Gluten SensitivityNCGSNCT03268720
Influence of the Immunosystem in Non-celiac Glutensensitivity
A study testing FODMAP low diet and 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 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. 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?
- FODMAP low diet and gluten-free diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to Dec 2016
- 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
- patients with glutensensitivity
Who cannot join
- patients with glutensensitivity but without celiac disease or wheat allergy
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
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.
Read the 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.
- Conditions
- Gluten Sensitivity
- Being tested
- FODMAP low diet, gluten-free diet
- Keywords
- gluten sensitivity, gluten-free diet, FODMAP diet, microbiome
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FODMAP low dietOther
2 week FODMAP low diet
gluten-free dietOther
2 week gluten-free diet
| Study group | Role | What they receive |
|---|---|---|
| healthy controls | Other | FODMAP low diet gluten-free diet Receives: Other: FODMAP low diet; Other: gluten-free diet |
| NCGS patients | Other | FODMAP low diet gluten-free diet Receives: Other: FODMAP low diet; Other: gluten-free diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of clinical symptomatics
Analysis of the improvement of clinical symptoms according to gastrointestinal symptom Rating score
Measured: 2 weeks
Determination of psychological symptoms
Improvement of well-being by questionnaire psychological General well-being index
Measured: 2 weeks
Secondary outcomes (4)
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.
Measured: 2 weeks
Intraepithelial lymphocytes
numbers of intraepithelial lymphocytes in duodenal mucosa
Measured: 4 weeks
Goblet cells
numbers of Goblet cells in duodenal mucosa
Measured: 4 weeks
microbiome
Analysis of microbiota pattern
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study startApr 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gluten SensitivityStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 29 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
- NCT03268720
- Sponsor's protocol ID
- Glutensensitivity
- Acronym
- NCGS
- Status last verified
- Jul 2024
- First submitted
- 15 Aug 2017
- Last updated
- 5 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29653862
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Immunosystem in Non-celiac Glutensensitivity
- ClinicalTrials.gov ID
- NCT03268720
- Acronym / sponsor ID
- NCGS / Glutensensitivity
- Conditions
- Gluten Sensitivity
- Keywords
- gluten sensitivity, gluten-free diet, FODMAP diet, microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 31 Aug 2017 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants consume a two week lasting low FODMAP diet, followed by 5 days washout, and subsequent two week gluten-free diet.
| Arm | Type | Receives |
|---|---|---|
| healthy controls | Other | Other: FODMAP low diet, Other: gluten-free dietFODMAP low diet gluten-free diet |
| NCGS patients | Other | Other: FODMAP low diet, Other: gluten-free dietFODMAP low diet 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
- patients with glutensensitivity
Key exclusion criteria (1 listed)
- patients with glutensensitivity but without celiac disease or wheat allergy
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 |
|---|---|---|
| FODMAP low diet2 week FODMAP low diet | Other | NCGS patients, healthy controls |
| gluten-free diet2 week gluten-free diet | Other | NCGS patients, healthy controls |
Primary outcome
Determination of clinical symptomatics
Time frame: 2 weeks
Analysis of the improvement of clinical symptoms according to gastrointestinal symptom Rating score
Determination of psychological symptoms
Time frame: 2 weeks
Improvement of well-being by questionnaire psychological General well-being index
4 secondary outcomes
Nutrition Analysis for energy intake and nutritional composition by questionnaire Freiburger Nutrition protocol
Time frame: 2 weeks
Intraepithelial lymphocytes
Time frame: 4 weeks
Goblet cells
Time frame: 4 weeks
microbiome
Time frame: 2 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 5 Jul 2024.
- Derived from this study: PubMed 29653862Dieterich 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.
- Individual participant dataSharing planned: No
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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 FODMAP low diet and 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 1 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 5 Jul 2024. 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 clinical symptomatics (time frame: 2 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?
On the ClinicalTrials.gov record for NCT03268720, which also lists 1 linked publication.
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 5 Jul 2024.