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IBS Skin Patch Test Food Allergy Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 >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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06288672
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

IBS-80, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Michael B Stierstorfer, MD
Principal Investigator Affiliation North Wales Dermatology, PLLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Irritable Bowel Syndrome
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: 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

Sham Comparator: Sham avoidance diet

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

Interventions

Other: - 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

Other: - Sham avoidance diet

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Adult and Pediatric Dermatology, Marlborough, Massachusetts

Status

Recruiting

Address

Adult and Pediatric Dermatology

Marlborough, Massachusetts, 01752

Site Contact

Christy Williams, MD

[email protected]

508-460-9613

Adult and Pediatric Dermatology, Westford, Massachusetts

Status

Recruiting

Address

Adult and Pediatric Dermatology

Westford, Massachusetts, 01886

Site Contact

Christy Williams, MD

[email protected]

508-460-9613

Allergy & Asthma Care of New York, New York, New York

Status

Not yet recruiting

Address

Allergy & Asthma Care of New York

New York, New York, 10016

Site Contact

Clifford Bassett, MD

[email protected]

212-260-6078

Modern Dermatology NYC, New York, New York

Status

Recruiting

Address

Modern Dermatology NYC

New York, New York, 10016

Site Contact

Kathryn Frew, MD

[email protected]

929-533-1797

North Wales Dermatology, PLLC, North Wales, Pennsylvania

Status

Recruiting

Address

North Wales Dermatology, PLLC

North Wales, Pennsylvania, 19454

Site Contact

Michael B Stierstorfer, MD

[email protected]

215-699-1929

Shepherd Allergy, Barboursville, West Virginia

Status

Recruiting

Address

Shepherd Allergy

Barboursville, West Virginia, 25504

Site Contact

Meagan Shepherd, MD

[email protected]

304-733-3333

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