Influence of the Immunosystem in Non-celiac Glutensensitivity (NCGS)
Primary Purpose
Gluten Sensitivity
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
FODMAP low diet
gluten-free diet
Sponsored by
About this trial
This is an interventional basic science trial for Gluten Sensitivity focused on measuring gluten sensitivity, gluten-free diet, FODMAP diet, microbiome
Eligibility Criteria
Inclusion Criteria:
- healthy controls
- patients with glutensensitivity
Exclusion Criteria:
- patients with glutensensitivity but without celiac disease or wheat allergy
Sites / Locations
- Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
healthy controls
NCGS patients
Arm Description
FODMAP low diet gluten-free diet
FODMAP low diet gluten-free diet
Outcomes
Primary Outcome Measures
Determination of clinical symptomatics
Analysis of the improvement of clinical symptoms according to gastrointestinal symptom Rating score
Determination of psychological symptoms
Improvement of well-being by questionnaire psychological General well-being index
Secondary Outcome Measures
Nutrition Analysis for energy intake and nutritional composition by questionnaire Freiburger Nutrition protocol
Determination of nutrient intake according to questionnaire Freiburger Nutrition protocol. The questionnaire allows the detailed determination of energy intake, carbohydrates, fatty acids, and Protein.
Intraepithelial lymphocytes
numbers of intraepithelial lymphocytes in duodenal mucosa
Goblet cells
numbers of Goblet cells in duodenal mucosa
microbiome
Analysis of microbiota pattern
Full Information
NCT ID
NCT03268720
First Posted
August 15, 2017
Last Updated
August 29, 2017
Sponsor
University of Erlangen-Nürnberg Medical School
1. Study Identification
Unique Protocol Identification Number
NCT03268720
Brief Title
Influence of the Immunosystem in Non-celiac Glutensensitivity
Acronym
NCGS
Official Title
Influence of the Immunosystem in Non-celiac Glutensensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Patients with non-celiac gluten sensitivity (NCGS) complain about gastrointestinal and extraintestinal symptoms while consuming gluten-containing cereals. The symptoms strictly correlate with ingestion of gluten-containing cereals and disappear quickly under elimination diets. Till now, there are no specific markers to diagnose NCGS. This study aims to determine the effect of a low FODMAP diet (fermentable oligo-, di- and monosaccharides and polyols) and a glutenfree diet on the mucosal immunity, clinical symptoms, and psychological well-being. Furthermore, the influence of the diets on the microbiome will be analyzed.
Detailed Description
Patients with gluten-sensitivity are rigourously checked for wheat allergy and celiac disease. Genotyping for DQ2/8, serological detection of celiac specific antibodies, and gastroduodenoscopy are performed. Furthermore, a skin prick test and detection of wheat specific IgE are done.
After exclusion of celiac disease and wheat allergy patients are considered as patients with NCGS.
Patients and healthy controls are asked to consume a low FODMAP diet for two weeks, followed by a 5 day washout and subsequent two week gluten-free diet.
At the beginning and the end of each diet the participants fill in questionnaires concerning Nutrition (Freiburger Nutrition protocol), psychological well-being index (PGWB), gastrointestinal symptom Rating score (GSRS), and stool consistency (Bristol stool Chart). Furthermore, stool samples are selected at each time point to determine the microbial pattern.
NCGS patients with ongoing complaints will have a second gastroduodenoscopy at the end of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gluten Sensitivity
Keywords
gluten sensitivity, gluten-free diet, FODMAP diet, microbiome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Participants consume a two week lasting low FODMAP diet, followed by 5 days washout, and subsequent two week gluten-free diet.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
healthy controls
Arm Type
Other
Arm Description
FODMAP low diet gluten-free diet
Arm Title
NCGS patients
Arm Type
Other
Arm Description
FODMAP low diet gluten-free diet
Intervention Type
Other
Intervention Name(s)
FODMAP low diet
Intervention Description
2 week FODMAP low diet
Intervention Type
Other
Intervention Name(s)
gluten-free diet
Intervention Description
2 week gluten-free diet
Primary Outcome Measure Information:
Title
Determination of clinical symptomatics
Description
Analysis of the improvement of clinical symptoms according to gastrointestinal symptom Rating score
Time Frame
2 weeks
Title
Determination of psychological symptoms
Description
Improvement of well-being by questionnaire psychological General well-being index
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Nutrition Analysis for energy intake and nutritional composition by questionnaire Freiburger Nutrition protocol
Description
Determination of nutrient intake according to questionnaire Freiburger Nutrition protocol. The questionnaire allows the detailed determination of energy intake, carbohydrates, fatty acids, and Protein.
Time Frame
2 weeks
Title
Intraepithelial lymphocytes
Description
numbers of intraepithelial lymphocytes in duodenal mucosa
Time Frame
4 weeks
Title
Goblet cells
Description
numbers of Goblet cells in duodenal mucosa
Time Frame
4 weeks
Title
microbiome
Description
Analysis of microbiota pattern
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy controls
patients with glutensensitivity
Exclusion Criteria:
patients with glutensensitivity but without celiac disease or wheat allergy
Facility Information:
Facility Name
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29653862
Citation
Dieterich W, Schuppan D, Schink M, Schwappacher R, Wirtz S, Agaimy A, Neurath MF, Zopf Y. Influence of low FODMAP and gluten-free diets on disease activity and intestinal microbiota in patients with non-celiac gluten sensitivity. Clin Nutr. 2019 Apr;38(2):697-707. doi: 10.1016/j.clnu.2018.03.017. Epub 2018 Apr 4.
Results Reference
derived
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Influence of the Immunosystem in Non-celiac Glutensensitivity
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