The Diagnostic Predictability of Food Allergy Testing

NCT01791621 | Completed

• 1 other identifier: CCNM1301
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Irritable bowel syndrome (IBS) sufferers often find that specific foods can exacerbate their symptoms; identifying which foods involves a long and arduous process. Different food allergy tests are marketed to IBS sufferers and healthcare practitioners as an easy way to identify these offending foods. Which test method might be best to use? This project compares the results of different food allergy methods versus an elimination/challenge diet to determine which method maybe superior in IBS sufferers.

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

Irritable Bowel Syndrome; Elimination diet; Food allergies

Outcome Measures

Primary Outcomes (1)

• Intra-individual agreement: food elimination challenge versus non-immunoglobulin E (IgE) mediated food allergy test results

  For each participant, a summary and analysis of agreement, using Cohen's kappa, will be undertaken comparing the results of each non-IgE mediated food allergy assessment method and the Elimination/Challenge diet for the 8 food items challenged. Similarly, secondary analysis will compare the degree of agreement between the intensity (high, medium, low and no reaction) on the non-IgE mediated food allergy results and the food reaction numerical scores.

  Weeks 5 through 9 is the challenge phase of the study. Results will be compared between the participants recorded symptoms during this phase to each challenged food item and the results of the non-IgE mediated food allergy test results from Week 1.

Other Outcomes (2)

• Inter-laboratory agreement regarding Non-IgE mediated food allergies

  Week 1: all non-IgE food allergy assessments will be completed. Comparison between the various results of the test will be performed at the completion of the study, once researchers are unblinded to the results

• Benefit of Elimination Diet

  Results will be compared between week 4 and week 1 of the sudy.

Study Arms (1)

Elimination/Challenge Diet

EXPERIMENTAL

Once non-IgE mediated food allergy testing has been administered, study participants will follow food choices according to a pre-specified elimination diet for three weeks (Elimination phase). After the Elimination phase, study participants will introduce one food every three days (Challenge phase)and monitor their symptoms. Eight different foods will be introduced in the Challenge phase of the study.

Other: Elimination/Challenge Diet

Interventions

Elimination/Challenge Diet OTHER

An pre-specified elimination diet contains a list of food items permitted to be consumed by the study participants. These food items, selected to be consumed are whole foods of low allergenicity. The challenge phase of the diet involves introducing 8 different foods at three days intervals. the selected challenge foods will be selected based on a review of the non-IgE mediated food allergy test results by a third-party, not directly associated with the project team.

Elimination/Challenge Diet

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female study participants aged 18-64.
• A diagnosis of Irritable Bowel Syndrome as per ROME III criteria.
• A classification of moderate to severe irritable bowel syndrome as indicated by the Irritable Bowel Severity Scoring System (score \>200).
• Not currently eliminating any foods from their diet.
• Female study participants currently using an acceptable form of birth control who agree to maintain its use throughout the study (e.g. abstinence, oral contraceptives, barrier methods).
• Ability to understand and sign the Informed Consent Form.

You may not qualify if:

• Female study participants who are breastfeeding, pregnant, or are open to becoming pregnant in the next three months.
• Those individuals with celiac disease.
• Study participants currently experiencing nausea, fever, vomiting, bloody diarrhea, or severe abdominal pain.
• Study participants with a previous diagnosis of Crohn's disease or ulcerative colitis by another health care provider.
• Study participants who are immune-compromised (e.g. AIDS, lymphoma, patients undergoing long-term corticosteroid treatment).
• Study participants who have recently (\< 1 month) initiated dietary measures to control IBS symptoms.
• Study participants with a history of major or complicated gastrointestinal surgery.
• Study participants with severe endometriosis.
• Study participants with malignant tumors or study participants undergoing chemotherapy or radiation therapy.
• Study participants with known anaphylaxis reactions to specific consumed food items.

Sponsors & Collaborators

• The Canadian College of Naturopathic Medicine: lead

Study Sites (1)

The Canadian College of Naturopathic Medicine

Toronto, Ontario, M2K 1E2, Canada

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Deborah A Kennedy, ND, PhD

  The Canadian College of Naturopathic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 11, 2013
• First Posted: February 15, 2013
• Study Start: January 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 18, 2013

Record last verified: 2013-07

Locations

CA (1)