Ignite Creation Date:
2024-05-06 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05157867
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-27
First Post:
2021-10-06
Brief Title:
In Vivo Effects of Amylase Trypsin Inhibitors
Sponsor:
Maastricht University
Organization:
Maastricht University
Study Overview
Official Title:
In Vivo Effects of Amylase Trypsin Inhibitors From Wheat in the Human Gut Proof of Cause of Non-coeliac Wheat Sensitivity in Irritable Bowel Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
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:
ATI
Brief Summary:
Wheat is the most important staple food consumed in the Western world and provides beneficial health effects and functional properties Nevertheless an increasing proportion of the general population is avoiding or reducing its consumption of wheat products due to self-reported gastrointestinal GI symptoms such as patients with non-coeliac wheat sensitivity NCWS andor irritable bowel syndrome IBS There is increasing evidence that the amylase trypsin inhibitors ATIs accounting for up to 15 of wheat proteins play a role in the symptom generation in NCWS and IBS In vitro studies showed ATIs can induce an innate immune response via direct interaction with the toll-like receptor 4 TLR4 activating the TLR4-MD2-CD14 complex with subsequent release of pro-inflammatory cytokines These results were confirmed in mice Furthermore in mice ATIs triggered intestinal epithelial lymphocytosis and barrier dysfunction and modified microbiota composition and metabolism Thus far there have been no placebo-controlled studies investigating these effects of isolated ATIs in human subjects Understanding the role of ATIs in symptom generation in NCWS and IBS patients is important to provide these patients with appropriate dietary advice improving their quality of life and decreasing their risk of nutritional deficiencies
The investigators aim to perform a proof-of-concept study to assess the effect of ATIs on the intestinal barrier and immune function in healthy volunteers The investigators hypothesise that the ATIs either directly affect the intestinal barrier function or indirectly by activating an immune response via TLR4
The study conforms a randomized double-blind placebo-controlled cross-over design using healthy human volunteers male and female 18-65 years old Volunteers will each undergo two test days separated by a wash-out period of at least 4 weeks At the test day volunteers receive either isolated ATIs or placebo physiological saline ingested using a nasogastric intraduodenal feeding catheter
The investigators aim to perform a proof-of-concept study to assess the effect of ATIs on the intestinal barrier and immune function in healthy volunteers The investigators hypothesise that the ATIs either directly affect the intestinal barrier function or indirectly by activating an immune response via TLR4
The study conforms a randomized double-blind placebo-controlled cross-over design using healthy human volunteers male and female 18-65 years old Volunteers will each undergo two test days separated by a wash-out period of at least 4 weeks At the test day volunteers receive either isolated ATIs or placebo physiological saline ingested using a nasogastric intraduodenal feeding catheter
Detailed Description:
None
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