Irritable Bowel SyndromeKRIBSNCT02107625
Traditional Dietary Advice Versus a Low FODMAP Diet Intake in IBS Patients
A study testing Diet A i.e. Low FODMAP diet and Diet B, i.e. Traditional IBS diet in people with Irritable Bowel Syndrome, run by Göteborg University.
Trial summary
The purpose of this study is to to assess if the new diet with a low-FODMAP(Fermented Oligo-, Di-, Monosaccharides And Polyols) -content yields a milder symptom picture in IBS patients compared to traditionally dietary advice in IBS. The study also aim to investigate patients compliance to either dietary advices. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Diet A i.e. Low FODMAP diet and Diet B, i.e. Traditional IBS diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Jan 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IBS diagnosis
- Adult (over 18 years)
- Be able to read/understand/write swedish
Who cannot join
- Severe heart failure
- Severe liver disease
- Severe neurologic disease
- Severe psychological disease
- Severe gastrointestinal disease (i.e. celiac disease, IBD (inflammatory bowel disease) e.g.)
About this study
Official title: A Multi-centre, Randomized, Single-blind, Comparative Trial: Traditional Dietary Advice Versus a Low FODMAP Diet Intake in IBS Patients
The purpose of this study is to to assess if the new diet with a low-FODMAP(Fermented Oligo-, Di-, Monosaccharides And Polyols) -content yields a milder symptom picture in IBS patients compared to traditionally dietary advice in IBS. The study also aim to investigate patients compliance to either dietary advices. Further, the investigators aim to find out if IBS patients with different symptoms are alleviated in different ways, to be able to individualize the dietary advices to result in a more optimal symptom relief in each patient in the future.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Diet A i.e. Low FODMAP diet, Diet B, i.e. Traditional IBS diet
- Keywords
- Defecation, Abdominal pain
- Medical subject headings
- Irritable Bowel Syndrome, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet A i.e. Low FODMAP dietBehavioural
Diet B, i.e. Traditional IBS dietBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Diet A i.e. Low FODMAP diet | Experimental | The patients are thoroughly informed verbally and in writing how to eat according to the low FODMAP diet. The diet imply restrictions in carbohydrate intake and the patients need to follow a list with yes/no-foods for 4 weeks. Receives: Behavioral: Diet A i.e. Low FODMAP diet |
| Diet B, i.e. Traditional IBS diet | Experimental | The patients are thoroughly informed verbally and in writing how to eat according to traditional IBS dietary advices. The diet imply adapting to regular dietary habit with meals 6 times a day, no to big meals, to chew food thoroughly, to peel fruits and vegetables, no carbonated beverages, no chewing gum, no soft drinks, no sugar-free candies, or cookies. Reduce spicy foods, coffee, alcohol, onion, pulses, and fatty foods. Keep strictly to the dietary advice for 4 weeks. Receives: Behavioral: Diet B, i.e. Traditional IBS diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom alleviation through the questionnaire IBS-SSS
IBS-SSS i.e. the IBS Severity Scoring System. To assess the possible change of severity of IBS symptoms. The overall IBS score is calculated ranging from 0 to 500. A higher score implicates more severe symptom.
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 posted8 Apr 2014 (estimated)
- Study startAug 2013
- Primary completionJan 2015
- Study completionJan 2015
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 Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Aleris Specialistvård Sabbatsberg
- Responsible party
- Principal investigator, Hans Törnblom, Sahlgrenska University Hospital
- Investigators
- Hans Törnblom, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107625
- Sponsor's protocol ID
- KRIBS1
- Acronym
- KRIBS
- Status last verified
- Aug 2015
- First submitted
- 4 Apr 2014
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Nybacka S, Colomier E, Pall Hreinsson J, Storsrud S, Tack J, Tornblom H, Simren M. Dietary Intake and Quality in Irritable Bowel Syndrome: A Comparative Study With Controls and the Association With Symptom Severity. Am J Gastroenterol. 2024 Nov 27;120(9):2154-2164. doi: 10.14309/ajg.0000000000003249.
PubMed 39601420Nybacka S, Simren M, Storsrud S, Tornblom H, Winkvist A, Lindqvist HM. Changes in serum and urinary metabolomic profile after a dietary intervention in patients with irritable bowel syndrome. PLoS One. 2021 Oct 11;16(10):e0257331. doi: 10.1371/journal.pone.0257331. eCollection 2021.
PubMed 34634050Nybacka S, Storsrud S, Liljebo T, Le Neve B, Tornblom H, Simren M, Winkvist A. Within- and Between-Subject Variation in Dietary Intake of Fermentable Oligo-, Di-, Monosaccharides, and Polyols Among Patients with Irritable Bowel Syndrome. Curr Dev Nutr. 2018 Dec 24;3(2):nzy101. doi: 10.1093/cdn/nzy101. eCollection 2019 Feb.
PubMed 30838348Bennet SMP, Bohn L, Storsrud S, Liljebo T, Collin L, Lindfors P, Tornblom H, Ohman L, Simren M. Multivariate modelling of faecal bacterial profiles of patients with IBS predicts responsiveness to a diet low in FODMAPs. Gut. 2018 May;67(5):872-881. doi: 10.1136/gutjnl-2016-313128. Epub 2017 Apr 17.
PubMed 28416515Bohn L, Storsrud S, Liljebo T, Collin L, Lindfors P, Tornblom H, Simren M. Diet low in FODMAPs reduces symptoms of irritable bowel syndrome as well as traditional dietary advice: a randomized controlled trial. Gastroenterology. 2015 Nov;149(6):1399-1407.e2. doi: 10.1053/j.gastro.2015.07.054. Epub 2015 Aug 5.
PubMed 26255043
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomized, Single-blind, Comparative Trial: Traditional Dietary Advice Versus a Low FODMAP Diet Intake in IBS Patients
- ClinicalTrials.gov ID
- NCT02107625
- Acronym / sponsor ID
- KRIBS / KRIBS1
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Defecation, Abdominal pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Aleris Specialistvård Sabbatsberg
- Study start
- Aug 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 8 Apr 2014 (estimated)
- 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 purpose of this study is to to assess if the new diet with a low-FODMAP(Fermented Oligo-, Di-, Monosaccharides And Polyols) -content yields a milder symptom picture in IBS patients compared to traditionally dietary advice in IBS. The study also aim to investigate patients compliance to either dietary advices. Further, the investigators aim to find out if IBS patients with different symptoms are alleviated in different ways, to be able to individualize the dietary advices to result in a more optimal symptom relief in each patient in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet A i.e. Low FODMAP diet | Experimental | Behavioral: Diet A i.e. Low FODMAP dietThe patients are thoroughly informed verbally and in writing how to eat according to the low FODMAP diet. The diet imply restrictions in carbohydrate intake and the patients need to follow a list with yes/no-foods for 4 weeks. |
| Diet B, i.e. Traditional IBS diet | Experimental | Behavioral: Diet B, i.e. Traditional IBS dietThe patients are thoroughly informed verbally and in writing how to eat according to traditional IBS dietary advices. The diet imply adapting to regular dietary habit with meals 6 times a day, no to big meals, to chew food thoroughly, to peel fruits and vegetables, no carbonated beverages, no chewing gum, no soft drinks, no sugar-free candies, or cookies. Reduce spicy foods, coffee, alcohol, onion, pulses, and fatty foods. Keep strictly to the dietary advice for 4 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- IBS diagnosis
- Adult (over 18 years)
- Be able to read/understand/write swedish
Key exclusion criteria (5 listed)
- Severe heart failure
- Severe liver disease
- Severe neurologic disease
- Severe psychological disease
- Severe gastrointestinal disease (i.e. celiac disease, IBD (inflammatory bowel disease) e.g.)
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 |
|---|---|---|
| Diet A i.e. Low FODMAP diet | Behavioural | Diet A i.e. Low FODMAP diet |
| Diet B, i.e. Traditional IBS diet | Behavioural | Diet B, i.e. Traditional IBS diet |
Primary outcome
Symptom alleviation through the questionnaire IBS-SSS
Time frame: 4 weeks
IBS-SSS i.e. the IBS Severity Scoring System. To assess the possible change of severity of IBS symptoms. The overall IBS score is calculated ranging from 0 to 500. A higher score implicates more severe symptom.
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 20 Aug 2015.
- Derived from this study: PubMed 39601420Nybacka S, Colomier E, Pall Hreinsson J, Storsrud S, Tack J, Tornblom H, Simren M. Dietary Intake and Quality in Irritable Bowel Syndrome: A Comparative Study With Controls and the Association With Symptom Severity. Am J Gastroenterol. 2024 Nov 27;120(9):2154-2164. doi: 10.14309/ajg.0000000000003249.
- Derived from this study: PubMed 34634050Nybacka S, Simren M, Storsrud S, Tornblom H, Winkvist A, Lindqvist HM. Changes in serum and urinary metabolomic profile after a dietary intervention in patients with irritable bowel syndrome. PLoS One. 2021 Oct 11;16(10):e0257331. doi: 10.1371/journal.pone.0257331. eCollection 2021.
- Derived from this study: PubMed 30838348Nybacka S, Storsrud S, Liljebo T, Le Neve B, Tornblom H, Simren M, Winkvist A. Within- and Between-Subject Variation in Dietary Intake of Fermentable Oligo-, Di-, Monosaccharides, and Polyols Among Patients with Irritable Bowel Syndrome. Curr Dev Nutr. 2018 Dec 24;3(2):nzy101. doi: 10.1093/cdn/nzy101. eCollection 2019 Feb.
- Derived from this study: PubMed 28416515Bennet SMP, Bohn L, Storsrud S, Liljebo T, Collin L, Lindfors P, Tornblom H, Ohman L, Simren M. Multivariate modelling of faecal bacterial profiles of patients with IBS predicts responsiveness to a diet low in FODMAPs. Gut. 2018 May;67(5):872-881. doi: 10.1136/gutjnl-2016-313128. Epub 2017 Apr 17.
- Derived from this study: PubMed 26255043Bohn L, Storsrud S, Liljebo T, Collin L, Lindfors P, Tornblom H, Simren M. Diet low in FODMAPs reduces symptoms of irritable bowel syndrome as well as traditional dietary advice: a randomized controlled trial. Gastroenterology. 2015 Nov;149(6):1399-1407.e2. doi: 10.1053/j.gastro.2015.07.054. Epub 2015 Aug 5.
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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.
Hans Törnblom, MD, PhD principal investigator
Sahlgrenska University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Diet A i.e. Low FODMAP diet and Diet B, i.e. Traditional IBS diet in people with Irritable Bowel Syndrome, run by Göteborg University.
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 3 inclusion and 5 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 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Symptom alleviation through the questionnaire IBS-SSS (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 NCT02107625, 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 20 Aug 2015.