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Completed

NCT Number: NCT03268720

Influence of the Immunosystem in Non-celiac Glutensensitivity

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.

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Key information

Conditions

Gluten Sensitivity Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg

Erlangen, 91052, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy controls
  • patients with glutensensitivity

Exclusion criteria

  • patients with glutensensitivity but without celiac disease or wheat allergy

Treatment and study plan

FODMAP low diet

Other

2 week FODMAP low diet

Gluten-free diet

Other

2 week gluten-free diet

Primary outcomes

  1. Determination of clinical symptomatics

    Time frame: 2 weeks

    Analysis of the improvement of clinical symptoms according to gastrointestinal symptom Rating score

  2. Determination of psychological symptoms

    Time frame: 2 weeks

    Improvement of well-being by questionnaire psychological General well-being index

Secondary outcomes

  1. Nutrition Analysis for energy intake and nutritional composition by questionnaire Freiburger Nutrition protocol

    Time frame: 2 weeks

    Determination of nutrient intake according to questionnaire Freiburger Nutrition protocol. The questionnaire allows the detailed determination of energy intake, carbohydrates, fatty acids, and Protein.

  2. Intraepithelial lymphocytes

    Time frame: 4 weeks

    numbers of intraepithelial lymphocytes in duodenal mucosa

  3. Goblet cells

    Time frame: 4 weeks

    numbers of Goblet cells in duodenal mucosa

  4. microbiome

    Time frame: 2 weeks

    Analysis of microbiota pattern

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Acronym: NCGS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 31, 2017
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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