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

NCT03798249 | Unknown

• 1 other identifier: S60127
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

NCGS; Gluten

Outcome Measures

Primary Outcomes (2)

• 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'

  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.

  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 (7)

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

  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)

  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)

• Effect of acute and sub-acute gluten administration on high sensitive reactive protein levels in bloodsample

  During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41)

• Effect of acute and sub-acute gluten administration on Lipopolysaccharide-Binding Protein levels in bloodsample

  During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41)

• Effect of acute and sub-acute gluten administration on lipopolysaccharide levels in bloodsample

  During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41)

Study Arms (2)

Gluten

ACTIVE COMPARATOR

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

Other: Gluten

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Gluten OTHER

Tereos

Gluten

Placebo OTHER

Nestlé Health Science

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (2)

TARGID

Leuven, Vlaams-Brabant, Belgium

RECRUITING

Jan Tack

Leuven, 3000, Belgium

RECRUITING

Related Publications (1)

• Iven J, Geeraerts A, Vanuytsel T, Tack J, Van Oudenhove L, Biesiekierski JR. Impact of Acute and Sub-Acute Gluten Exposure on Gastrointestinal Symptoms and Psychological Responses in Non-Coeliac Gluten Sensitivity: A Randomised Crossover Study. United European Gastroenterol J. 2025 Sep;13(7):1295-1306. doi: 10.1002/ueg2.70014. Epub 2025 Mar 26.

  PMID: 40138597 DERIVED

MeSH Terms

Interventions

Glutens

Intervention Hierarchy (Ancestors)

Prolamins; Grain Proteins; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Seed Storage Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: single-blinded, randomised - controlled, crossover

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: January 9, 2019
• Study Start: May 11, 2017
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

BE (2)