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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-11

Study Completion Date

2022-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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NCGS Gluten

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

single-blinded, randomised - controlled, crossover

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Gluten

Patients will receive acutely 16 g of gluten and 2 muffins glutenfree with 8 g of gluten, twice a day, during 5 days

Group Type ACTIVE_COMPARATOR

Gluten

Intervention Type OTHER

Tereos

Placebo

Patients will receive acutely 16 g of whey protein and 2 glutenfree muffins, twice a day, during 5 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Nestlé Health Science

Interventions

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Gluten

Tereos

Intervention Type OTHER

Placebo

Nestlé Health Science

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No