Effect of Acute and Sub-acute Administration of Gluten on Extra-intestinal and Gastrointestinal Symptoms in Patients With Non-coeliac Gluten Sensitivity

Universitaire Ziekenhuizen KU Leuven20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

NCGS Gluten

Interventions

GlutenOTHER

Tereos

PlaceboOTHER

Nestlé Health Science

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (2)

TARGID

Leuven, Vlaams-Brabant, Belgium

RECRUITING

Jan Tack

Leuven, Belgium

RECRUITING

Outcomes

Primary Outcomes

The effect of gluten acutely and sub-acutely on extraintestinal symptoms in NCGS patients measured on the Positive and Negative Affect Schedule

Change from baseline. Scores can be 'very slightly or not at all', 'a little', 'moderately', 'quite a bit', 'extremely'

Time frame: 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)

The effect of gluten acutely and sub-acutely on extraintestinal symptoms in NCGS patients measured on the Profile of Mood State

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.

Time frame: 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

The effect of gluten acutely and sub-acutely on gastrointestinal symptoms in NCGS patients measured on the visual analogue scale for gastrointestinal symptoms

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.

Time frame: 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)

Effect of acute and sub-acute gluten administration on intestinal permeability (lactulose mannitol ratio)

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.

Time frame: 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)

Data from ClinicalTrials.gov

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