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?

This trial aims to explore whether certain foods or additives might trigger symptoms in people with irritable bowel syndrome (IBS). Participants will undergo a simple skin patch test to check for food allergies. This test involves no needles and requires three short visits. After testing, participants will follow one of two diets: either avoiding foods they are allergic to or avoiding random foods, without knowing which diet they are on. People with IBS who find their symptoms aren't well-controlled might be a good fit for this trial.

As an unphased study, this trial offers a unique opportunity to contribute to understanding IBS triggers and potentially improve personal symptom management.

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 prior data suggests that this skin patch test is safe for participants with IBS?

Research shows that skin patch tests are generally safe and easy to handle. These tests involve placing patches on the skin with small amounts of different substances, like food extracts, to check for allergic reactions. In this study for people with irritable bowel syndrome (IBS), the patches test 80 different foods and additives.

The process is safe and non-invasive, using no needles. Participants might notice mild reactions, like small red marks where the patches were placed. This is normal and helps identify allergies. No reports of serious side effects have emerged from this type of testing. The study is labeled as "Not Applicable," indicating it evaluates the method rather than testing a new drug or device. This suggests a low risk of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Skin Patch Test for Irritable Bowel Syndrome (IBS) because it offers a novel approach to identifying and managing food sensitivities that might contribute to IBS symptoms. Unlike current treatments, which typically involve dietary changes, medications, and probiotics, this method uses a skin patch to pinpoint specific food allergies, potentially allowing for a more targeted dietary avoidance plan. This personalized approach could lead to more effective symptom management for IBS patients by addressing individual triggers rather than applying a one-size-fits-all solution.

What evidence suggests that this trial's treatments could be effective for IBS?

Research has shown that people with irritable bowel syndrome (IBS) often test positive for food allergies more frequently than those without IBS. In this study, a skin patch test checks for reactions to 80 different foods and additives. A red mark may indicate an allergy to that food. Participants in this trial will be divided into different treatment arms. One group will follow a true avoidance diet, avoiding foods identified as allergens by the patch test. Another group will follow a sham avoidance diet, avoiding foods not indicated as allergens by the patch test. Initial findings suggest that avoiding trigger foods might help some people with IBS manage their symptoms better. ^{1 2 3 4 6}

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 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]

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 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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06288672?term=Short%20Bowel%20Syndrome&aggFilters=status:rec&limit=100&rank=32

NCT06288672 | IBS Skin Patch Test Food Allergy Study 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 ...

2. trials.foodallergy.org trials.foodallergy.org/trials/NCT06288672

IBS Skin Patch Test Food Allergy Study - Clinical Trial Finder 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.

3. trial.medpath.com trial.medpath.com/clinical-trial/54fabe5cb5224112/nct06288672-randomized-double-blind-placebo-controlled-food-allergen-dietary-avoidance-irritable

IBS Skin Patch Test Food Allergy Study | MedPath 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4088074/

Food intolerance and skin prick test in treated ... CONCLUSION: Positive food SPT is higher in IBS patients than in controls. Keywords: Irritable bowel syndrome, Skin prick test, Food allergy. INTRODUCTION.

5. withpower.com withpower.com/trial/phase-irritable-bowel-syndrome-7-2023-ced43

Skin Patch Test for Irritable Bowel Syndrome This N/A medical study run by IBS-80, LLC is evaluating whether IBS Skin Patch Test Food Allergy Study will have tolerable side effects & efficacy for ...

6. app.trialscreen.org app.trialscreen.org/trials/ibs-skin-patch-test-food-allergy-trial-nct06288672

IBS Skin Patch Test Food Allergy Study Participants may experience relief from IBS symptoms if they are placed on the 'true' avoidance diet and successfully avoid foods they are allergic to. The ...