially for children. It deals with clinical, biological, histological and radiological parameters. Bowel sounds (BS) when evaluated by a stethoscope are modified by several factors including surgery, infection, drugs or intestinal inflammation. These factors can interact on intestinal motricity. There is a direct relationship between gastrointestinal motility and characteristics of BW. The study of BS using a stethoscope is a simple method, although operator dependent and subjective,with a wide inter and intraindividual variability. Some studies among adults showed interest in the spectral analysis of BS to assess gastrointestinal motility. This more precise and reproducible method is not operator dependent. To date, no such study has evaluated the correlation between disease activity and the spectral pattern of BS. of this project is to assess the correlation between disease activity and the spectral pattern of BS in pediatric Crohn's disease.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49
• Est. completion date: June 4, 2024
• Est. primary completion date: September 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

Inclusion Criteria:

• Crohn's Disease
• Age between 4 and 17 years
• Follow-up at CHU Amiens-Picardie

Exclusion Criteria:

• Other diseases than Crohn's or treatments affecting the gastrointestinal tract, recent (< 3 months) surgery or refusal to participate (parents or children)

Related Conditions & MeSH terms

• Crohn Disease
• Inflammation
• Inflammatory Bowel Diseases
• Intestinal Inflammation

Intervention

Other:
• Abdominal auscultation
spectral analysis of Bowel sounds

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluation of frequency of bowel sounds		one day
Primary	evaluation of wPCDAI	wPCDAI is WEIGHTED PAEDIATRIC CROHN'S DISEASE ACTIVITY INDEX	one day
Primary	correlation between wPCDAI and frequency of bowel sounds	wPCDAI is WEIGHTED PAEDIATRIC CROHN'S DISEASE ACTIVITY INDEX	one day