Irritable Bowel SyndromeNCT05618106
Low FODMAP Diet in Patients With IBS
A study testing Low FODMAP DIET = Diet with Low polyol, FOS and GOS in people with Irritable Bowel Syndrome, run by Jens Rikardt Andersen at 1 site in Denmark.
Trial summary
The aim was aimed to investigate if all carbohydrate groups eliminated in the Low FODMAP diet are equally important in relieving gastrointestinal symptoms in IBS. in a randomized cross-over design to three different carbohydrate-modified diets: A) Low Polyol diet, B) Low FOS+GOS diet, and C) Low FODMAP diet for three… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Low FODMAP DIET = Diet with Low polyol, FOS and GOS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2019to 1 Feb 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IBS diagnosed by the Rome III criteria and
- referred to the clinic for treatment by diet
Who cannot join
- Dementia
- lack of ability to speak Danish
- additional chronic diseases prevailing participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modification of the Low FODMAP Diet in Treatment of Irritable Bowel Syndrome: A Randomised Cross-over Study
The aim was aimed to investigate if all carbohydrate groups eliminated in the Low FODMAP diet are equally important in relieving gastrointestinal symptoms in IBS.
in a randomized cross-over design to three different carbohydrate-modified diets: A) Low Polyol diet, B) Low FOS+GOS diet, and C) Low FODMAP diet for three months without wash-out-periods. Gastrointestinal symptoms, Quality of life was measured at baseline and after each intervention diet.
Read the detailed description
Low FODMAP diets contain 3 major types of carbohydrates to be avoided. The clasical diet is very difficult to maintain over longer periods of time. Therefore, we aimed to investigate if all carbohydrate groups in the Low FODMAP diet are equally important in relieving gastrointestinal symptoms in IBS.
Patients diagnosed with IBS according to the Rome III criteria were randomised in a cross-over design to three different carbohydrate-modified diets: A) Low Polyol diet, B) Low FOS+GOS diet, and C) Low FODMAP diet for a total of three months without wash-out-periods. Gastrointestinal symptoms were assessed by the Birmingham IBS questionnaire and adequate relief (IBS-AR). Quality of life was measured by the IBS Quality of Life Scale questionnaire (IBS-QOL). All registrations were performed at baseline and after each intervention diet.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Low FODMAP DIET = Diet with Low polyol, FOS and GOS
- Keywords
- Carbohydrates, low FODMAP diet, components in the low FODMAP diet
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low FODMAP DIET = Diet with Low polyol, FOS and GOSOther
Low Polyol diet
| Study group | Role | What they receive |
|---|---|---|
| low FODMAP diet | Experimental | Diet low in all kinds of FODMAPS Receives: Other: Low FODMAP DIET = Diet with Low polyol, FOS and GOS |
| Low Fodmap diet but polyols allowed | Placebo comparator | Diet low in FOS and GOS Receives: Other: Low FODMAP DIET = Diet with Low polyol, FOS and GOS |
| Low Fodmap diet but FOS and GOS allowed | Active comparator | Diet low in polyols Receives: Other: Low FODMAP DIET = Diet with Low polyol, FOS and GOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birmingham IBS questionnaire and adequate relief (IBS-AR).
Score in points (low score means few symptoms)
Measured: 3 months
Secondary outcomes (1)
IBS Quality of Life Scale questionnaire (IBS-QOL)
Score in points (high score means better life satisfaction)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start1 Mar 2019
- Primary completion1 Oct 2019
- Study completion1 Feb 2020
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 Irritable Bowel SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cross-over of 3 variations of the low FODMAP diet excluding 1 of the 3 components in every period
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jens Rikardt Andersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- Jens R Andersen, MD, MPA, Study chair, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618106
- Sponsor's protocol ID
- FODMAP
- Status last verified
- Mar 2025
- First submitted
- 8 Nov 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jensen LG, Kjaer M, Andersen JR. Modification of the Low FODMAP Diet Is Feasible in the Treatment of Irritable Bowel Syndrome: A Randomised Crossover Study. Gastroenterol Res Pract. 2025 Nov 13;2025:4152978. doi: 10.1155/grp/4152978. eCollection 2025.
PubMed 41278484
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of the Low FODMAP Diet in Treatment of Irritable Bowel Syndrome: A Randomised Cross-over Study
- ClinicalTrials.gov ID
- NCT05618106
- Acronym / sponsor ID
- FODMAP
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Carbohydrates, low FODMAP diet, components in the low FODMAP diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Jens Rikardt AndersenUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 16 Nov 2022 (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 aim was aimed to investigate if all carbohydrate groups eliminated in the Low FODMAP diet are equally important in relieving gastrointestinal symptoms in IBS.
in a randomized cross-over design to three different carbohydrate-modified diets: A) Low Polyol diet, B) Low FOS+GOS diet, and C) Low FODMAP diet for three months without wash-out-periods. Gastrointestinal symptoms, Quality of life was measured at baseline and after each intervention diet.
Detailed description
Low FODMAP diets contain 3 major types of carbohydrates to be avoided. The clasical diet is very difficult to maintain over longer periods of time. Therefore, we aimed to investigate if all carbohydrate groups in the Low FODMAP diet are equally important in relieving gastrointestinal symptoms in IBS.
Patients diagnosed with IBS according to the Rome III criteria were randomised in a cross-over design to three different carbohydrate-modified diets: A) Low Polyol diet, B) Low FOS+GOS diet, and C) Low FODMAP diet for a total of three months without wash-out-periods. Gastrointestinal symptoms were assessed by the Birmingham IBS questionnaire and adequate relief (IBS-AR). Quality of life was measured by the IBS Quality of Life Scale questionnaire (IBS-QOL). All registrations were performed at baseline and after each intervention diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Cross-over of 3 variations of the low FODMAP diet excluding 1 of the 3 components in every period
| Arm | Type | Receives |
|---|---|---|
| low FODMAP diet | Experimental | Other: Low FODMAP DIET = Diet with Low polyol, FOS and GOSDiet low in all kinds of FODMAPS |
| Low Fodmap diet but polyols allowed | Placebo comparator | Other: Low FODMAP DIET = Diet with Low polyol, FOS and GOSDiet low in FOS and GOS |
| Low Fodmap diet but FOS and GOS allowed | Active comparator | Other: Low FODMAP DIET = Diet with Low polyol, FOS and GOSDiet low in polyols |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- IBS diagnosed by the Rome III criteria and
- referred to the clinic for treatment by diet
Key exclusion criteria (3 listed)
- Dementia
- lack of ability to speak Danish
- additional chronic diseases prevailing participation
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 DIET = Diet with Low polyol, FOS and GOSLow Polyol diet | Other | Low Fodmap diet but FOS and GOS allowed, Low Fodmap diet but polyols allowed, low FODMAP diet |
Primary outcome
Birmingham IBS questionnaire and adequate relief (IBS-AR).
Time frame: 3 months
Score in points (low score means few symptoms)
1 secondary outcome
IBS Quality of Life Scale questionnaire (IBS-QOL)
Time frame: 3 months
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 2 Apr 2025.
- Derived from this study: PubMed 41278484Jensen LG, Kjaer M, Andersen JR. Modification of the Low FODMAP Diet Is Feasible in the Treatment of Irritable Bowel Syndrome: A Randomised Crossover Study. Gastroenterol Res Pract. 2025 Nov 13;2025:4152978. doi: 10.1155/grp/4152978. eCollection 2025.
- 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.
Jens R Andersen, MD, MPA study chair
University of Copenhagen
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 = Diet with Low polyol, FOS and GOS in people with Irritable Bowel Syndrome, run by Jens Rikardt Andersen at 1 site in Denmark.
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 3 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 2 Apr 2025. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Birmingham IBS questionnaire and adequate relief (IBS-AR). (time frame: 3 months). 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 NCT05618106, 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 2 Apr 2025.