Phase
Condition
Lactose Intolerance
Gastrointestinal Diseases And Disorders
Colic
Treatment
True avoidance diet
Sham avoidance diet
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Irritable bowel syndrome diagnosed by a primary care provider, gastroenterologist orallergist; or meeting the Rome IV IBS diagnostic criteria by history and havingsuboptimally or poorly controlled IBS symptoms.
Exclusion
Exclusion Criteria:
- Under age 18 years
- Pregnant
- Severe rash
- Receiving any cortisone-containing or any of the following immunosuppressivemedications within two weeks prior to patch testing or plan to do so any time duringthe study: cyclosporine, mycophenylate mofetil, azathioprine, tacrolimus or otherswithin these classes of medications)
- Incapable of completing all parts of the 18-week screening period and study, includingfollowing 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 unwillingto discontinue the low FODMAP diet, if relevant, starting 1 week prior to the studyand for the study duration
- Refusal to shave back hair, if relevant 9) Receiving pharmacologic therapy for IBS thathas 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 diseaseincluding celiac disease, cirrhosis, gastrointestinal malignancy, inflammatory boweldisease, or diverticulitis, active within the prior 2 years. 13) Have a history ofgastrointestinal surgery (except appendectomy and cholecystectomy or gallbladder removal >6 months ago) 14) Have poorly controlled psychiatric disease such as severedepression (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 dayfor males) 16) Use illicit substances 17) Use high-dose opiates 18) Severe allergy toadhesive tape
Study Design
Study Description
Connect with a study center
Adult and Pediatric Dermatology
Marlborough, Massachusetts 01752
United StatesActive - Recruiting
Adult and Pediatric Dermatology
Westford, Massachusetts 01886
United StatesActive - Recruiting
Allergy & Asthma Care of New York
New York, New York 10016
United StatesSite Not Available
Modern Dermatology NYC
New York, New York 10016
United StatesActive - Recruiting
North Wales Dermatology, PLLC
North Wales, Pennsylvania 19454
United StatesActive - Recruiting
Shepherd Allergy
Barboursville, West Virginia 25504
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.