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

Primary Purpose

NCGS, Gluten

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Gluten
Placebo
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for NCGS

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • TARGIDRecruiting
  • Jan TackRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Gluten

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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'
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.

Secondary Outcome Measures

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.
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.
Effect of acute and sub-acute gluten administration on high sensitive reactive protein levels in bloodsample
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-Binding Protein levels in bloodsample
Change in lipopolysaccharide-binding protein levels measured at day 0, day 21 and day 41
Effect of acute and sub-acute gluten administration on lipopolysaccharide levels in bloodsample
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
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
Change in cortisol levels between gluten and placebo administration (saliva samples). Measured using an ELISA assay.

Full Information

First Posted
October 11, 2018
Last Updated
January 7, 2019
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT03798249
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 11, 2017 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NCGS, Gluten

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
single-blinded, randomised - controlled, crossover
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gluten
Arm Type
Active Comparator
Arm Description
Patients will receive acutely 16 g of gluten and 2 muffins glutenfree with 8 g of gluten, twice a day, during 5 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive acutely 16 g of whey protein and 2 glutenfree muffins, twice a day, during 5 days
Intervention Type
Other
Intervention Name(s)
Gluten
Intervention Description
Tereos
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Nestlé Health Science
Primary Outcome Measure Information:
Title
The effect of gluten acutely and sub-acutely on extraintestinal symptoms in NCGS patients measured on the Positive and Negative Affect Schedule
Description
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)
Title
The effect of gluten acutely and sub-acutely on extraintestinal symptoms in NCGS patients measured on the Profile of Mood State
Description
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 Outcome Measure Information:
Title
The effect of gluten acutely and sub-acutely on gastrointestinal symptoms in NCGS patients measured on the visual analogue scale for gastrointestinal symptoms
Description
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)
Title
Effect of acute and sub-acute gluten administration on intestinal permeability (lactulose mannitol ratio)
Description
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)
Title
Effect of acute and sub-acute gluten administration on high sensitive reactive protein levels in bloodsample
Description
Change in high sensitive reactive protein levels measured at day 0, day 21 and day 41
Time Frame
During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41)
Title
Effect of acute and sub-acute gluten administration on Lipopolysaccharide-Binding Protein levels in bloodsample
Description
Change in lipopolysaccharide-binding protein levels measured at day 0, day 21 and day 41
Time Frame
During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41)
Title
Effect of acute and sub-acute gluten administration on lipopolysaccharide levels in bloodsample
Description
Change in lipopolysaccharide levels measured at day 0, day 21 and day 41
Time Frame
During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41)
Title
Effect of acute and sub-acute gluten administration on gut microbiota composition
Description
Change in gut microbiota composition (compared to day 0) with focus on: Bifidobacterium, Lactobacillus, Enterobacteriaceae, E. coli (stool samples)
Time Frame
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
Title
Effect of acute and sub-acute gluten administration on cortisol awakening response
Description
Change in cortisol levels between gluten and placebo administration (saliva samples). Measured using an ELISA assay.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
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
Facility Information:
Facility Name
TARGID
City
Leuven
State/Province
Vlaams-Brabant
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annelies Geeraerts
Phone
016377034
Email
Annelies.Geeraerts@kuleuven.be
Facility Name
Jan Tack
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Tack
Phone
498797124
Email
jan.tack@med.kuleuven.be

12. IPD Sharing Statement

Learn more about this trial

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

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