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

Gluten Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03798249
• Other study ID #: S60127
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2017
• Est. completion date: January 2022

Study information

• Verified date: January 2019
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Gluten
• NCGS

Intervention

Other:
• Gluten
Tereos
• Placebo
Nestlé Health Science

Locations

Country	Name	City	State
Belgium	Jan Tack	Leuven
Belgium	TARGID	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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.	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	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.	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)
Secondary	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	During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41)
Secondary	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	During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41)
Secondary	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	During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41)
Secondary	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)	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
Secondary	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.	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)