SONO-MICI: Bowel Sounds Analysis in Paediatric Inflammatory Bowel Disease: Relationship With wPCDAI

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05955963

Collaborator

(none)

Enrollment

Location

Arm

35.4

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bowel Sounds Intestinal Inflammation Crohn Disease	Other: Abdominal auscultation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jun 24, 2021

Anticipated Primary Completion Date :

Sep 2, 2023

Anticipated Study Completion Date :

Jun 4, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: paediatric inflammatory bowel disease	Other: Abdominal auscultation spectral analysis of Bowel sounds

Arm

Intervention/Treatment

Experimental: paediatric inflammatory bowel disease

Other: Abdominal auscultation

spectral analysis of Bowel sounds

Outcome Measures

Primary Outcome Measures

evaluation of frequency of bowel sounds [one day]
evaluation of wPCDAI [one day]
wPCDAI is WEIGHTED PAEDIATRIC CROHN'S DISEASE ACTIVITY INDEX
correlation between wPCDAI and frequency of bowel sounds [one day]
wPCDAI is WEIGHTED PAEDIATRIC CROHN'S DISEASE ACTIVITY INDEX

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)