NCT05955963

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 24, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2024

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

2.2 years

First QC Date

July 13, 2023

Last Update Submit

July 13, 2023

Conditions

Keywords

bowel soundsIntestinal InflammationCrohn Disease

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

EXPERIMENTAL
Other: Abdominal auscultation

Interventions

spectral analysis of Bowel sounds

paediatric inflammatory bowel disease

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

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

Locations