Skin Patch Test for Irritable Bowel Syndrome

Recruiting at 5 trial locations

Overseen By Sally Iles, BSN, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: IBS-80, LLC

Must not be taking: Cortisone, Immunosuppressants, Opiates, others

Disqualifiers: Pregnancy, Severe rash, Gastrointestinal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

250 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{1 2 4 6 7}

Who Is on the Research Team?

Michael B Stierstorfer, MD

Principal Investigator

North Wales Dermatology, PLLC

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: True avoidance diet Active Control 1 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 diet Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

IBS-80, LLC

Lead Sponsor

Trials

1

Recruited

250+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 87 participants, those with diarrhea-predominant IBS (D-IBS) showed a significantly higher reactivity to food allergens (26.3% positive responses) compared to constipation-predominant IBS (C-IBS) and healthy controls, suggesting a potential alteration in intestinal function.

The overall response rates to skin prick tests for food and inhalant allergens were not significantly different among the three groups, indicating that while D-IBS patients may react more to food allergens, the differences in reactivity are not pronounced across all IBS subtypes and healthy individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discrepancies between the responses to skin prick test to food and respiratory antigens in two subtypes of patients with irritable bowel syndrome. Soares, RL., Figueiredo, HN., Santos, JM., et al.[2021]

IBS patients showed significantly higher levels of IgG4 antibodies to certain foods like wheat, beef, pork, and lamb compared to healthy controls, suggesting a potential link between these antibodies and food hypersensitivity in IBS.

No significant differences in IgE levels were found between IBS patients and controls, and elevated IgG4 levels did not correlate with IBS symptoms, indicating that while IgG4 may play a role, it does not directly explain the symptoms experienced by these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food-specific serum IgG4 and IgE titers to common food antigens in irritable bowel syndrome. Zar, S., Benson, MJ., Kumar, D.[2022]

In a study of 10 patients with irritable bowel syndrome (IBS), food hypersensitivity was assessed through skin testing and IgG serum antibodies, but none of the patients experienced worsening symptoms after food challenges.

The results suggest that positive skin tests and elevated IgG antibodies are not reliable indicators of food hypersensitivity in IBS, indicating that food hypersensitivity may not contribute to IBS symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The irritable bowel syndrome and food hypersensitivity. Zwetchkenbaum, J., Burakoff, R.[2004]

There is a potential link between Irritable Bowel Syndrome (IBS) and allergic disorders, with over 50% of diarrhea-type IBS patients having a history of food allergies.

Current research is inconclusive about the role of diet in worsening IBS symptoms, indicating that more studies are necessary to clarify the relationship between IBS and food allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of allergy in irritable bowel syndrome]. Shiotani, A.[2018]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Patch Test-Directed Dietary Avoidance in the Management of Irritable Bowel Syndrome. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Food intolerance and skin prick test in treated and untreated irritable bowel syndrome. [2021]

3. Brazil pubmed.ncbi.nlm.nih.gov

Correlation between symptoms of the irritable bowel syndrome and the response to the food extract skin prick test. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Discrepancies between the responses to skin prick test to food and respiratory antigens in two subtypes of patients with irritable bowel syndrome. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Food-specific serum IgG4 and IgE titers to common food antigens in irritable bowel syndrome. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The irritable bowel syndrome and food hypersensitivity. [2004]

7. Japan pubmed.ncbi.nlm.nih.gov

[Role of allergy in irritable bowel syndrome]. [2018]