Clinical trial NCT03798249: Effect of Acute and Sub-acute Administration of Gluten on Extra-intestinal and Gastrointestinal Symptoms in Patients With Non-coeliac Gluten Sensitivity
Official title: Effect of Acute and Sub-acute Administration of Gluten on Extra-intestinal and Gastrointestinal Symptoms in Patients With Non-coeliac Gluten Sensitivity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: NCGS
Gluten
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: single-blinded, randomised - controlled, crossover
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The effect of gluten acutely and sub-acutely on extraintestinal symptoms in NCGS patients measured on the Positive and Negative Affect Schedule
timeFrame: 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)
measure: The effect of gluten acutely and sub-acutely on extraintestinal symptoms in NCGS patients measured on the Profile of Mood State
timeFrame: 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)
Secondary outcomes:
measure: The effect of gluten acutely and sub-acutely on gastrointestinal symptoms in NCGS patients measured on the visual analogue scale for gastrointestinal symptoms
timeFrame: 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)
measure: Effect of acute and sub-acute gluten administration on intestinal permeability (lactulose mannitol ratio)
timeFrame: 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)
measure: Effect of acute and sub-acute gluten administration on high sensitive reactive protein levels in bloodsample
timeFrame: During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41)
measure: Effect of acute and sub-acute gluten administration on Lipopolysaccharide-Binding Protein levels in bloodsample
timeFrame: During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41)
measure: Effect of acute and sub-acute gluten administration on lipopolysaccharide levels in bloodsample
timeFrame: During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41)
measure: Effect of acute and sub-acute gluten administration on gut microbiota composition
timeFrame: 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
measure: Effect of acute and sub-acute gluten administration on cortisol awakening response
timeFrame: 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)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: TARGID
state: Vlaams-Brabant
city: Leuven
country: Belgium
facility: Jan Tack
Study officials:
References: