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Gluten and (Extra-)Intestinal Symptoms in NCGS (WoW)

Primary Purpose

Non-celiac Gluten Sensitivity

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Expectancy and gluten

About this trial

This is an interventional basic science trial for Non-celiac Gluten Sensitivity focused on measuring Non-Coeliac Gluten Sensitivity, NCGS, Gluten, Gastrointestinal symptoms

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Develops self-reported GI symptoms within 8 hours after a single intake of gluten-containing products, without a diagnosis of an organic GI disease; Following of willing to follow a gluten-free or gluten-restricting diet (based on a gluten-free dietary compliance questionnaire of Biagi et al. (only group 2, 3 and 4 will be eligible), for at least 1 week prior to study participation and willing to continue with this throughout the study; Asymptomatic or only mildly symptomatic (overall (GI) symptom score with VAS < 30mm) while on the gluten-free diet; Willing to participate in a study in which they have to consume 4 slices of gluten-containing or gluten-free bread for breakfast and lunch during the test day; Willing and able to give written informed consent and to understand, participate and comply with the research project requirements. Exclusion Criteria: Coeliac disease; Wheat allergy; Presence of an organic GI disease (such as inflammatory bowel disease) or other disease which may interfere with NCGS symptoms (upon judgment of the physician clinical investigator); Previous major abdominal surgery or radiotherapy interfering with GI function: Uncomplicated appendectomy, cholecystectomy and hysterectomy allowed unless within the past 6 months; Other surgery may be allowed based upon judgment of the physician-clinical investigator; Use of medication potentially influencing GI function and/or NCGS symptoms is allowed, provided that dosing has been stable for > 6 weeks before enrolment; Administration of antibiotics, probiotic or prebiotic supplements, investigational drugs or participation in any scientific intervention study, which may interfere with this study (to be decided by the principle investigator), in the 14 days prior to the study Excessive use of alcohol (>15 alcoholic units per week), or other drugs; Plan to lose weight or follow a specific diet within the study period; Any malignancy; Pregnancy or breastfeeding; Insufficient fluency of the Dutch (for Maastricht and Wageningen) or Englisch (for Leeds) language.

Sites / Locations

Maastricht University
Wageningen University
University of Leeds

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

E+ G+

E+ G-

E- G+

E- G-

Arm Description

Participants with the expectation of receiving gluten-containing bread and actually receiving gluten-containing oat bread during the test day.

Participants with the expectation of receiving gluten-containing bread, but actually receiving gluten-free oat bread during the test day.

Participants with the expectation of receiving gluten-free bread but actually receiving gluten-containing oat bread during the test day.

Participants with the expectation of receiving gluten-free bread and actually receiving gluten-free oat bread during the test day.

Outcomes

Primary Outcome Measures

Overall gastrointestinal symptom score (short term)

Change from baseline, measured on a Visual Analogue Scale ranged from 0-100, in which 0 is absence of symptoms and 100 is severe symptoms.

Secondary Outcome Measures

Individual gastrointestinal symptom scores (short term)

Change from baseline, measured on a Visual Analogue Scale ranged from 0-100, in which 0 is absence of symptoms and 100 is severe symptoms. Parameters: abdominal pain, abdominal discomfort, belching, bloating, flatulence, diarrhoea, constipation, urge to empty bowel, fullness, nausea.

Individual extra-intestinal symptom scores (short term)

Change from baseline, measured on a Visual Analogue Scale ranged from 0-100, in which 0 is absence of symptoms and 100 is severe symptoms. Parameters: tiredness, headache, foggy mind

Average stool frequency and consistency (short term)

Bristol Stool Scale, a validated scale for faecal frequency and consistency, by classifying faeces into seven groups. Type 1: separate hard lumps, like nuts (hard to pass); Type 2: sausage-shaped but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear-cut edges (passed easily); Type 6: fluffy pieces with ragged edges, a mushy stool; Type 7: watery, no solid pieces / entirely liquid. Type 1-2 indicate constipation, type 3-4 are ideal stools as they are easier to pass, and type 5-7 may indicate diarrhoea and urgency.

Mood (short term)

Change from baseline. Mood is measured by the Positive and Negative Affective Schedule (PANAS) questionnaire.

Overall and individual gastrointestinal symptom score (long-term)

Change from baseline, measured on a Visual Analogue Scale ranged from 0-100, in which 0 is absence of symptoms and 100 is severe symptoms. Parameters: overall gastrointestinal symtoms, abdominal pain, abdominal discomfort, belching, bloating, flatulence, diarrhoea, constipation, urge to empty bowel, fullness, nausea.

Individual extra-intestinal symptom scores (long term)

Change from baseline, measured on a Visual Analogue Scale ranged from 0-100, in which 0 is absence of symptoms and 100 is severe symptoms. Parameters: tiredness, headache, foggy mind

Average stool frequency and consistency (long term)

Mood (long term)

Change from baseline. Mood is measured by the Positive and Negative Affective Schedule (PANAS) questionnaire.

Full Information

NCT ID

NCT05779358

First Posted

March 9, 2023

Last Updated

March 9, 2023

Sponsor

Maastricht University

Collaborators

University of Leeds, Wageningen University

1. Study Identification

Unique Protocol Identification Number

NCT05779358

Brief Title

Gluten and (Extra-)Intestinal Symptoms in NCGS

Acronym

WoW

Official Title

The Effects of Bread Consumption on Intestinal and Extra-intestinal Symptoms in Non-coeliac Gluten Sensitivity

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

October 19, 2018 (Actual)

Primary Completion Date

January 31, 2022 (Actual)

Study Completion Date

February 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maastricht University

Collaborators

University of Leeds, Wageningen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The goal of this randomized, double-blind, placebo-controlled study is to investigate the effect of expectancy related to gluten consumption versus actual gluten intake on overall GI symptoms in individuals with non-coeliac gluten sensitivity (NCGS) The main questions it aims to answer are: what is the effect of consumer expectancy, related to either gluten-containing or gluten-free oat bread, on short-term (within 8 hours) overall GI symptoms in individuals with NCGS? what is the effect of actual gluten intake on short-term (within 8 hours) overall GI symptoms in individuals with NCGS Participants will be randomised into four groups: Participants with the expectation of receiving gluten-containing bread and actually receiving gluten-containing oat bread during the test day. (E+ G+) Participants with the expectation of receiving gluten-containing bread, but actually receiving gluten-free oat bread during the test day. (E+ G-) Participants with the expectation of receiving gluten-free bread but actually receiving gluten-containing oat bread during the test day. (E- G+) Participants with the expectation of receiving gluten-free bread and actually receiving gluten-free oat bread during the test day. (E- G-)

Detailed Description

One on-site test, starting with baseline measurement (T = 0). Thereafter, subjects are told that they will receive two slices of gluten-containing bread (E+) or gluten-free bread (E-). Consequently, they receive breakfast with two slices of bread (gluten-containing (G+) or gluten-free (G-)). After breakfast, questionnaires will be completed every hour for 8 hours. After T = 4 hours, participants receive lunch with two slices of the same bread, combined with the same expectancy, that they received at breakfast. Follow-up measurements include the same questionnaires at the end of day 1 (from end of test day until they go to sleep), at the end of day 2 and at the end of day 3.

6. Conditions and Keywords

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

Non-celiac Gluten Sensitivity

Keywords

Non-Coeliac Gluten Sensitivity, NCGS, Gluten, Gastrointestinal symptoms

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Investigator and outcomes assessor know expectancy (E+ or E-) but is blinded to the actual gluten intervention (G+ or G-). Participants are told the expectancy, but are unaware of the actual nature of the intervention: they are unaware that there is a 50% chance of receiving either G+ or G- bread, regardless of what they were told.

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

E+ G+

Arm Type

Active Comparator

Arm Description

Participants with the expectation of receiving gluten-containing bread and actually receiving gluten-containing oat bread during the test day.

Arm Title

E+ G-

Arm Type

Active Comparator

Arm Description

Participants with the expectation of receiving gluten-containing bread, but actually receiving gluten-free oat bread during the test day.

Arm Title

E- G+

Arm Type

Active Comparator

Arm Description

Participants with the expectation of receiving gluten-free bread but actually receiving gluten-containing oat bread during the test day.

Arm Title

E- G-

Arm Type

Placebo Comparator

Arm Description

Participants with the expectation of receiving gluten-free bread and actually receiving gluten-free oat bread during the test day.

Intervention Type

Other

Intervention Name(s)

Expectancy and gluten

Intervention Description

Effect of expectancy to receive gluten and/or actual gluten intake

Primary Outcome Measure Information:

Title

Overall gastrointestinal symptom score (short term)

Description

Change from baseline, measured on a Visual Analogue Scale ranged from 0-100, in which 0 is absence of symptoms and 100 is severe symptoms.

Time Frame

Test day: baseline (T = 0 hours), hourly after breakfast (T = 1 hour until T = 4 hours), and hourly after lunch (T = 5 hours until T = 8 hours)

Secondary Outcome Measure Information:

Title

Individual gastrointestinal symptom scores (short term)

Description

Time Frame

Test day: baseline (T = 0 hours), hourly after breakfast (T = 1 hour until T = 4 hours), and hourly after lunch (T = 5 hours until T = 8 hours)

Title

Individual extra-intestinal symptom scores (short term)

Description

Change from baseline, measured on a Visual Analogue Scale ranged from 0-100, in which 0 is absence of symptoms and 100 is severe symptoms. Parameters: tiredness, headache, foggy mind

Time Frame

Test day: baseline (T = 0 hours), hourly after breakfast (T = 1 hour until T = 4 hours), and hourly after lunch (T = 5 hours until T = 8 hours)

Title

Average stool frequency and consistency (short term)

Description

Time Frame

Test day: baseline (T = 0 hours), hourly after breakfast (T = 1 hour until T = 4 hours), and hourly after lunch (T = 5 hours until T = 8 hours)

Title

Mood (short term)

Description

Change from baseline. Mood is measured by the Positive and Negative Affective Schedule (PANAS) questionnaire.

Time Frame

Test day: baseline, every hour after breakfast (T = 1 hour until T = 8 hours)

Title

Overall and individual gastrointestinal symptom score (long-term)

Description

Time Frame

Follow-up: end of day 1 (time from end of test day (t = 8 hours) until end of that day), end of day 2, end of day 3

Title

Individual extra-intestinal symptom scores (long term)

Description

Change from baseline, measured on a Visual Analogue Scale ranged from 0-100, in which 0 is absence of symptoms and 100 is severe symptoms. Parameters: tiredness, headache, foggy mind

Time Frame

Follow-up: end of day 1 (time from end of test day (t = 8 hours) until end of that day), end of day 2, end of day 3

Title

Average stool frequency and consistency (long term)

Description

Time Frame

Follow-up: end of day 1 (time from end of test day (t = 8 hours) until end of that day), end of day 2, end of day 3

Title

Mood (long term)

Description

Change from baseline. Mood is measured by the Positive and Negative Affective Schedule (PANAS) questionnaire.

Time Frame

Follow-up: end of day 1 (time from end of test day (t = 8 hours) until end of that day), end of day 2, end of day 3

Other Pre-specified Outcome Measures:

Title

Participant characteristics in relation to NCGS

Description

To characterise NCGS subjects, data will be collected on medical history (e.g. surgery, GI diseases, medication use, allergies), demographic (e.g. age, gender, educational background, BMI, smoking, alcohol use), adherence to gluten-free diet, and psychosocial factors (relating to e.g. anxiety, depression, somatisation) using screening questionnaires.

Time Frame

Data on medical history, demographic factors and adherence to gluten-free diet during the screening visit as part of the screening process. Data on psychological factors will be collected after inclusion of subjects, before the start of the test day.

Title

Food intake and medication use

Description

To check for possible confounders of the follow-up days, a food and medication record will be kept during follow-up.

Time Frame

Follow-up: end of day 1 (time from end of test day (t = 8 hours) until end of that day), end of day 2, end of day 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daisy MAE Jonkers, Prof, PhD

Organizational Affiliation

Maastricht University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Louise Dye, Prof, PhD

Organizational Affiliation

University of Leeds

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maastricht University

City

Maastricht

Country

Netherlands

Facility Name

Wageningen University

City

Wageningen

Country

Netherlands

Facility Name

University of Leeds

City

Leeds

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Gluten and (Extra-)Intestinal Symptoms in NCGS

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