Wheat sensitivity and functional dyspepsia dietary trial and challenge protocol

Not Applicable

Recruiting

• Conditions: Functional dyspepsia; Non-coeliac wheat sensitivity; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12620001030965
• Lead Sponsor: The University of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-12
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

1.Adults aged >18 years
2.Males and females
3.Functional dyspepsia; diagnosed by Rome III criteria
4.Were consuming a normal gluten and normal FODMAP containing diet for prior to their scheduled endoscopy and serum sample collection (as determined by the dietary evaluation using food frequency questionnaires and 24 hour recall questionnaire collected in phase 1)

Exclusion Criteria

1.Inflammatory bowel disease
2.Coeliac disease; negative TTG and/or absence of villous atrophy D2 biopsy at endoscopy
3.Current or previous gastrointestinal malignancy
4.Peptic ulcer disease
5.Systemic inflammatory condition
6.Diabetes mellitus
7.Wheat allergy; positive IgE specific serum test
8.Food avoidance as determined by dietary evaluation in phase 1 of the study
9.Immunosuppression
10.Active infection
11.Pregnant patients

Study & Design

• Study Type: Interventional
• Study Design: Not specified