Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288672
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-25
Brief Title:
IBS Skin Patch Test Food Allergy Study
Sponsor:
IBS-80 LLC
Organization:
IBS-80 LLC
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multi-Center Study of Patch Test-Guided Type 4 Food Allergen Dietary Avoidance for Irritable Bowel Syndrome
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 foods to which they are allergic the 34true34 avoidance diet or foods to which the testing did not show an allergy this is called the 34sham34 avoidance diet There is a 5050 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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None