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Impact of Different Dietary IgGs on the Pathogenesis of IBD

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ClinicalTrials.gov Identifier: NCT03885479
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Hebatallah Mohammed Abdelwahab Mohammed Abdelrahman, Assiut University

Brief Summary:
Identify the association between certain food IgGs (Wheat, rice, broad beans, cow milk, eggs, chicken and beef) and the immunological response in patients with IBD

Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Food Intolerance Diagnostic Test: ELISA for the semi-quantitative analysis of serum food-specific IgGs against food-derived antigens

Detailed Description:

Inflammatory bowel disease (IBD) is comprised of two major disorders: ulcerative colitis and Crohn disease. Ulcerative colitis and Crohn disease have distinct pathologic and clinical characteristics but their pathogenesis remains poorly understood.

In 2015, an estimated 1.3% of US adults (3 million) reported being diagnosed with IBD (either Crohn's disease or ulcerative colitis). This was a large increase from 1999 (0.9% or 2 million adults).The incidence and prevalence of Crohn disease and ulcerative colitis (UC) appear to be lower in Asia and the Middle East , however, in some newly industrialized countries in Africa, Asia, and South America, the incidence of IBD has been rising.

Ulcerative colitis is a chronic inflammatory condition characterized by relapsing and remitting episodes of inflammation limited to the mucosal layer of the colon. It almost invariably involves the rectum and typically extends in a proximal and continuous fashion to involve other portions of the colon.

Crohn disease is characterized by transmural inflammation and by skip lesions. The transmural inflammatory nature of Crohn disease may lead to fibrosis and strictures, and to obstructive clinical presentations that are not typically seen in ulcerative colitis. The transmural inflammation more commonly results in sinus tracts, giving rise to microperforations and fistulae.

Food antigens are thought to trigger an immunologic response resulting in the development of IBD. However, specific pathogenic antigens have not been identified. While studies attempting to associate specific diets with the development of IBD have had inconsistent results, the data suggest that a "Western" style diet (processed, fried, and sugary foods) is associated with an increased risk of developing Crohn disease, and possibly ulcerative colitis.

To date, studies concerning food intolerance in IBD have largely focused on classic food allergies based on IgE mediated antibody responses. The levels of total or food-specific IgEs have been observed to be increased in the sera of IBD patients, and IgE-mediated food allergies are more frequent in IBD patients than in those without IBDs. Nevertheless, reactions mediated by food specific IgGs, featuring a more delayed response following exposure to a particular antigen, are also expected to contribute to adverse reactions in IBD, and food-specific IgGs help physicians identify the candidate food for elimination in IBD patients. Furthermore, IgG-mediated adverse reactions have also been reported to be involved in some cases of food hypersensitivity.

Elimination diet can help in the remission of the disease. An elimination diet involves removing a food from the diet for a period of time and seeing whether symptoms resolve during that time. In patients receiving enteral nutrition, it involves introducing one new food at a time to identify foods that precipitate IBD symptoms. Many patients can identify foods that they believe may precipitate or worsen their disease and it is reasonable for them to avoid such foods. Using an elimination diet to identify at-risk foods may decrease the possibility of a "flare" of IBD.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Impact of Different Dietary IgGs on the Pathogenesis of Inflammatory Bowel Disease
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

Group/Cohort Intervention/treatment
IBD patients
  1. Full history taking and examination
  2. Colonoscopy, biopsy and histopathology to determine the extent of the lesion
  3. An enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative analysis of serum food-specific IgGs against 7 food-derived antigens (Wheat, rice, beans, cow milk, eggs, chicken and beef)
  4. Patients will be categorized into 3 groups (UC patients, Crohn disease patients and controls)
  5. All of the following factors will be taken into consideration; type and duration of the treatment, age of diagnosis, BMI, smoking status and activity of the disease at the time of the study
Diagnostic Test: ELISA for the semi-quantitative analysis of serum food-specific IgGs against food-derived antigens
An enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative analysis of serum food-specific IgGs against 7 food-derived antigens (Wheat, rice, beans, cow milk, eggs, chicken and beef)

Controls
An enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative analysis of serum food-specific IgGs against 7 food-derived antigens (Wheat, rice, beans, cow milk, eggs, chicken and beef)
Diagnostic Test: ELISA for the semi-quantitative analysis of serum food-specific IgGs against food-derived antigens
An enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative analysis of serum food-specific IgGs against 7 food-derived antigens (Wheat, rice, beans, cow milk, eggs, chicken and beef)




Primary Outcome Measures :
  1. Level of serum food specific IgGs in patients with IBD [ Time Frame: baseline ]
    Level of serum food specific IgGs in patients with Inflammatory bowel diseasea against 7 food-derived antigens (Wheat, rice, beans, cow milk, eggs, chicken and beef)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Case group: IBD patients Control group: Normal individuals
Criteria

Inclusion Criteria:

  • Inflammatory bowel disease patients (Ulcerative colitis and Crohn's disease)
  • Patients aged ≥ 18 years old

Exclusion Criteria:

• Patients who started TNF-α inhibitor (Infliximab)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885479


Contacts
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Contact: Hebatallah Mohammed Abdelwahab Mohammed Abdelrahman, Doctor 00201068231787 hebatallah.m.abdelrahman@gmail.com
Contact: Lobna Abdelwahed Ahmed, Professor 00201093337630

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Mohamed Elyamany, Professor Assiut University
Publications:

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Responsible Party: Hebatallah Mohammed Abdelwahab Mohammed Abdelrahman, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03885479    
Other Study ID Numbers: IBDIgG
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hebatallah Mohammed Abdelwahab Mohammed Abdelrahman, Assiut University:
Inflammatory bowel disease
Food specific IgGs
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Food Intolerance
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Signs and Symptoms, Digestive