Clinical trial NCT06288672: IBS Skin Patch Test Food Allergy Study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Patch Test-Guided Type 4 Food Allergen Dietary Avoidance for Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: irritable bowel syndrome
IBS
FODMAP
low FODMAP
IBS diet
IBS food allergy
IBS solution
IBS treatment
IBS foods
low FODMAP diet
IBS evaluation
irritable bowel syndrome treatment
irritable bowel syndrome management
IBS cause
irritable bowel syndrome pathogenesis
irritable bowel syndrome evaluation
IBS pathogenesis
Lead sponsor: IBS-80, LLC
Sponsor class: INDUSTRY
First posted: 2024-03-01
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Irritable bowel syndrome diagnosed by a primary care provider, gastroenterologist or allergist; or meeting the Rome IV IBS diagnostic criteria by history and having suboptimally or poorly controlled IBS symptoms.

Exclusion Criteria:

1. Under age 18 years
2. Pregnant
3. Severe rash
4. Receiving any cortisone-containing or any of the following immunosuppressive medications within two weeks prior to patch testing or plan to do so any time during the study: cyclosporine, mycophenylate mofetil, azathioprine, tacrolimus or others within these classes of medications)
5. Incapable of completing all parts of the 18-week screening period and study, including following the dietary instructions and completing all text or email questionnaires
6. Exposure of back to the sun in the 2 weeks prior to patch testing Unable or unwilling to discontinue the low FODMAP diet, if relevant, starting 1 week prior to the study and for the study duration

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 \&amp;gt;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

Primary outcomes:
measure: Post-Avoidance Diet Relative IBS Symptom Global Assessment
timeFrame: Questionnaire to be completed promptly after completion of 16 week avoidance diet.
Secondary outcomes:
Other outcomes:
Locations:
city: Marlborough
country: United States
facility: Adult and Pediatric Dermatology
state: Massachusetts
city: Westford
country: United States
facility: Adult and Pediatric Dermatology
state: Massachusetts
city: New York
country: United States
facility: Allergy & Asthma Care of New York
state: New York
city: New York
country: United States
facility: Modern Dermatology NYC
state: New York
city: North Wales
country: United States
facility: North Wales Dermatology, PLLC
state: Pennsylvania
city: Barboursville
country: United States
facility: Shepherd Allergy
state: West Virginia
Study officials:
affiliation: North Wales Dermatology, PLLC
name: Michael B Stierstorfer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.