MedDataX Logo

Biological Therapy in Patients With Inflammatory Bowel Disease

NCT ID: NCT05599867

Last Updated: 2022-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

quality of life

to assess quality among patients with patients with IBD

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmed Mohammed Abu Elfatth

Lecturer of Tropical Medicine and Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ahmed M Abu-Elfatth

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ahmed

Al Minyā, Alminya, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ahmed M Abu-Elfatth

Role: CONTACT

Phone: +18677791

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29050646 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Amany123

Identifier Type: -

Identifier Source: org_study_id