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ClinicalTrials.gov ID

NCT03798249

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

20Estimated

Last Update Posted

Jan 9, 2019Actual

Start Date

May 11, 2017Actual

Primary Completion Date

Jan 2022Estimated

Completion Date

Jan 2022Estimated

Official Title

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

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.

• NCGS
• Gluten

• Gluten
• Placebo

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Diagnostic

Allocation

Randomized

Interventional Model

Crossover Assignment

Masking

Single

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

jan.tack@med.kuleuven.be498797124