Prevalence of Respiratory Impairment During IBD

NCT04225650 | Unknown DMC

• 1 other identifier: 2019PI164
• Study Type: observational
• Target: 480
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients will be recruited during a routine consultation with a physician in the hepato-gastroenterology department. At the end of the consultation, patients will have to complete the following questionnaire: "European Community Respiratory Health Survey" which allows the screening of patients at risk of chronic respiratory diseases (asthma, COPD, bronchiectasis, emphysema). In the event of a declaration of functional respiratory signs, a consultation with a pulmonologist will be systematically proposed. At the end of this consultation, if the doctor deems it necessary, further investigations will be proposed and/or regular follow-up organised. The main objective of this study is to estimate the prevalence of respiratory symptoms leading to a diagnosis of chronic respiratory disease in patients with inflammatory bowel diseases (IBD) (Crohn's disease and UC). The main criterion for judgement will be the frequency of functional respiratory signs (wheezing, dyspnea, cough, sputum) reported by IBD patients through an adapted self-report questionnaire.

Conditions

Chronic Obstructive Pulmonary Disease; Asthma; Bronchiectasis; Inflammatory Bowel Diseases

Keywords

Chronic Obstructive Pulmonary Disease; Asthma; Epidemiology; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Frequency of functional respiratory signs

  Frequency of functional respiratory signs (wheezing, dyspnea, coughing, sputum) reported by IBD patients

  Through study completion, an average of 6 months

Secondary Outcomes (3)

• Chronic respiratory diseases

  Through study completion, an average of 6 months

• Exacerbations

  Through study completion, an average of 6 months

• Drugs

  Through study completion, an average of 6 months

Interventions

Pulmonology consultation OTHER

In case of functional respiratory signs, a consultation with a pulmonologist will be booked. At the end of this consultation, if the doctor deems it necessary, other investigations will be proposed and/or regular follow-up will be organised.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any adult patient followed for IBD in the hepato-gastroenterology department of the CHRU de Nancy may be eligible.

You may qualify if:

• Diagnosed with IBD (Crohn disease or Ulcerative colitis) between January 1990 and December 2019.
• Consultation in the Hepato-Gastroenterology Department of the CHRU Nancy-Brabois
• Patients who received full information about the research organization and did not object to the use of the data.
• Patients over 18 years of age

You may not qualify if:

• Inability to complete the questionnaire
• Diagnosis of IBD uncertain
• Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code :Pregnant, parturient or breastfeeding mother, Minor person, person who is subject to a legal protection measure
• Unable to express consent
• Persons deprived of their liberty by a judicial or administrative decision,
• Persons under psychiatric care (articles L. 3212-1 and L. 3213-1)

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• University of Lorraine: collaborator

Related Publications (4)

• Baumgart DC, Carding SR. Inflammatory bowel disease: cause and immunobiology. Lancet. 2007 May 12;369(9573):1627-40. doi: 10.1016/S0140-6736(07)60750-8.

  PMID: 17499605 BACKGROUND

• Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Crohn's disease. Lancet. 2017 Apr 29;389(10080):1741-1755. doi: 10.1016/S0140-6736(16)31711-1. Epub 2016 Dec 1.

  PMID: 27914655 BACKGROUND

• Ungaro R, Mehandru S, Allen PB, Peyrin-Biroulet L, Colombel JF. Ulcerative colitis. Lancet. 2017 Apr 29;389(10080):1756-1770. doi: 10.1016/S0140-6736(16)32126-2. Epub 2016 Dec 1.

  PMID: 27914657 BACKGROUND

• Rodriguez-Roisin R, Bartolome SD, Huchon G, Krowka MJ. Inflammatory bowel diseases, chronic liver diseases and the lung. Eur Respir J. 2016 Feb;47(2):638-50. doi: 10.1183/13993003.00647-2015. Epub 2016 Jan 21.

  PMID: 26797027 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Bronchiectasis; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

simon valentin, MD

CONTACT

+33.83.15.70.24; S.VALENTIN@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 13, 2020
• Study Start: May 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: August 1, 2020
• Last Updated: April 15, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share