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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?

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? - In vivo effects of amylase trypsin inhibitors (ATI study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52091
Enrollment
8
Registered
2021-11-24
Start date
2021-10-01
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-coeliac wheat sensitivity wheat sensitivity

Interventions

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 u

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1) No gastrointestinal complaints and/or disease 2) Age between 18-65 years 3) BMI between 20-30 kg/m2

Exclusion criteria

Exclusion criteria: 1) History of severe cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. 2) Use of medication, including nutritional supplements, except oral contraceptives, within 14 days prior to testing. 3) Administration of investigational drugs or participation in any scientific intervention study, which may interfere with this study (to be decided by the principal investigator), in the 180 days prior to the study. 4) Major abdominal surgery interfering with gastrointestinal function. 5) Pregnancy, lactation. 6) Excessive alcohol consumption, smoking, drug use. 7) Blood donation within 3 months before or after the study period. 8) Plan to lose weight or follow a specific diet within the study period.

Design outcomes

Primary

MeasureTime frame
Intestinal barrier function associated gene expression induced by ATIs.

Secondary

MeasureTime frame
Intestinal barrier function associated protein levels and blood markers Markers of immune activation: gene expression, tissue infiltration of immune cells, quantification immune cell populations and blood markers

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)