IBS 피부 패치 테스트 식품 알레르기 연구
과민성 대장 증후군에 대한 패치 테스트 유도 유형 4 식품 알레르기 유발 물질 식이 회피에 대한 무작위, 이중 맹검, 위약 대조, 다기관 연구
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Michael B Stierstorfer, MD
- 전화번호: 215-699-1929
- 이메일: mbstierstorfer@gmail.com
연구 연락처 백업
- 이름: Sally Iles, BSN, MBA
- 전화번호: 617-922-1130
- 이메일: sallyiles3@gmail.com
연구 장소
-
-
Pennsylvania
-
North Wales, Pennsylvania, 미국, 19454
- 모병
- North Wales Dermatology, PLLC
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연락하다:
- Michael B Stierstorfer, MD
- 전화번호: 215-699-1929
- 이메일: mbstierstorfer@gmail.com
-
연락하다:
- Sally Iles, BSN, MBA
- 전화번호: 617-922-1130
- 이메일: SallyIles3@gmail.com
-
수석 연구원:
- Michael B Stierstorfer, MD
-
Philadelphia, Pennsylvania, 미국, 19104
- 모병
- University of Pennsylvania Dermatology
-
연락하다:
- Anna Kersh, MD, PhD
- 전화번호: 215-699-1929
- 이메일: admin@ibsfoodstudy.com
-
연락하다:
- Sally Iles, BA, MBA
- 전화번호: 617-922-1130
- 이메일: admin@ibsfoodstudy.com
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
활성 비교기: 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 |
|
가짜 비교기: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Post-Avoidance Diet Relative IBS Symptom Global Assessment
기간: 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.
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Michael B Stierstorfer, MD, North Wales Dermatology, PLLC
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- 1003A
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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