Status:
COMPLETED
The Diagnostic Predictability of Food Allergy Testing
Lead Sponsor:
The Canadian College of Naturopathic Medicine
Conditions:
Irritable Bowel Syndrome (IBS)
Eligibility:
All Genders
18-64 years
Phase:
NA
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 mar...
Detailed Description
A variety of methods are available to assess food items that an individual with IBS may not tolerate well. No study has compared the predictability of each method to the results of an Elimination/Chal...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Female study participants who are breastfeeding, pregnant, or are open to becoming pregnant in the next three months.
- Study participants currently receiving medication for the treatment of IBS symptoms. Study participants currently receiving natural health products for treatment of IBS symptoms will be eligible for inclusion in the study is they agree to undergo a two-week washout period.
- 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.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01791621
Start Date
January 1 2013
End Date
May 1 2013
Last Update
July 18 2013
Active Locations (1)
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1
The Canadian College of Naturopathic Medicine
Toronto, Ontario, Canada, M2K 1E2