Postprandial Lipids in IBS and Nutritional Treatment - Trial NCT05016596
Access comprehensive clinical trial information for NCT05016596 through Pure Global AI's free database. This phase not specified trial is sponsored by Wageningen University and Research and is currently Completed. The study focuses on IBS - Irritable Bowel Syndrome. Target enrollment is 20 participants.
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Study Focus
Sponsor & Location
Wageningen University and Research
Timeline & Enrollment
N/A
Nov 15, 2021
Apr 11, 2022
Primary Outcome
LPS_B,LBP_1,LPS_2,LPS_3,LPS_4,LPS_5
Summary
Irritable Bowel Syndrome (IBS) is a disease that affects a large number of people. Adequate
 treatment is difficult, partially due to the heterogeneity of the patients and the
 complicated pathology in which not all mechanisms are understood. Based on literature and in
 vitro screening within the public private IBSQUtrition consortium project, a turmeric
 supplement was selected for in vivo validation of its potential beneficial effects on
 fat-induced intestinal barrier disruption as measured with LPS translocation in IBS patients
 with a diarrhea-predominant subtype (IBS-D).
 
 The primary objective of this study is to determine the effect of turmeric supplementation on
 LPS translocation in IBS-D patients after a high-fat challenge. The secondary objective of
 this study is to determine the effect of turmeric supplementation on gastrointestinal
 complaints and LPS-related biomarkers in IBS-D patients after a high-fat challenge.
 
 In this double-blind, randomized, placebo-controlled cross-over trial 20 adult (18-70 yrs)
 IBS-D patients will be included.
 
 Study participants have to invest about 16 hours of their time in this study. They will visit
 the research facility three times. The risks for participation are very small if not
 negligible. Consumption of high amounts of saturated fat may cause some gastro-intestinal
 discomfort. Blood sampling will be performed via a cannula and the insertion can be a bit
 painful and may cause a bruise. The amount of blood that is drawn from participants is
 relatively small and within acceptable limits.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05016596
Non-Device Trial