Effect of Acute and Sub-acute Administration of Gluten on Extra-intestinal and Gastrointestinal Symptoms in Patients With Non-coeliac Gluten Sensitivity
- Conditions
- NCGSGluten
- Interventions
- Other: PlaceboOther: Gluten
- Registration Number
- NCT03798249
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
The investigators will investigate the effects of acute and sub-acute administration of gluten on mood, intestinal permeability, gastrointestinal symptoms, gut microbiota and cortisol levels in NCGS patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
-
Non-coeliac gluten sensitivity patients
- Previous symptoms of IBS fulfilling Rome III criteria that self reportedly improved with a gluten-free diet
- Symptoms currently well controlled on a gluten-free diet
- Adherence to the gluten-free diet for at least 6 weeks prior to recruitment
- Coeliac disease excluded (either by absence of the HLA-DQ2 and HLA-DQ8 haplotype or by a normal duodenal biopsy (Marsh 0) performed at endoscopy while on a gluten-containing diet in individuals expressing the HLA-DQ2 or HLA-DQ8 haplotype)
- IgA anti-tissue-transglutaminase or IgG anti-deaminated gliadin peptide positive
-
Body Mass Index (BMI) of 20 - 25 kg/m2
-
Stable body weight for at least 3 months prior to the start of the study
-
Medical
- Coeliac disease
- Abdominal or thoracic surgery. Exception: appendectomy
- Gastrointestinal, endocrine or neurological diseases
- Cardiovascular, respiratory, renal or urinary diseases
- Hypertension
- Food or drug allergies
-
Psychiatric disorders
- Eating disorders
- Depressive disorders
- Anxiety disorders
- Psychotic disorders
-
Restraint or emotional eating
-
Medication on a regular basis, exception: oral contraception
-
History of cannabis use or any other drug of abuse for at least 12 months prior to the study
-
Alcohol abuse (more than 21 units of alcohol for men, more than 14 units for woman per week)
-
Pregnant or breastfeeding women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Patients will receive acutely 16 g of whey protein and 2 glutenfree muffins, twice a day, during 5 days Gluten Gluten Patients will receive acutely 16 g of gluten and 2 muffins glutenfree with 8 g of gluten, twice a day, during 5 days
- Primary Outcome Measures
Name Time Method The effect of gluten acutely and sub-acutely on extraintestinal symptoms in NCGS patients measured on the Positive and Negative Affect Schedule At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 20), after test visit 3 (at day 35), after test visit 4 (at day 40) Change from baseline. Scores can be 'very slightly or not at all', 'a little', 'moderately', 'quite a bit', 'extremely'
The effect of gluten acutely and sub-acutely on extraintestinal symptoms in NCGS patients measured on the Profile of Mood State At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 20), after test visit 3 (at day 35), after test visit 4 (at day 40) Scores are measured on the Visual Analogue Scale. Change from baseline. The scale is ranged 0 - 10, in which 0 no occurrence of the symptom and 10 a lot occurrence of the symptom. Measured at day 0, day 15, day 21, day 36 and day 41.
- Secondary Outcome Measures
Name Time Method The effect of gluten acutely and sub-acutely on gastrointestinal symptoms in NCGS patients measured on the visual analogue scale for gastrointestinal symptoms At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 20), after test visit 3 (at day 35), after test visit 4 (at day 40) With '0' no complaints and '10' a lot of complaints (change from baseline). Measured on the Visual Analogue Scale. Measured at day 0, day 15, day 21, day 36 and day 41.
Effect of acute and sub-acute gluten administration on intestinal permeability (lactulose mannitol ratio) At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 21), after test visit 3 (at day 36), after test visit 4 (at day 41) Change in intestinal permeability after gluten administration. In the urine we can measure the ratio lactulose/mannitol. This can be measured using High Performance Liquid Chromatography at day 0, day 15, day 21, day 36 and day 41.
Effect of acute and sub-acute gluten administration on Lipopolysaccharide-Binding Protein levels in bloodsample During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) Change in lipopolysaccharide-binding protein levels measured at day 0, day 21 and day 41
Effect of acute and sub-acute gluten administration on high sensitive reactive protein levels in bloodsample During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) Change in high sensitive reactive protein levels measured at day 0, day 21 and day 41
Effect of acute and sub-acute gluten administration on lipopolysaccharide levels in bloodsample During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) Change in lipopolysaccharide levels measured at day 0, day 21 and day 41
Effect of acute and sub-acute gluten administration on gut microbiota composition After test visit 0 (day 0), day 13 and day 14, after test visit 1 (day 15), day 16, 17, 18, 19 and 20, two days before test visit 3 (day 34 and 35), day 36, 37, 38, 39, 40 Change in gut microbiota composition (compared to day 0) with focus on: Bifidobacterium, Lactobacillus, Enterobacteriaceae, E. coli (stool samples)
Effect of acute and sub-acute gluten administration on cortisol awakening response Day before test visit 1 (day 14), test visit 1 (day 15), test visit 2 (day 21), day before test visit 3 (day 35), test visit 3 (day 36) and test visit 4 (day 41) Change in cortisol levels between gluten and placebo administration (saliva samples). Measured using an ELISA assay.
Trial Locations
- Locations (2)
TARGID
🇧🇪Leuven, Vlaams-Brabant, Belgium
Jan Tack
🇧🇪Leuven, Belgium