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Participants with IBS are skin patch tested (no needles) to 80 different foods and food additives, compounded for patch testing, in search of food allergies. The testing requires 3 office visits within a 4 or 5 day period. The patches are taped to the back at Visit #. At Visit #2 48 hours later, the patches are removed from the skin and the outside border of each patch is marked with a felt tip marker. At Visit #3 (final visit) 1 or 2 days later, the patch test reading is performed by the doctor-investigator. An allergy is identified as a small red mark where the food was in contact with the skin for 48 hours. Those participants found to have food allergies are then placed on an avoidance diet (no calorie restriction) for 16 weeks where they either avoid eating the food(s) to which they are allergic (the "true" avoidance diet) or food(s) to which the testing did not show an allergy (this is called the "sham" avoidance diet). There is a 50/50 chance of going on either avoidance diet. The avoidance diet is assigned in such a way that neither the participant or the doctor-investigator knows which diet is being followed. After the 16 weeks, the participants answers a brief online questionnaire that asks about the IBS symptoms while following the avoidance diet. After the 16 week avoidance diet and final questionnaire are completed, those participants who were on the sham diet will be told of their true food allergies which they may try avoiding on their own.
See above. When all 250 study participants have finished all parts of the study, the results will be made known to the doctor-investigators for data analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| True avoidance diet | Active Comparator | Food patch test-directed avoidance diet for 16 weeks where participant avoids avoid eating the food(s) to which they are allergic |
|
| Sham avoidance diet | Sham Comparator | Avoidance diet for 16 weeks of randomly selected foods to which the patch testing did not show an allergy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| True avoidance diet | Other | Food patch test-directed avoidance diet for 16 weeks where participant avoids avoid eating the food(s) to which they are allergic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-Avoidance Diet Relative IBS Symptom Global Assessment | Participant global assessment of IBS symptoms compared to the three months prior to entering study, assessed by a post-avoidance diet questionnaire. The assessment is a 7 point Likert scale with 1=substantially improved; 2=moderately improved; 3=slightly improved; 4=no change; 5=slightly worse; 6=moderately worse; 7=substantially worse | Questionnaire to be completed promptly after completion of 16 week avoidance diet. |
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Inclusion Criteria:
Exclusion Criteria:
8) Refusal to shave back hair, if relevant 9) Receiving pharmacologic therapy for IBS that has been started or changed within 30 days of study enrollment 10) Non-English speaking 11) Unable to provide written informed consent 12) Have a history of gastrointestinal disease including celiac disease, cirrhosis, gastrointestinal malignancy, inflammatory bowel disease, or diverticulitis, active within the prior 2 years. 13) Have a history of gastrointestinal surgery (except appendectomy and cholecystectomy or gallbladder removal >6 months ago) 14) Have poorly controlled psychiatric disease such as severe depression (with or without suicidal ideation), severe anxiety, schizophrenia, dementia 15) Have excessive alcohol intake (more than 1 drink per day for females and 2 drinks per day for males) 16) Use illicit substances 17) Use high-dose opiates 18) Severe allergy to adhesive tape
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael B Stierstorfer, MD | Contact | 215-699-1929 | mbstierstorfer@gmail.com | |
| Sally Iles, BSN, MBA | Contact | 617-922-1130 | sallyiles3@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael B Stierstorfer, MD | North Wales Dermatology, PLLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Wales Dermatology, PLLC | Recruiting | North Wales | Pennsylvania | 19454 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Shin GH, Smith MS, Toro B, et al. Utility of food patch testing in the evaluation and management of irritable bowel syndrome. Skin. 2018;2:1-15. | ||
| 34735319 | Result | Stierstorfer MB, Toro B. Patch Test-Directed Dietary Avoidance in the Management of Irritable Bowel Syndrome. Cutis. 2021 Aug;108(2):91-95. doi: 10.12788/cutis.0321. | |
| 23102771 |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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Participants with IBS are patch tested to 80 type 4 food allergens. Those with questionable or positive patch test reactions are randomized to follow a patch test-directed avoidance diet or a sham diet (avoidance of foods to which the patch tests showed no reaction) for 16 weeks. Upon conclusion of the avoidance diet, participants complete a brief questionnaire to assess their response to the avoidance diet.
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The true or sham avoidance diet for each participant is randomly assigned by the study administrator. Assignments will not be made available to participants until after their study completion or to investigators until all 250 participants have completed the study and the results have been analyzed.
| Sham avoidance diet | Other | Avoidance diet for 16 weeks of randomly selected foods to which the patch testing did not show an allergy |
|
| Shepherd Allergy | Recruiting | Barboursville | West Virginia | 25504 | United States |
|
| Result |
| Stierstorfer MB, Sha CT, Sasson M. Food patch testing for irritable bowel syndrome. J Am Acad Dermatol. 2013 Mar;68(3):377-84. doi: 10.1016/j.jaad.2012.09.010. Epub 2012 Oct 24. |
| D004066 | Digestive System Diseases |