Inflammatory Bowel DiseasesNCT03885479
Impact of Different Dietary IgGs on the Pathogenesis of IBD
An observational study of Inflammatory Bowel Diseases and Food Intolerance, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Food Intolerance
- What is being tested?
- ELISA for the semi-quantitative analysis of serum food-specific IgGs against food-derived antigens
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Case group: IBD patients Control group: Normal individuals
Who may be able to join
- Inflammatory bowel disease patients (Ulcerative colitis and Crohn's disease)
- Patients aged ≥ 18 years old
Who cannot join
- Patients who started TNF-α inhibitor (Infliximab)
Trial locations and contacts
No sites are listed yet.
Hebatallah Mohammed Abdelwahab Mohammed Abdelrahman, Doctor contact
Lobna Abdelwahed Ahmed, Professor contact
About this study
Official title: Impact of Different Dietary IgGs on the Pathogenesis of Inflammatory Bowel Disease
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
Read the 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.
- Conditions
- Inflammatory Bowel Diseases, Food Intolerance
- Being tested
- ELISA for the semi-quantitative analysis of serum food-specific IgGs against food-derived antigens
- Keywords
- Inflammatory bowel disease, Food specific IgGs
- Medical subject headings
- Inflammatory Bowel Diseases, Food Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISA for the semi-quantitative analysis of serum food-specific IgGs against food-derived antigensDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Diagnostic Test: ELISA for the semi-quantitative analysis of serum food-specific IgGs against food-derived antigens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hebatallah Mohammed Abdelwahab Mohammed Abdelrahman, Assiut University
- Investigators
- Mohamed Elyamany, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885479
- Sponsor's protocol ID
- IBDIgG
- Status last verified
- Mar 2019
- First submitted
- 18 Mar 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 16151544Dahlhamer 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.
PubMed 27787492Nguyen 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.
PubMed 24074875Ananthakrishnan 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.
PubMed 23912083Mekkel 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.
PubMed 17918636Bentz 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.
PubMed 20130407Koretz 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.
PubMed 17311654
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Dietary IgGs on the Pathogenesis of Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03885479
- Acronym / sponsor ID
- IBDIgG
- Conditions
- Inflammatory Bowel Diseases, Food Intolerance
- Keywords
- Inflammatory bowel disease, Food specific IgGs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD patients | – | Diagnostic Test: ELISA for the semi-quantitative analysis of serum food-specific IgGs against food-derived antigens1. 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 |
| Controls | – | Diagnostic Test: ELISA for the semi-quantitative analysis of serum food-specific IgGs against food-derived antigensAn 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Case group: IBD patients Control group: Normal individuals
Key inclusion criteria (2 listed)
- Inflammatory bowel disease patients (Ulcerative colitis and Crohn's disease)
- Patients aged ≥ 18 years old
Key exclusion criteria (1 listed)
- Patients who started TNF-α inhibitor (Infliximab)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELISA for the semi-quantitative analysis of serum food-specific IgGs against food-derived antigensAn 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 | Controls, IBD patients |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Background: PubMed 16151544Silverberg 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.
- Background: PubMed 27787492Dahlhamer 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.
- Background: PubMed 24074875Nguyen 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.
- Background: PubMed 23912083Ananthakrishnan 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.
- Background: PubMed 17918636Mekkel 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.
- Background: PubMed 20130407Bentz 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.
- Background: PubMed 17311654Koretz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hebatallah Mohammed Abdelwahab Mohammed Abdelrahman, Doctor contact
Lobna Abdelwahed Ahmed, Professor contact
Mohamed Elyamany, Professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Food Intolerance, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hebatallah Mohammed Abdelwahab Mohammed Abdelrahman, Doctor (00201068231787, hebatallah.m.abdelrahman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of serum food specific IgGs in patients with IBD (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03885479, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.