nctId: NCT06288672 id: 1002 briefTitle: IBS Skin Patch Test Food Allergy Study overallStatus: RECRUITING date: 2023-08-15 date: 2025-12 date: 2025-12 date: 2024-03-01 date: 2024-03-01 name: IBS-80, LLC class: INDUSTRY briefSummary: 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. conditions: Irritable Bowel Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 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. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: 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. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: True avoidance diet name: Sham avoidance diet measure: Post-Avoidance Diet Relative IBS Symptom Global Assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Adult and Pediatric Dermatology status: RECRUITING city: Marlborough state: Massachusetts zip: 01752 country: United States name: Christy Williams, MD role: CONTACT phone: 508-460-9613 email: cwilliams@apderm.com name: Sally Iles, BSN, MBA role: CONTACT phone: 617-922-1130 email: SallyIles3@gmail.com name: Christy Williams, MD role: PRINCIPAL_INVESTIGATOR lat: 42.34593 lon: -71.55229 facility: Adult and Pediatric Dermatology status: RECRUITING city: Westford state: Massachusetts zip: 01886 country: United States name: Christy Williams, MD role: CONTACT phone: 508-460-9613 email: cwilliams@apderm.com name: Sally Iles, BSN, MBA role: CONTACT phone: 617-922-1130 email: SallyIles3@gmail.com name: Christy Williams, MD role: PRINCIPAL_INVESTIGATOR lat: 42.57926 lon: -71.43784 facility: Allergy & Asthma Care of New York status: NOT_YET_RECRUITING city: New York state: New York zip: 10016 country: United States name: Clifford Bassett, MD role: CONTACT phone: 212-260-6078 email: cliffbassett1@gmail.com name: Sally Iles, BSN, MBA role: CONTACT phone: 617-922-1130 email: SallyIles3@gmail.com name: Clifford Bassett, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Modern Dermatology NYC status: RECRUITING city: New York state: New York zip: 10016 country: United States name: Kathryn Frew, MD role: CONTACT phone: 929-533-1797 email: kathrynfrew37@gmail.com name: Sally Iles, BSN, MBA role: CONTACT phone: 617-922-1130 email: SallyIles3@gmail.com name: Kathryn Frew, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: North Wales Dermatology, PLLC status: RECRUITING city: North Wales state: Pennsylvania zip: 19454 country: United States name: Michael B Stierstorfer, MD role: CONTACT phone: 215-699-1929 email: mbstierstorfer@gmail.com name: Sally Iles, BSN, MBA role: CONTACT phone: 617-922-1130 email: SallyIles3@gmail.com name: Michael B Stierstorfer, MD role: PRINCIPAL_INVESTIGATOR lat: 40.21094 lon: -75.27823 facility: Shepherd Allergy status: RECRUITING city: Barboursville state: West Virginia zip: 25504 country: United States name: Meagan Shepherd, MD role: CONTACT phone: 304-733-3333 email: allergy@shepherdallergy.com name: Sally Iles, BSN, MBA role: CONTACT phone: 617-922-1130 email: SallyIles3@gmail.com name: Meagan Shepherd, MD role: PRINCIPAL_INVESTIGATOR lat: 38.40953 lon: -82.29459 hasResults: False