IBS Skin Patch Test Matallergistudie
En randomisert, dobbeltblind, placebokontrollert, multisenterstudie av patchtest-veiledet type 4 matallergen diettunngåelse for irritabel tarmsyndrom
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Michael B Stierstorfer, MD
- Telefonnummer: 215-699-1929
- E-post: mbstierstorfer@gmail.com
Studer Kontakt Backup
- Navn: Sally Iles, BSN, MBA
- Telefonnummer: 617-922-1130
- E-post: sallyiles3@gmail.com
Studiesteder
-
-
Pennsylvania
-
North Wales, Pennsylvania, Forente stater, 19454
- Rekruttering
- North Wales Dermatology, PLLC
-
Ta kontakt med:
- Michael B Stierstorfer, MD
- Telefonnummer: 215-699-1929
- E-post: mbstierstorfer@gmail.com
-
Ta kontakt med:
- Sally Iles, BSN, MBA
- Telefonnummer: 617-922-1130
- E-post: SallyIles3@gmail.com
-
Hovedetterforsker:
- Michael B Stierstorfer, MD
-
Philadelphia, Pennsylvania, Forente stater, 19104
- Rekruttering
- University of Pennsylvania Dermatology
-
Ta kontakt med:
- Anna Kersh, MD, PhD
- Telefonnummer: 215-699-1929
- E-post: admin@ibsfoodstudy.com
-
Ta kontakt med:
- Sally Iles, BA, MBA
- Telefonnummer: 617-922-1130
- E-post: admin@ibsfoodstudy.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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:
- Under age 18 years
- Pregnant
- Severe rash
- 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)
- 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
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 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 |
Food patch test-directed avoidance diet for 16 weeks where participant avoids avoid eating the food(s) to which they are allergic |
|
Sham-komparator: Sham avoidance diet
Avoidance diet for 16 weeks of randomly selected foods to which the patch testing did not show an allergy |
Avoidance diet for 16 weeks of randomly selected foods to which the patch testing did not show an allergy |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Post-Avoidance Diet Relative IBS Symptom Global Assessment
Tidsramme: Questionnaire to be completed promptly after completion of 16 week avoidance diet.
|
Participant global assessment of IBS symptoms compared to the three months prior to entering study, assessed by a post-avoidance diet questionnaire. The assessment is a 7 point Likert scale with 1=substantially improved; 2=moderately improved; 3=slightly improved; 4=no change; 5=slightly worse; 6=moderately worse; 7=substantially worse |
Questionnaire to be completed promptly after completion of 16 week avoidance diet.
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Michael B Stierstorfer, MD, North Wales Dermatology, PLLC
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Shin GH, Smith MS, Toro B, et al. Utility of food patch testing in the evaluation and management of irritable bowel syndrome. Skin. 2018;2:1-15.
- Stierstorfer MB, Toro B. Patch Test-Directed Dietary Avoidance in the Management of Irritable Bowel Syndrome. Cutis. 2021 Aug;108(2):91-95. doi: 10.12788/cutis.0321.
- Stierstorfer MB, Sha CT, Sasson M. Food patch testing for irritable bowel syndrome. J Am Acad Dermatol. 2013 Mar;68(3):377-84. doi: 10.1016/j.jaad.2012.09.010. Epub 2012 Oct 24.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1003A
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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