Bowel Sounds Analysis in Paediatric Inflammatory Bowel Disease: Relationship With wPCDAI (SONO-MICI)
Primary Purpose
Bowel Sounds, Intestinal Inflammation, Crohn Disease
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Abdominal auscultation
Sponsored by
About this trial
This is an interventional diagnostic trial for Bowel Sounds focused on measuring bowel sounds, Intestinal Inflammation, Crohn Disease
Eligibility Criteria
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)
Sites / Locations
- CHU Amiens
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
paediatric inflammatory bowel disease
Arm Description
Outcomes
Primary Outcome Measures
evaluation of frequency of bowel sounds
evaluation of wPCDAI
wPCDAI is WEIGHTED PAEDIATRIC CROHN'S DISEASE ACTIVITY INDEX
correlation between wPCDAI and frequency of bowel sounds
wPCDAI is WEIGHTED PAEDIATRIC CROHN'S DISEASE ACTIVITY INDEX
Secondary Outcome Measures
Full Information
NCT ID
NCT05955963
First Posted
July 13, 2023
Last Updated
July 13, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT05955963
Brief Title
Bowel Sounds Analysis in Paediatric Inflammatory Bowel Disease: Relationship With wPCDAI
Acronym
SONO-MICI
Official Title
Bowel Sounds Analysis in Paediatric Inflammatory Bowel Disease: Relationship With wPCDAI
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 24, 2021 (Actual)
Primary Completion Date
September 2, 2023 (Anticipated)
Study Completion Date
June 4, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bowel Sounds, Intestinal Inflammation, Crohn Disease
Keywords
bowel sounds, Intestinal Inflammation, Crohn Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
paediatric inflammatory bowel disease
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Abdominal auscultation
Intervention Description
spectral analysis of Bowel sounds
Primary Outcome Measure Information:
Title
evaluation of frequency of bowel sounds
Time Frame
one day
Title
evaluation of wPCDAI
Description
wPCDAI is WEIGHTED PAEDIATRIC CROHN'S DISEASE ACTIVITY INDEX
Time Frame
one day
Title
correlation between wPCDAI and frequency of bowel sounds
Description
wPCDAI is WEIGHTED PAEDIATRIC CROHN'S DISEASE ACTIVITY INDEX
Time Frame
one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bowel Sounds Analysis in Paediatric Inflammatory Bowel Disease: Relationship With wPCDAI
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