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IBS Skin Patch Test Food Allergy Study
NCT06288672 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- OTHER True avoidance diet
- OTHER Sham avoidance diet
Study Locations (2)
Pennsylvania
- North Wales Dermatology, PLLC — North Wales
West Virginia
- Shepherd Allergy — Barboursville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2023-08-15 |
| Est. Completion | 2026-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06288672
The ClinicalTrials.gov registry entry for NCT06288672 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is IBS-80, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Irritable Bowel Syndrome appearing as the primary indexed condition, and to 2 interventions — of which True avoidance diet is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06288672 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Pennsylvania, West Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06288672 about?
NCT06288672 is a clinical study titled "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. 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...
What is the current status of trial NCT06288672?
This trial is currently recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2023-08-15. Estimated completion is 2026-12.
What conditions does trial NCT06288672 study?
This clinical trial studies the following conditions: Irritable Bowel Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06288672?
The interventions under investigation include: True avoidance diet (OTHER), Sham avoidance diet (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06288672?
This trial is sponsored by IBS-80, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06288672 being conducted?
This trial has 2 study locations across Pennsylvania, West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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