Prevalence of Neuropsychiatric Manifestations in IBD Patients in Upper Egypt

IBD Clinical Trial

Official title:

Prevalence of Neuropsychiatric Manifestations in IBD Patients in Upper Egypt

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04573400
• Other study ID #: IBD and neuropsychiatry
• Status: Not yet recruiting
• Start date: January 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: September 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Estimation of neuropsychiatric symptoms prevalence in IBD patients and their impact on quality of life.

Description:

Crohn's disease (CD) and ulcerative colitis (UC) are the two main types of idiopathic inflammatory bowel disease (IBD), clearly distinct pathophysiological entities. UC, the most common form of IBD worldwide, is a disease of the colonic mucosa only; it is less prone to complications. In contrast, CD is a transmural disease of the gastrointestinal mucosa which can affect the entire gastrointestinal tract . CD and UC should be considered systemic diseases since they are associated with clinical manifestations involving organs outside the alimentary tract. Extraintestinal manifestations involve several organs, and either precede the onset of intestinal manifestations or appear and evolve in parallel with them . Neurologic involvement associated with IBD is frequently underreported. Nevertheless, it is important to quantify the morbidity burden of clinically significant neurologic complications in IBD because early recognition and treatment of neurologic diseases are crucial for preventing major morbidity . Neurologic involvement in IBD as a subgroup of the EIMs may precede the appearance of digestive symptoms or develop after diagnosis of IBD. In addition, neurological symptoms may exacerbate during flare-ups of IBD or evolve independently from intestinal manifestations without responding to treatment provided for the underlying bowel disease.Within (IBD) literature, anxiety and depression symptoms are commonly identified to be associated with increased disease activity and reduced quality of life. Research also indicates that ongoing psychological distress can exacerbate disease activity,] and increase the risk of flare-ups and health care costs. Given this, screening and targeted treatment of neuropsychological conditions in IBD patients are crucial.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: May 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients under the care of the hospital IBD outpatient service and having been diagnosed with IBD, aged over 18 years, and able to complete the examination and questionnaire.

Exclusion Criteria:

• Patients under the age of 18.

Related Conditions & MeSH terms

• IBD

Intervention

Other:
• HADS
The HADS is a 14-item self-report questionnaire assessing levels of anxiety (seven items) and depression (seven items) over the past week. Each question is assessed on a 4-point Likert Scale: "I feel tense or 'wound up'" (0= not at all 3= most of the time). Consistent with recommendations by Bjelland et al cut-off of 8 for each HADS subscale will be used to differentiate normal from mild to severe distress.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (7)

Baumgart DC, Carding SR. Inflammatory bowel disease: cause and immunobiology. Lancet. 2007 May 12;369(9573):1627-40. Review. — View Citation

Benavente L, Morís G. Neurologic disorders associated with inflammatory bowel disease. Eur J Neurol. 2011 Jan;18(1):138-43. doi: 10.1111/j.1468-1331.2010.03095.x. — View Citation

Danese S, Semeraro S, Papa A, Roberto I, Scaldaferri F, Fedeli G, Gasbarrini G, Gasbarrini A. Extraintestinal manifestations in inflammatory bowel disease. World J Gastroenterol. 2005 Dec 14;11(46):7227-36. Review. — View Citation

Graff LA, Walker JR, Bernstein CN. Depression and anxiety in inflammatory bowel disease: a review of comorbidity and management. Inflamm Bowel Dis. 2009 Jul;15(7):1105-18. doi: 10.1002/ibd.20873. Review. — View Citation

Mardini HE, Kip KE, Wilson JW. Crohn's disease: a two-year prospective study of the association between psychological distress and disease activity. Dig Dis Sci. 2004 Mar;49(3):492-7. — View Citation

Mittermaier C, Dejaco C, Waldhoer T, Oefferlbauer-Ernst A, Miehsler W, Beier M, Tillinger W, Gangl A, Moser G. Impact of depressive mood on relapse in patients with inflammatory bowel disease: a prospective 18-month follow-up study. Psychosom Med. 2004 Jan-Feb;66(1):79-84. — View Citation

Porcelli P, Zaka S, Centonze S, Sisto G. Psychological distress and levels of disease activity in inflammatory bowel disease. Ital J Gastroenterol. 1994 Apr;26(3):111-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify prevalence of neurological and psychological conditions associated with IBD.		2021-2022