Gluten SensitivityNCT04247737
Gluten Free Diet in IBS
A study testing gluten free diet in people with Gluten Sensitivity, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gluten Sensitivity
- What is being tested?
- gluten free diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy controls without gastrointestinal Symptoms
- patients with irritable bowel Syndrome (Rome IV criteria)
Who cannot join
- inflammatory bowel disease (Crohn's disease, Ulcerative colitis)
- celiac disease
- wheat allergy
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Erlangen, 91052
About this study
Official title: Effect of a Gluten Free Diet in Patients With 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.
Read the detailed description
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.
- Conditions
- Gluten Sensitivity
- Being tested
- gluten free diet
- Keywords
- non-celiac glutensensitivity, irritable bowel syndrom
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gluten free dietOther
Participants keep a gluten free diet for six weeks
| Study group | Role | What they receive |
|---|---|---|
| gluten free diet | Experimental | six week gluten free diet Receives: Other: gluten free diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of inflammatory Stimulation of monocytes after gluten exposure
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)
Measured: six weeks
Differences in Stimulation of inflammatory Parameters between healthy controls and patients with irritable bowel disease (IBD)
Detection of differences in relative gene Expression of inflammatory parameters (IL-1ß and IL-6) between patients with IBD and healthy controls
Measured: six weeks
Secondary outcomes (3)
Effect of a gluten free diet on improvement of gastrointestinal symptoms
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)
Measured: six weeks
Effect of the gluten free diet on Quality of life
Determination of the effect of a gluten free diet on Quality of Life using the Questionnaire psychological index for well being.
Measured: six weeks
Determination of a subgroup of Patients with NCGS in IBS cohorte
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)
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start1 Oct 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gluten SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 25 healthy individuals and 150 patients with irritable bowel syndrome keep a gluten-free diet for six weeks
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yurdagül zopf, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247737
- Sponsor's protocol ID
- IBS GFD
- Status last verified
- Feb 2022
- First submitted
- 16 Sep 2019
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Gluten Free Diet in Patients With IBS
- ClinicalTrials.gov ID
- NCT04247737
- Acronym / sponsor ID
- IBS GFD
- Conditions
- Gluten Sensitivity
- Keywords
- non-celiac glutensensitivity, irritable bowel syndrom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 25 healthy individuals and 150 patients with irritable bowel syndrome keep a gluten-free diet for six weeks
| Arm | Type | Receives |
|---|---|---|
| gluten free diet | Experimental | Other: gluten free dietsix week gluten free diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy controls without gastrointestinal Symptoms
- patients with irritable bowel Syndrome (Rome IV criteria)
Key exclusion criteria (4 listed)
- inflammatory bowel disease (Crohn's disease, Ulcerative colitis)
- celiac disease
- wheat allergy
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gluten free dietParticipants keep a gluten free diet for six weeks | Other | gluten free diet |
Primary outcome
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)
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
3 secondary outcomes
Effect of a gluten free diet on improvement of gastrointestinal symptoms
Time frame: six weeks
Effect of the gluten free diet on Quality of life
Time frame: six weeks
Determination of a subgroup of Patients with NCGS in IBS cohorte
Time frame: six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Individual participant dataSharing planned: No
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Celiac Disease, Gluten Sensitivity
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Dietary Approach to Mild-to-moderate Psoriasis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gluten free diet in people with Gluten Sensitivity, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of inflammatory Stimulation of monocytes after gluten exposure (time frame: six weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2022; AzTrials last refreshed its copy on 1 Nov 2026.