Ignite Creation Date:
2024-05-06 @ 6:12 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05576038
Status:
RECRUITING
Last Update Posted:
2023-10-16
First Post:
2022-10-03
Brief Title:
Tryptophan for Impaired AhR Signaling in Celiac Disease
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
Restoration of Impaired Microbiota-mediated Aryl Hydrocarbon Receptor Signaling in Celiac Disease by Oral Tryptophan Supplementation an Exploratory Pilot Trial
Status:
RECRUITING
Status Verified Date:
2023-10
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:
TIARSCeD
Brief Summary:
This is a prospective randomized double-blind placebo-controlled exploratory trial to evaluate the effect of L-tryptophan supplementation on celiac-related symptoms in individuals who have biopsy-confirmed celiac disease CeD and symptoms non-responsive to a gluten-free diet GFD Fifty participants aged 18 to 75 years who self-report persistent CeD-related symptoms despite taking a GFD for more than 1 year and who score 40 on the Celiac Symptom Index CSI will be randomized to receive L-tryptophan or placebo for 3 weeks
Detailed Description:
At Visit 1 consented participants will receive study instructions and be randomized 11 to L-tryptophan or placebo SimpleCap A dietitian will counsel all 50 participants on how to maintain a low tryptophan gluten-free diet This diet provides an adequate intake of protein 50 gday and energy 1800 kcalday while limiting the consumption of high tryptophan-containing foods Study participants will receive all their intervention capsules at Visit 1 to be taken for 3 weeks starting the day after Visit 2 At Visits 2 and 3 just before and after the intervention participants will complete dietary and symptom questionnaires provide blood stool and urine samples and undergo upper endoscopy to obtain aspirates from the second part of the duodenum using a sterile catheter followed by six duodenal biopsies 2 from the first part bulb and 4 from the second part of the duodenum Dietary compliance will be assessed 3-day recalls which will further be analysed by using ESHA Food Processor a Nutritional Analysis Software
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