protocolSection identificationModule nctId: NCT06288672, orgStudyIdInfo id: 1002, briefTitle: IBS Skin Patch Test Food Allergy Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-15, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: IBS-80, LLC, class: INDUSTRY, descriptionModule 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 \&#34;true\&#34; avoidance diet) or food(s) to which the testing did not show an allergy (this is called the \&#34;sham\&#34; 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., conditionsModule conditions: Irritable Bowel Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo 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, maskingInfo 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, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: True avoidance diet, interventions name: Sham avoidance diet, outcomesModule primaryOutcomes measure: Post-Avoidance Diet Relative IBS Symptom Global Assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Adult and Pediatric Dermatology, status: RECRUITING, city: Marlborough, state: Massachusetts, zip: 01752, country: United States, contacts name: Christy Williams, MD, role: CONTACT, phone: 508-460-9613, email: cwilliams@apderm.com, contacts name: Sally Iles, BSN, MBA, role: CONTACT, phone: 617-922-1130, email: SallyIles3@gmail.com, contacts name: Christy Williams, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.34593, lon: -71.55229, locations facility: Adult and Pediatric Dermatology, status: RECRUITING, city: Westford, state: Massachusetts, zip: 01886, country: United States, contacts name: Christy Williams, MD, role: CONTACT, phone: 508-460-9613, email: cwilliams@apderm.com, contacts name: Sally Iles, BSN, MBA, role: CONTACT, phone: 617-922-1130, email: SallyIles3@gmail.com, contacts name: Christy Williams, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.57926, lon: -71.43784, locations facility: Allergy & Asthma Care of New York, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10016, country: United States, contacts name: Clifford Bassett, MD, role: CONTACT, phone: 212-260-6078, email: cliffbassett1@gmail.com, contacts name: Sally Iles, BSN, MBA, role: CONTACT, phone: 617-922-1130, email: SallyIles3@gmail.com, contacts name: Clifford Bassett, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Modern Dermatology NYC, status: RECRUITING, city: New York, state: New York, zip: 10016, country: United States, contacts name: Kathryn Frew, MD, role: CONTACT, phone: 929-533-1797, email: kathrynfrew37@gmail.com, contacts name: Sally Iles, BSN, MBA, role: CONTACT, phone: 617-922-1130, email: SallyIles3@gmail.com, contacts name: Kathryn Frew, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: North Wales Dermatology, PLLC, status: RECRUITING, city: North Wales, state: Pennsylvania, zip: 19454, country: United States, contacts name: Michael B Stierstorfer, MD, role: CONTACT, phone: 215-699-1929, email: mbstierstorfer@gmail.com, contacts name: Sally Iles, BSN, MBA, role: CONTACT, phone: 617-922-1130, email: SallyIles3@gmail.com, contacts name: Michael B Stierstorfer, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.21094, lon: -75.27823, locations facility: Shepherd Allergy, status: RECRUITING, city: Barboursville, state: West Virginia, zip: 25504, country: United States, contacts name: Meagan Shepherd, MD, role: CONTACT, phone: 304-733-3333, email: allergy@shepherdallergy.com, contacts name: Sally Iles, BSN, MBA, role: CONTACT, phone: 617-922-1130, email: SallyIles3@gmail.com, contacts name: Meagan Shepherd, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.40953, lon: -82.29459, hasResults: False