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NCT Number: NCT04247737

Gluten Free Diet in IBS

Patients with irritable bowel syndrome (IBS) often benefit from dietary changes. The effect of a gluten-free diet (GFD) on clinical symptom improvement and psychological well-being will be checked in patients with IBS. In addition, the stimulatory potential of gluten on peripheral blood monocytes will be determined. Responders will be provoked with gluten containing bars or placebo bars to confirm the diagnosis of non-celiac glutensenstitivity.

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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 irritable bowel syndrome (IBS) often benefit from dietary changes. Since it has been shown that a gluten free diet (GFD) often alleviates the clinical symptoms, an overlap between patients with IBS and non-celiac glutensensitivity is assumed. The study includes 25 healthy individuals and 150 patients with IBS taking a six week GFD. Participants fill in questionnaires to determine clinical symptoms and psychological well being at the beginning and end of the dietary intervention. Patients with symptom relief under diet are further provoked in a double-blind placebo-controlled study with gluten or placebo containing bars for three weeks, separated by two weeks of washout to diagnosis of NCGS.

In addition, peripheral mononuclear cells are isolated at the beginning and end of the diet and the stimulating potential of wheat gluten is analyzed.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy controls without gastrointestinal Symptoms
  • patients with irritable bowel Syndrome (Rome IV criteria)

Exclusion criteria

  • inflammatory bowel disease (Crohn's disease, Ulcerative colitis)
  • celiac disease
  • wheat allergy
  • pregnancy

Treatment and study plan

Gluten free diet

Other

Participants keep a gluten free diet for six weeks

Primary outcomes

  1. Determination of inflammatory Stimulation of monocytes after gluten exposure

    Time frame: six weeks

    Real-time PCR is used to determine the fold Change of gene expression of Interleukins IL-1ß and IL-6 after 24 hours of stimulation of peripheral monocytes with gluten Fragments (0,5 mg/ml)

  2. Differences in Stimulation of inflammatory Parameters between healthy controls and patients with irritable bowel disease (IBD)

    Time frame: six weeks

    Detection of differences in relative gene Expression of inflammatory parameters (IL-1ß and IL-6) between patients with IBD and healthy controls

Secondary outcomes

  1. Effect of a gluten free diet on improvement of gastrointestinal symptoms

    Time frame: six weeks

    Detection of patients with clinical improvement during gluten free diet, Determination of patients with at least >30% improvement in main gastrointestinal symptoms according the questionnaire for gastrointestinal symptomes (IBS-SSS)

  2. Effect of the gluten free diet on Quality of life

    Time frame: six weeks

    Determination of the effect of a gluten free diet on Quality of Life using the Questionnaire psychological index for well being.

  3. Determination of a subgroup of Patients with NCGS in IBS cohorte

    Time frame: six weeks

    Detection of patients with IBS that profite from a gluten free diet with Clinical improvement. Determination of the percentage of patients with NCGS compared to whole Population (n=150)

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

Effect of a Gluten Free Diet in Patients With IBS

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 30, 2020
Registry last updated
Feb 21, 2022

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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