250 Participants Needed

Skin Patch Test for Irritable Bowel Syndrome

Recruiting at 5 trial locations
MB
SI
Overseen BySally Iles, BSN, MBA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications like cortisone or immunosuppressive drugs two weeks before and during the study. If you're on a low FODMAP diet, you'll need to stop that one week before and during the study as well.

What data supports the effectiveness of the IBS Skin Patch Test treatment?

Research shows that using a skin patch test to identify food sensitivities can help manage IBS symptoms by guiding dietary changes. Patients who avoided foods identified by the patch test reported improvements in abdominal pain and overall IBS symptoms after more than three months.12345

Is the IBS Skin Patch Test safe for humans?

The available research does not provide specific safety data for the IBS Skin Patch Test, but it does not report any adverse effects from the test itself in the studies conducted.12367

How does the skin patch test treatment for IBS differ from other treatments?

The skin patch test treatment for IBS is unique because it identifies specific food sensitivities that may trigger symptoms, allowing for a personalized avoidance diet. This approach is different from standard IBS treatments, which typically focus on managing symptoms rather than identifying and avoiding specific food triggers.12346

What is the purpose of this trial?

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.

Research Team

MB

Michael B Stierstorfer, MD

Principal Investigator

North Wales Dermatology, PLLC

Eligibility Criteria

This trial is for individuals with Irritable Bowel Syndrome (IBS) who are interested in finding out if food allergies might be contributing to their symptoms. Participants will undergo skin patch testing for various foods and additives, but they must be able to visit the office three times over a few days.

Inclusion Criteria

I have been diagnosed with irritable bowel syndrome that is not well-controlled.

Exclusion Criteria

I have a severe skin rash.
Unable to provide written informed consent
Use illicit substances
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week
3 visits (in-person)

Patch Testing

Participants undergo skin patch testing to 80 different foods and food additives over 3 visits

4-5 days
3 visits (in-person)

Avoidance Diet

Participants follow a 16-week avoidance diet based on patch test results, either true or sham

16 weeks
Online questionnaire at the end

Follow-up

Participants complete a post-avoidance diet questionnaire to assess IBS symptoms

1 week
Online questionnaire

Treatment Details

Interventions

  • IBS Skin Patch Test Food Allergy Study
Trial Overview The study tests whether avoiding certain foods after identifying potential allergies can improve IBS symptoms. Participants follow either a 'true' avoidance diet excluding identified allergens or a 'sham' diet where no allergens are avoided, without knowing which one they're on.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: True avoidance dietActive Control1 Intervention
Food patch test-directed avoidance diet for 16 weeks where participant avoids avoid eating the food(s) to which they are allergic
Group II: Sham avoidance dietPlacebo Group1 Intervention
Avoidance diet for 16 weeks of randomly selected foods to which the patch testing did not show an allergy

Find a Clinic Near You

Who Is Running the Clinical Trial?

IBS-80, LLC

Lead Sponsor

Trials
1
Recruited
250+

Findings from Research

Skin patch testing for delayed-type food hypersensitivities can help identify triggers for irritable bowel syndrome (IBS) symptoms, providing a new method for evaluation and management of IBS.
Patients who followed patch test-directed avoidance diets reported significant improvements in abdominal pain and overall IBS symptoms after more than 3 months, suggesting that addressing food sensitivities may alleviate IBS symptoms.
Patch Test-Directed Dietary Avoidance in the Management of Irritable Bowel Syndrome.Stierstorfer, MB., Toro, B.[2021]
In a study of 105 subjects, including treated and untreated IBS patients, positive skin prick test (SPT) results for allergens were significantly more common in treated IBS patients (38.6%) compared to untreated patients (16.1%) and control subjects (3.3%).
The findings suggest that IBS patients, especially those receiving treatment, have a higher prevalence of positive food allergens, indicating a potential link between IBS symptoms and allergic responses.
Food intolerance and skin prick test in treated and untreated irritable bowel syndrome.Jun, DW., Lee, OY., Yoon, HJ., et al.[2021]
In a study of 43 volunteers, those with irritable bowel syndrome (IBS) showed a significantly higher rate of positive skin reactions to food antigens (19.4%) compared to those with functional dyspepsia (2.3%) and healthy controls (4%), suggesting a potential link between IBS and increased intestinal permeability.
Despite the higher reactivity to food antigens, none of the IBS participants reported specific food intolerances, indicating that while there may be a heightened immune response, it does not necessarily correlate with perceived food intolerance.
Correlation between symptoms of the irritable bowel syndrome and the response to the food extract skin prick test.Soares, RL., Figueiredo, HN., Maneschy, CP., et al.[2019]

References

Patch Test-Directed Dietary Avoidance in the Management of Irritable Bowel Syndrome. [2021]
Food intolerance and skin prick test in treated and untreated irritable bowel syndrome. [2021]
Correlation between symptoms of the irritable bowel syndrome and the response to the food extract skin prick test. [2019]
Discrepancies between the responses to skin prick test to food and respiratory antigens in two subtypes of patients with irritable bowel syndrome. [2021]
Food-specific serum IgG4 and IgE titers to common food antigens in irritable bowel syndrome. [2022]
The irritable bowel syndrome and food hypersensitivity. [2004]
[Role of allergy in irritable bowel syndrome]. [2018]
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