Celiac DiseaseNCT03678935
Effect of FODMAP Restriction on Persistent GI-symptoms in Coeliac Patients
A study testing Low FODMAP diet in people with Celiac Disease and Irritable Bowel Syndrome, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The first aim of the study is to investigate the prevalence of persistent gastrointestinal symptoms and compliance with gluten-free diet and the intake of FODMAP in adult celiac patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Celiac Disease, Irritable Bowel Syndrome, Diet Modification
- What is being tested?
- Low FODMAP diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- 1 Oct 2018to 28 Jul 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coeliac disease
- Adherent to GFD for at least 12 months
- Strictly adherent to GFD
- Normal coeliac disease (CD) serology and duodenal biopsy (Marsh 0-1)
- Persistent GI-symptoms defined by GSRS-IBS score of 30 or more
- Living less than 2 hour from study centre
Who cannot join
- Pregnancy or lactating women
- Use of immunomodulating drugs in the last 3 months
- Use of anti-inflammatory drugs in the last 3 months
- Use of antacid drugs in the last 2 months
- Ongoing infection (mild infection such as upper airway infection is ok)
- Other chronical bowel disorder (except for IBS)
- Previous tried the LFD with guidance of a dietician
Trial locations and contacts
1 site in 1 country.
Norway1 site
Rikshospitalet-Radiumhospitalet HF, Oslo University Hospital
Oslo, Postboks PB 4950 Nydalen, 0424
About this study
Official title: Effect of Fermentable Oligo-, di-, and Monosaccharides and Polyols (FODMAP) Restriction on Persistent GI-symptoms in Coeliac Patients
The first aim of the study is to investigate the prevalence of persistent gastrointestinal symptoms and compliance with gluten-free diet and the intake of FODMAP in adult celiac patients.
A web-based survey wil be performed and thereafter a randomized controlled trial to test the effect of a FODMAP reduction in patients with celiac disease with irritable bowel-like symptoms.
Read the detailed description
Effect of FODMAP reduction in patients with celiac disease. Celiac disease is an immune-mediated disease that causes damage to the intestines. The condition affects 1-2% of the population, and the incidence is increasing. Treatment with gluten-free diet usually produces good results, yet there are many patients who have persistent gastrointestinal symptoms. Studies indicate that this applies to as many as 20%, but the situation in Norway in unknown. Nor is it known why somebody has persistent gastro- intestinal complaints. It may be due to difficulty following the diet or what is called irritable bowel syndrome (IBS), which is a fairly common condition in the population.
It has been shown that people with IBS can benefit from a diet with reduced FODMAP content. The term FODMAP is an acronym for: Fermentable Oligo, Di-, Monosaccharides and Polyols. It is a type of carbohydrate that is not absorbed in the large intestine, but continues to the colon where they are fermented by the bacteria. Example of foods with a high content of FODMAP is wheat, onion, garlic, parsley, apples, pears, mango, beans, honey and milk. It is not known whether celiac patients with persistent symptoms will have the beneficial effect of low FODMAP diet.
In this study, investigators want to study the prevalence of persistent gastrointestinal symptoms and compliance with gluten-free diet and the intake of FODMAP in adult celiac patients. Members of the Norwegian coeliac organization will be invited to participate in the study. A web-based questionnaire is used to make it easy for members to respond.
Participants who report persistent gastrointestinal intestinal symptoms will then be invited to a randomized and controlled study. They will be divided into two groups where one group will be advised to reduce the intake of FODMAP and the other group will be advised to follow a strict gluten-free diet. Participants will record stomach and intestinal complaints before and after four weeks with study sites. Investigators will find out whether there is a difference between gastric and intestinal complaints between the two groups. Blood- and feces samples will also be collected.
The results will provide new knowledge about how to adapt dietary advice to celiac patients with persistent gastrointestinal complaints, and hopefully help them to a better quality of life.
- Being tested
- Low FODMAP diet
- Keywords
- Celiac disease, Irritable bowel syndrome
- Medical subject headings
- Celiac Disease, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low FODMAP dietOther
The intervention group follows the low FODMAP diet for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Low FODMAP diet (LFD) | Active comparator | The LFD wil receive advice on how to follow a low FODMAP diet. They wil follow this diet for 4 weeks. Thereafter they receive advice on how to reintroduce high FODMAPs again. Receives: Other: Low FODMAP diet |
| Control | No intervention | Control group. Participants follow their regular gluten-free diet (GFD), with no changes to their diet. They wil receive the same dietary advice as the LFD-group after the 4-week study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gastrointestinal symptoms
Measured by score in gastrointestinal symptom rating scale for irritable bowel syndrome (GSRS-IBS). The scoring is based on a 7-grade Likert scale in which 1 point indicates no symptoms and 7 points the most severe gastrointestinal symptoms. The total score in the gastrointestinal symptom rating scale for irritable bowel syndrome is calculated as a mean value of all 13 items. The maximum score is 91 and the minimum score is 13. A higher score means more severe symptoms. A score higher than 1 standard deviation (SD, 0.66 points) compared to the control mean are considered to have increased gastrointestinal symptoms.
Measured: 4 weeks
Secondary outcomes (2)
Changes in biomarkers like faecal microbiota
Altered faecal microbiota diversity, measured as a change in diversity and/or abundance or strains from baseline and after 4 weeks on a low FODMAP diet.
Measured: 4 weeks
Quality of Life in patients with coeliac disease: Short form- 36 (SF-36)
Changes in short form-36 (SF-36) as a measure of quality of life. SF-36 covers four physical health perceptions (physical functioning, role limitations because of physical health problems, bodily pain, and general health) and four mental health concepts (vitality, social functioning, role limitations because of personal or emotional problems, and mental health perceptions). Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The range of score is 0 to 100, where a higher score means better quality of life and the lower the score the more disability. A total score for mental health and physical health is calculated as an average of the subscales, with a range from 0 to 100. Here also the higher the score the better quality of life. The standardized combined scores in several populations have a mean of 50 and standard deviation 10. The scoring wil be performed as in the SF-36 scoring manual.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start1 Oct 2018
- Primary completion28 Jul 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group receives advice on following the low-FODMAP diet, and the control group follows their regular gluten free diet.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Knut E. A. Lundin, Oslo University Hospital
- Investigators
- Knut Lundin, Professor, Principal investigator, Oslo University hospital and University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678935
- Sponsor's protocol ID
- 2018/1055
- Status last verified
- Apr 2026
- First submitted
- 17 Sep 2018
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Megen F, Skodje GI, Lergenmuller S, Zuhlke S, Aabakken L, Veierod MB, Henriksen C, Lundin KEA. A Low FODMAP Diet Reduces Symptoms in Treated Celiac Patients With Ongoing Symptoms-A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Oct;20(10):2258-2266.e3. doi: 10.1016/j.cgh.2022.01.011. Epub 2022 Jan 17.
PubMed 35051648van Megen F, Fossli M, Skodje GI, Carlsen MH, Andersen LF, Veierod MB, Lundin KEA, Henriksen C. Nutritional assessment of women with celiac disease compared to the general population. Clin Nutr ESPEN. 2023 Apr;54:251-257. doi: 10.1016/j.clnesp.2023.01.031. Epub 2023 Feb 2.
PubMed 36963870Skodje GI, van Megen F, Stendahl M, Henriksen C, Lundin KEA, Veierod MB. Detection of gluten immunogenic peptides and the Celiac Disease Adherence Test to monitor gluten-free diet: a pilot study. Eur J Clin Nutr. 2022 Jun;76(6):902-903. doi: 10.1038/s41430-021-01054-6. Epub 2022 Jan 10.
PubMed 35001079van Megen F, Skodje GI, Stendahl M, Veierod MB, Lundin KEA, Henriksen C. High disease burden in treated celiac patients - a web-based survey. Scand J Gastroenterol. 2021 Aug;56(8):882-888. doi: 10.1080/00365521.2021.1930146. Epub 2021 May 30.
PubMed 34057009Herfindal AM, van Megen F, Gilde MKO, Valeur J, Rudi K, Skodje GI, Lundin KEA, Henriksen C, Bohn SK. Effects of a low FODMAP diet on gut microbiota in individuals with treated coeliac disease having persistent gastrointestinal symptoms - a randomised controlled trial. Br J Nutr. 2023 Dec 28;130(12):2061-2075. doi: 10.1017/S0007114523001253. Epub 2023 Jun 5.
PubMed 37272479
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fermentable Oligo-, di-, and Monosaccharides and Polyols (FODMAP) Restriction on Persistent GI-symptoms in Coeliac Patients
- ClinicalTrials.gov ID
- NCT03678935
- Acronym / sponsor ID
- 2018/1055
- Keywords
- Celiac disease, Irritable bowel syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 20 Sep 2018 (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.
The first aim of the study is to investigate the prevalence of persistent gastrointestinal symptoms and compliance with gluten-free diet and the intake of FODMAP in adult celiac patients.
A web-based survey wil be performed and thereafter a randomized controlled trial to test the effect of a FODMAP reduction in patients with celiac disease with irritable bowel-like symptoms.
Detailed description
Effect of FODMAP reduction in patients with celiac disease. Celiac disease is an immune-mediated disease that causes damage to the intestines. The condition affects 1-2% of the population, and the incidence is increasing. Treatment with gluten-free diet usually produces good results, yet there are many patients who have persistent gastrointestinal symptoms. Studies indicate that this applies to as many as 20%, but the situation in Norway in unknown. Nor is it known why somebody has persistent gastro- intestinal complaints. It may be due to difficulty following the diet or what is called irritable bowel syndrome (IBS), which is a fairly common condition in the population.
It has been shown that people with IBS can benefit from a diet with reduced FODMAP content. The term FODMAP is an acronym for: Fermentable Oligo, Di-, Monosaccharides and Polyols. It is a type of carbohydrate that is not absorbed in the large intestine, but continues to the colon where they are fermented by the bacteria. Example of foods with a high content of FODMAP is wheat, onion, garlic, parsley, apples, pears, mango, beans, honey and milk. It is not known whether celiac patients with persistent symptoms will have the beneficial effect of low FODMAP diet.
In this study, investigators want to study the prevalence of persistent gastrointestinal symptoms and compliance with gluten-free diet and the intake of FODMAP in adult celiac patients. Members of the Norwegian coeliac organization will be invited to participate in the study. A web-based questionnaire is used to make it easy for members to respond.
Participants who report persistent gastrointestinal intestinal symptoms will then be invited to a randomized and controlled study. They will be divided into two groups where one group will be advised to reduce the intake of FODMAP and the other group will be advised to follow a strict gluten-free diet. Participants will record stomach and intestinal complaints before and after four weeks with study sites. Investigators will find out whether there is a difference between gastric and intestinal complaints between the two groups. Blood- and feces samples will also be collected.
The results will provide new knowledge about how to adapt dietary advice to celiac patients with persistent gastrointestinal complaints, and hopefully help them to a better quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention group receives advice on following the low-FODMAP diet, and the control group follows their regular gluten free diet.
| Arm | Type | Receives |
|---|---|---|
| Low FODMAP diet (LFD) | Active comparator | Other: Low FODMAP dietThe LFD wil receive advice on how to follow a low FODMAP diet. They wil follow this diet for 4 weeks. Thereafter they receive advice on how to reintroduce high FODMAPs again. |
| Control | No intervention | –Control group. Participants follow their regular gluten-free diet (GFD), with no changes to their diet. They wil receive the same dietary advice as the LFD-group after the 4-week study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Coeliac disease
- Adherent to GFD for at least 12 months
- Strictly adherent to GFD
- Normal coeliac disease (CD) serology and duodenal biopsy (Marsh 0-1)
- Persistent GI-symptoms defined by GSRS-IBS score of 30 or more
Key exclusion criteria (7 listed)
- Pregnancy or lactating women
- Use of immunomodulating drugs in the last 3 months
- Use of anti-inflammatory drugs in the last 3 months
- Use of antacid drugs in the last 2 months
- Ongoing infection (mild infection such as upper airway infection is ok)
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 |
|---|---|---|
| Low FODMAP dietThe intervention group follows the low FODMAP diet for 4 weeks. | Other | Low FODMAP diet (LFD) |
Primary outcome
Change in gastrointestinal symptoms
Time frame: 4 weeks
Measured by score in gastrointestinal symptom rating scale for irritable bowel syndrome (GSRS-IBS). The scoring is based on a 7-grade Likert scale in which 1 point indicates no symptoms and 7 points the most severe gastrointestinal symptoms. The total score in the gastrointestinal symptom rating scale for irritable bowel syndrome is calculated as a mean value of all 13 items. The maximum score is 91 and the minimum score is 13. A higher score means more severe symptoms. A score higher than 1 standard deviation (SD, 0.66 points) compared to the control mean are considered to have increased gastrointestinal symptoms.
2 secondary outcomes
Changes in biomarkers like faecal microbiota
Time frame: 4 weeks
Quality of Life in patients with coeliac disease: Short form- 36 (SF-36)
Time frame: 4 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 17 Apr 2026.
- Results publication: PubMed 35051648van Megen F, Skodje GI, Lergenmuller S, Zuhlke S, Aabakken L, Veierod MB, Henriksen C, Lundin KEA. A Low FODMAP Diet Reduces Symptoms in Treated Celiac Patients With Ongoing Symptoms-A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Oct;20(10):2258-2266.e3. doi: 10.1016/j.cgh.2022.01.011. Epub 2022 Jan 17.
- Results publication: PubMed 36963870van Megen F, Fossli M, Skodje GI, Carlsen MH, Andersen LF, Veierod MB, Lundin KEA, Henriksen C. Nutritional assessment of women with celiac disease compared to the general population. Clin Nutr ESPEN. 2023 Apr;54:251-257. doi: 10.1016/j.clnesp.2023.01.031. Epub 2023 Feb 2.
- Results publication: PubMed 35001079Skodje GI, van Megen F, Stendahl M, Henriksen C, Lundin KEA, Veierod MB. Detection of gluten immunogenic peptides and the Celiac Disease Adherence Test to monitor gluten-free diet: a pilot study. Eur J Clin Nutr. 2022 Jun;76(6):902-903. doi: 10.1038/s41430-021-01054-6. Epub 2022 Jan 10.
- Results publication: PubMed 34057009van Megen F, Skodje GI, Stendahl M, Veierod MB, Lundin KEA, Henriksen C. High disease burden in treated celiac patients - a web-based survey. Scand J Gastroenterol. 2021 Aug;56(8):882-888. doi: 10.1080/00365521.2021.1930146. Epub 2021 May 30.
- Results publication: PubMed 37272479Herfindal AM, van Megen F, Gilde MKO, Valeur J, Rudi K, Skodje GI, Lundin KEA, Henriksen C, Bohn SK. Effects of a low FODMAP diet on gut microbiota in individuals with treated coeliac disease having persistent gastrointestinal symptoms - a randomised controlled trial. Br J Nutr. 2023 Dec 28;130(12):2061-2075. doi: 10.1017/S0007114523001253. Epub 2023 Jun 5.
- 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.
Knut Lundin, Professor principal investigator
Oslo University hospital and University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low FODMAP diet in people with Celiac Disease and Irritable Bowel Syndrome, run by Oslo University Hospital at 1 site in Norway.
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 6 inclusion and 7 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 17 Apr 2026. 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 Norway. 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?
Change in gastrointestinal symptoms (time frame: 4 weeks). 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 NCT03678935, which also lists 5 linked publications.
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 17 Apr 2026.