Impact of Different Dietary IgGs on the Pathogenesis of IBD

NCT03885479 | Unknown DMC

• 1 other identifier: IBDIgG
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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

Conditions

Inflammatory Bowel Diseases; Food Intolerance

Keywords

Inflammatory bowel disease; Food specific IgGs

Outcome Measures

Primary Outcomes (1)

• Level of serum food specific IgGs in patients with IBD

  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)

  baseline

Study Arms (2)

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

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

Interventions

ELISA for the semi-quantitative analysis of serum food-specific IgGs against food-derived antigens DIAGNOSTIC_TEST

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; IBD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Case group: IBD patients Control group: Normal individuals

You may qualify if:

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

You may not qualify if:

• Patients who started TNF-α inhibitor (Infliximab)

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• Silverberg MS, Satsangi J, Ahmad T, Arnott ID, Bernstein CN, Brant SR, Caprilli R, Colombel JF, Gasche C, Geboes K, Jewell DP, Karban A, Loftus EV Jr, Pena AS, Riddell RH, Sachar DB, Schreiber S, Steinhart AH, Targan SR, Vermeire S, Warren BF. Toward an integrated clinical, molecular and serological classification of inflammatory bowel disease: report of a Working Party of the 2005 Montreal World Congress of Gastroenterology. Can J Gastroenterol. 2005 Sep;19 Suppl A:5A-36A. doi: 10.1155/2005/269076.

  PMID: 16151544 BACKGROUND

• Dahlhamer JM, Zammitti EP, Ward BW, Wheaton AG, Croft JB. Prevalence of Inflammatory Bowel Disease Among Adults Aged >/=18 Years - United States, 2015. MMWR Morb Mortal Wkly Rep. 2016 Oct 28;65(42):1166-1169. doi: 10.15585/mmwr.mm6542a3.

  PMID: 27787492 BACKGROUND

• Nguyen GC, Chong CA, Chong RY. National estimates of the burden of inflammatory bowel disease among racial and ethnic groups in the United States. J Crohns Colitis. 2014 Apr;8(4):288-95. doi: 10.1016/j.crohns.2013.09.001. Epub 2013 Sep 24.

  PMID: 24074875 BACKGROUND

• Ananthakrishnan AN, Khalili H, Konijeti GG, Higuchi LM, de Silva P, Korzenik JR, Fuchs CS, Willett WC, Richter JM, Chan AT. A prospective study of long-term intake of dietary fiber and risk of Crohn's disease and ulcerative colitis. Gastroenterology. 2013 Nov;145(5):970-7. doi: 10.1053/j.gastro.2013.07.050. Epub 2013 Aug 2.

  PMID: 23912083 BACKGROUND

• Mekkel G, Barta Z, Ress Z, Gyimesi E, Sipka S, Zeher M. [Increased IgE-type antibody response to food allergens in irritable bowel syndrome and inflammatory bowel diseases]. Orv Hetil. 2005 Apr 24;146(17):797-802. Hungarian.

  PMID: 17918636 BACKGROUND

• Bentz S, Hausmann M, Piberger H, Kellermeier S, Paul S, Held L, Falk W, Obermeier F, Fried M, Scholmerich J, Rogler G. Clinical relevance of IgG antibodies against food antigens in Crohn's disease: a double-blind cross-over diet intervention study. Digestion. 2010;81(4):252-64. doi: 10.1159/000264649. Epub 2010 Jan 30.

  PMID: 20130407 BACKGROUND

• Koretz RL, Avenell A, Lipman TO, Braunschweig CL, Milne AC. Does enteral nutrition affect clinical outcome? A systematic review of the randomized trials. Am J Gastroenterol. 2007 Feb;102(2):412-29; quiz 468. doi: 10.1111/j.1572-0241.2006.01024.x.

  PMID: 17311654 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Food Intolerance

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamed Elyamany, Professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Hebatallah Mohammed Abdelwahab Mohammed Abdelrahman, Doctor

CONTACT

00201068231787; hebatallah.m.abdelrahman@gmail.com

Lobna Abdelwahed Ahmed, Professor

CONTACT

00201093337630

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 21, 2019
• Study Start: April 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: March 31, 2020
• Last Updated: March 21, 2019

Record last verified: 2019-03