Bowel Sounds Analysis in Paediatric Inflammatory Bowel Disease: Relationship With wPCDAI
SONO-MICI
1 other identifier
interventional
49
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 24, 2021
CompletedFirst Submitted
Initial submission to the registry
July 13, 2023
CompletedFirst Posted
Study publicly available on registry
July 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2024
CompletedJuly 21, 2023
July 1, 2023
2.2 years
July 13, 2023
July 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
evaluation of frequency of bowel sounds
one day
evaluation of wPCDAI
wPCDAI is WEIGHTED PAEDIATRIC CROHN'S DISEASE ACTIVITY INDEX
one day
correlation between wPCDAI and frequency of bowel sounds
wPCDAI is WEIGHTED PAEDIATRIC CROHN'S DISEASE ACTIVITY INDEX
one day
Study Arms (1)
paediatric inflammatory bowel disease
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Crohn's Disease
- Age between 4 and 17 years
- Follow-up at CHU Amiens-Picardie
You may not qualify if:
- Other diseases than Crohn's or treatments affecting the gastrointestinal tract, recent (\< 3 months) surgery or refusal to participate (parents or children)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Amiens
Amiens, 80054, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2023
First Posted
July 21, 2023
Study Start
June 24, 2021
Primary Completion
September 2, 2023
Study Completion
June 4, 2024
Last Updated
July 21, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share