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The role of gluten as a cause of gastrointestinal symptoms and fatigue in patients who do not have coeliac disease

The role of wheat gluten in the genesis of gastrointestinal symptoms and fatigue in patients with non-coeliac gluten intolerance: Investigation of the gluten ‘intolerance’ threshold level.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000524099
Enrollment
37
Registered
2010-06-24
Start date
2010-03-11
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

The purpose of this study is to confirm that gluten-containing foods causes abdominal symptoms and fatigue in people who do not have coeliac disease and to investigate if these individuals can tolerate a low-dose of gluten.

Interventions

Arm 1: Whole wheat-gluten (16 grams of commercial gluten per day); and Arm 2: Whole wheat-gluten (2 grams of commercial gluten per day ). The study is a randomised, placebo-controlled, double-blinded cross-over study design of 9 weeks duration (including a two-week run-in period at the start), where eligible volunteers will be randomly allocated to receive one of the three treatment arms for 1 week, followed by a washout period of at least 2-weeks (or until symptoms induced during the previous

Arm 1: Whole wheat-gluten (16 grams of commercial gluten per day); and Arm 2: Whole wheat-gluten (2 grams of commercial gluten per day ). The study is a randomised, placebo-controlled, double-blinded cross-over study design of 9 weeks duration (including a two-week run-in period at the start), where eligible volunteers will be randomly allocated to receive one of the three treatment arms for 1 week, followed by a washout period of at least 2-weeks (or until symptoms induced during the previous dietary challenge have resolved), before crossing over to the next diet. Each volunteer will undertake all 3 treatment arms. All food will be provided where the gluten will be administered across the day in different meals (all baseline meals will be gluten-free and low in poorly absorbed fermentable carbohydrates).

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Met Rome III criteria for Irritable Bowel Syndrome (IBS) prior to implementation of gluten-free diet (GFD) 2. Current gastrointestinal (GI) symptoms well-controlled on a GFD 3. Adherent to a strict GFD for the previous 6 weeks. 4. Coeliac disease excluded by either normal duodenal histology while consuming a gluten-containing diet or by having a genotype that is inconsistent with coeliac disease (Human Leukocyte Antigen (HLA) -DQ2 and -DQ8 negative)

Exclusion criteria

1. Other significant GI disease (e.g., cirrhosis, inflammatory bowel disease) or other clinically significant co-morbidity. 2. Intake of non-steroidal anti-inflammatory drugs 3. Use of systemic immunosuppressant medication (e.g., prednisolone, methotrexate, thiopurines, anti-tumour necrosis factor drugs) 4. Excessive alcohol intake 5. Poorly controlled psychiatric disease 6. Unable to give written/informed consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026