Gluten Sensitivity
Conditions
Keywords
non-celiac glutensensitivity, irritable bowel syndrom
Brief summary
Patients with irritable bowel syndrome (IBS) often benefit from dietary changes. The effect of a gluten-free diet (GFD) on clinical symptom improvement and psychological well-being will be checked in patients with IBS. In addition, the stimulatory potential of gluten on peripheral blood monocytes will be determined. Responders will be provoked with gluten containing bars or placebo bars to confirm the diagnosis of non-celiac glutensenstitivity.
Detailed description
Patients with irritable bowel syndrome (IBS) often benefit from dietary changes. Since it has been shown that a gluten free diet (GFD) often alleviates the clinical symptoms, an overlap between patients with IBS and non-celiac glutensensitivity is assumed. The study includes 25 healthy individuals and 150 patients with IBS taking a six week GFD. Participants fill in questionnaires to determine clinical symptoms and psychological well being at the beginning and end of the dietary intervention. Patients with symptom relief under diet are further provoked in a double-blind placebo-controlled study with gluten or placebo containing bars for three weeks, separated by two weeks of washout to diagnosis of NCGS. In addition, peripheral mononuclear cells are isolated at the beginning and end of the diet and the stimulating potential of wheat gluten is analyzed.
Interventions
OTHERgluten free diet
Participants keep a gluten free diet for six weeks
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
25 healthy individuals and 150 patients with irritable bowel syndrome keep a gluten-free diet for six weeks
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* healthy controls without gastrointestinal Symptoms * patients with irritable bowel Syndrome (Rome IV criteria)
Exclusion criteria
* inflammatory bowel disease (Crohn's disease, Ulcerative colitis) * celiac disease * wheat allergy * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of inflammatory Stimulation of monocytes after gluten exposure | six weeks | Real-time PCR is used to determine the fold Change of gene expression of Interleukins IL-1ß and IL-6 after 24 hours of stimulation of peripheral monocytes with gluten Fragments (0,5 mg/ml) |
| Differences in Stimulation of inflammatory Parameters between healthy controls and patients with irritable bowel disease (IBD) | six weeks | Detection of differences in relative gene Expression of inflammatory parameters (IL-1ß and IL-6) between patients with IBD and healthy controls |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of a gluten free diet on improvement of gastrointestinal symptoms | six weeks | Detection of patients with clinical improvement during gluten free diet, Determination of patients with at least \>30% improvement in main gastrointestinal symptoms according the questionnaire for gastrointestinal symptomes (IBS-SSS) |
| Effect of the gluten free diet on Quality of life | six weeks | Determination of the effect of a gluten free diet on Quality of Life using the Questionnaire psychological index for well being. |
| Determination of a subgroup of Patients with NCGS in IBS cohorte | six weeks | Detection of patients with IBS that profite from a gluten free diet with Clinical improvement. Determination of the percentage of patients with NCGS compared to whole Population (n=150) |
Countries
Germany
Outcome results
None listed