Biological Therapy in Patients With Inflammatory Bowel Disease

October 26, 2022 updated by: Ahmed Mohammed Abu Elfatth, Assiut University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Alminya
      • Al Minyā, Alminya, Egypt, 71515
        • Ahmed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Diagnosis of IBD will be based on combination between clinical, laboratory, radiological, endoscopic and/or histopathological data Indications of biological therapy are based on the current diagnostic and treatment recommendations of Epidemiological Committee of European Crohn's and Colitis Organization (ECCO). In most countries, moderate to severe luminal CD, or perianal or fistulising CD, or moderate to severe UC patients with immunosuppressant or corticosteroid refractory disease, or those with intolerance or contraindication to conventional therapies are eligible to be treated with biological therapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life in patients with IBD after biological therapy
Time Frame: one year
we use The SF-36 form
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Ahmed M Abu-Elfatth, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2022

Primary Completion (ANTICIPATED)

November 30, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

October 26, 2022

First Submitted That Met QC Criteria

October 26, 2022

First Posted (ACTUAL)

October 31, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 31, 2022

Last Update Submitted That Met QC Criteria

October 26, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Amany123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

with special request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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