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IBS Skin Patch Test Food Allergy Study

NCT ID: NCT06288672

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-15

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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True avoidance diet

Food patch test-directed avoidance diet for 16 weeks where participant avoids avoid eating the food(s) to which they are allergic

Group Type ACTIVE_COMPARATOR

True avoidance diet

Intervention Type OTHER

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

Avoidance diet for 16 weeks of randomly selected foods to which the patch testing did not show an allergy

Group Type SHAM_COMPARATOR

Sham avoidance diet

Intervention Type OTHER

Avoidance diet for 16 weeks of randomly selected foods to which the patch testing did not show an allergy

Interventions

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True avoidance diet

Food patch test-directed avoidance diet for 16 weeks where participant avoids avoid eating the food(s) to which they are allergic

Intervention Type OTHER

Sham avoidance diet

Avoidance diet for 16 weeks of randomly selected foods to which the patch testing did not show an allergy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Irritable bowel syndrome diagnosed by a primary care provider, gastroenterologist or allergist; or
2. 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 \>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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IBS-80, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael B Stierstorfer, MD

Role: PRINCIPAL_INVESTIGATOR

North Wales Dermatology, PLLC

Locations

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North Wales Dermatology, PLLC

North Wales, Pennsylvania, United States

Site Status RECRUITING

Shepherd Allergy

Barboursville, West Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michael B Stierstorfer, MD

Role: CONTACT

[email protected]
215-699-1929

Sally Iles, BSN, MBA

Role: CONTACT

[email protected]
617-922-1130

Facility Contacts

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Michael B Stierstorfer, MD

Role: primary

[email protected]
215-699-1929

Sally Iles, BSN, MBA

Role: backup

[email protected]
617-922-1130

Meagan Shepherd, MD

Role: primary

[email protected]
304-733-3333

Sally Iles, BSN, MBA

Role: backup

[email protected]
617-922-1130

References

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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.

Reference Type BACKGROUND

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.

Reference Type RESULT
PMID: 34735319 (View on PubMed)

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.

Reference Type RESULT
PMID: 23102771 (View on PubMed)

Other Identifiers

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1003A

Identifier Type: -

Identifier Source: org_study_id