Biological Therapy in Patients With Inflammatory Bowel Disease

Quality of Life Clinical Trial

Official title:

Biological Therapy in Patients With Inflammatory Bowel Disease :Laboratory ,Endoscopic and Quality of Life Assessment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05599867
• Other study ID #: Amany123
• Status: Not yet recruiting
• Start date: November 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: October 2022
• Source: Assiut University
• Contact: Ahmed M Abu-Elfatth
• Phone: +18677791
• Email: ahmed.abuelfatth[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Inflammatory bowel disease (IBD) is characterised by chronic, relapsing inflammation of the intestinal mucosa and an inability to down regulate the inflammatory immune response once activated. IBD encompasses ulcerative colitis (UC), Crohn's disease (CD) and indeterminate colitis which is not clearly diagnosed as UC or CD. The peak age of onset of IBD is 15 to 30 years, with a second smaller peak occurring between 50 and 70 years of age

Description:

The incidence of IBD is rapidly increasing in newly industrialized countries strongly implicating environmental factors. The pathogenesis of IBD is not fully understood, but key influences are thought to include genetics, environmental factors, immune response, and gut microbiota.It is recognised that the availability of vitamin D is important in regulating gut mucosal immunity; with studies suggesting that vitamin D may affect gut epithelial integrity, innate immune barrier function, and the development and function of T cells The predominant symptoms of IBD are diarrhea, abdominal pain, gastrointestinal bleeding, weight loss, malnutrition and fatigue which can substantially impact a patient's quality of life (QoL), largely due to the psychosocial impact of symptoms. A survey of IBD outpatients found that concerns about loss of bowel control, producing unpleasant odours, achieving their full potential in the workplace, feeling dirty or smelly, and issues with sexual relationships, ranked highly for both UC and CD

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: November 30, 2023
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Any patient who is above age of 18 years old and diagnosed to have IBD (UC and/or CD) and eligible for biological therapy will be recruited in the study.

Exclusion Criteria:

• Patients with IBD who aren't eligible to biological therapy
• Pregnant patients with IBD
• Patients with IBD who are under age of 18 years old
• Patient's refusal

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Quality of Life

Intervention

Behavioral:
• quality of life
to assess quality among patients with patients with IBD

Locations

Country	Name	City	State
Egypt	Ahmed	Al Minya	Alminya

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, Panaccione R, Ghosh S, Wu JCY, Chan FKL, Sung JJY, Kaplan GG. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2017 Dec 23;390(10114):2769-2778. doi: 10.1016/S0140-6736(17)32448-0. Epub 2017 Oct 16. Review. Erratum in: Lancet. 2020 Oct 3;396(10256):e56. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life in patients with IBD after biological therapy	we use The SF-36 form	one year