Irritable Bowel SyndromeCARIBSNCT02970591
A Comparison of Three Different Treatment Options for Irritable Bowel Syndrome
A study testing Traditional dietary advice and low FODMAP content, Low carbohydrate diet and Optimized Medical treatment in people with Irritable Bowel Syndrome, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Irritable Bowel Syndrome is a common disease to which there is no curable treatment. Diet is considered to trigger symptoms associated with the clinical picture of IBS, and dietary treatment is thus believed to relieve the symptoms of IBS. 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?
- Traditional dietary advice and low FODMAP content, Low carbohydrate diet and Optimized Medical treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2017to 29 Apr 2022
- 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 according to ROME IV criteria, BMI 18-35, ability to communicate in Swedish, Gothenburg region resident
Who cannot join
- Heart, liver, neurologic or psychiatric disease or illness
- Serious gastrointestinal diseases
- Celiac disease
- Diabetes
- Other conditions or surgery that affects the gastrointestinal function
- Hyperlipidemia
Show all 10Show fewer
- Food allergy or intolerance other than lactose
- Adherence to a specific diet
- Being pregnant or breastfeeding
- Previously been treated with any of the intervention arms, including having tested all of the pharmacological treatment options of relevance for the symptom profile of the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of CARbohydrates in Irritable Bowel Syndrome (CARIBS): Protocol for a Randomized Controlled Trial Comparing Three Different Treatment Options
Irritable Bowel Syndrome is a common disease to which there is no curable treatment. Diet is considered to trigger symptoms associated with the clinical picture of IBS, and dietary treatment is thus believed to relieve the symptoms of IBS. As the disease is very heterogeneous in its manifestation, different treatment options might be indicated depending on the predominant symptom. To investigate the response to different dietary treatment options, a randomized controlled intervention trial will be carried out in adult patients (>18 y) with IBS according to Rome IV criteria. The aim of this study is to compare the response to two different dietary treatments or optimized medical treatment.
Read the detailed description
The study is a randomized controlled trial comparing three different treatments during four weeks:
- Combination of low FODMAP diet + traditional dietary advice (based on NICE recommendations)
- Eat at regular hours; 3 main meals and 3 snacks
- Eat in peace, chew the food properly
- Peel all fruits and vegetables
- Limit intake of spicy and fatty foods, coffe, alcohol, avoid fizzy drinks and chewing gum
- Choose soluble rather than insoluble fibres
- Avoid foods high in FODMAPs
- Diet low in carbohydrates
- 10 E% carbohydrates, 23 E% protein, 67 E% fat
- Larger amounts of fish, shellfish, meat, egg, dairy products (lactose free if wanted) nuts, seeds, oil, vegetables
- No sugary or starchy foods, e.g pasta, potatoes, bread, rice, most fruits
- No specific consideration about FODMAP content
- Optimized pharmacological tretament based on predominant symptom and previous experience with pharmacological treatmment.
Pain/discomfort:
- Pain: Amitriptyline 25 mg. Increase to 50 mg if needed
- Episodic pain: Hyoscyamine 0,2mg 2x2; adjust dose if needed
- Pain with diarrhea: Amitriptyline 25 mg. Increase dose if needed
- Pain with constipation: Linaclotide 290 microgram 1x1
Constipation:
- Bulking agent (Sterculia gum (Inolaxol) 1x1. Increase to 1x3 if needed
- Osmotic laxative (Macrogol (Movicol) 1x1
- Linaclotide 290 microgram 1x1 Diarrhea
- Loperamide 1x2 . Adjust dose if needed
- Cholestyramine 1x1. Increase ever 3-5 d as needed
- Ondansetron 4mg 1x1. Increase to 1x2-3 if needed
- Eluxadoline 100mg 1x2
Primary endpoint: IBS-SSS reduction >50 points
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Traditional dietary advice and low FODMAP content, Low carbohydrate diet, Optimized Medical treatment
- Keywords
- FODMAPS, carbohydrates, metabolomics, microbiota
- 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.
Traditional dietary advice and low FODMAP contentOther
Traditional dietary advice according to the Brittish Dietetic Association including reducing the intake of fermentable carbohydrates.
Low carbohydrate dietOther
Diet that contains a maximum of 10 energy percent of carbohydrates, 23 energy % proteins and 67 energy % fat.
Optimized Medical treatmentOther
Standard consultation by physician and if needed patients will receive medical treatment based on the most prominent symptom. Constipation: osmotic laxatives, linaclotide. Diarrhea: loperamid, bile acid binders. Pain: anti depressent, antispasmodics, linaclotide.
| Study group | Role | What they receive |
|---|---|---|
| Diet A | Experimental | Low carbohydrate diet Receives: Other: Traditional dietary advice and low FODMAP content |
| Medical treatment | Active comparator | Optimized Medical treatment Receives: Other: Optimized Medical treatment |
| Diet B | Experimental | Traditional dietary advice and low FODMAP content Receives: Other: Low carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion (%) of patients who respond to treatment
A responder is defined as having an IBS-SSS reduction >50 points @ 4 weeks
Measured: Baseline to 4 weeks
Secondary outcomes (8)
Change in symptom severity
Absolute and percentage change in IBS-SSS
Measured: Baseline, 4 weeks, 3 and 6 months
Determinants for GI symptoms by IBS-SSS
GI symptoms measured by IBS-SSS
Measured: Baseline, 4 weeks, 3 and 6 months
Determinants for GI symptoms by GSRS-IBS
GI symptoms measured by GSRS-IBS
Measured: Baseline, 4 weeks, 3 and 6 months
Predictors of response to treatment
Potential predictors include demographics, questionnaire data, microbiota, metabolites, immunology
Measured: Baseline to 4 weeks
Adherence to allocated intervention
Including compliance to dietary intervention during 4 weeks, and long-term adherence during follow-up
Measured: Baseline, 4 weeks, 3 and 6 months
Change in microbiota content
Fecal microbiota analysis using 16S technique
Measured: Baseline, 4 weeks, 6 months
Change in extra-intestinal symptoms and quality of life
As assessed by IBS specific questionnaires
Measured: Baseline, 4 weeks, 3 and 6 months
Change in metabolic profile
Metabolomics in serum and urine samples
Measured: Baseline, 4 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startJan 2017
- Primary completion15 Apr 2022
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Sahlgrenska 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magnus Simrén, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970591
- Sponsor's protocol ID
- Car-IBS 1511-01
- Acronym
- CARIBS
- Status last verified
- Oct 2022
- First submitted
- 18 Nov 2016
- Last updated
- 27 Oct 2022
- Results posted
- No
- Individual data sharing
- No
Publications
Nybacka S, Tornblom H, Josefsson A, Hreinsson JP, Bohn L, Frandemark A, Weznaver C, Storsrud S, Simren M. A low FODMAP diet plus traditional dietary advice versus a low-carbohydrate diet versus pharmacological treatment in irritable bowel syndrome (CARIBS): a single-centre, single-blind, randomised controlled trial. Lancet Gastroenterol Hepatol. 2024 Jun;9(6):507-520. doi: 10.1016/S2468-1253(24)00045-1. Epub 2024 Apr 18.
PubMed 38643782Nybacka S, Tornblom H, Simren M, Storsrud S. The Role of Carbohydrates in Irritable Bowel Syndrome: Protocol for a Randomized Controlled Trial Comparing Three Different Treatment Options. JMIR Res Protoc. 2022 Jan 17;11(1):e31413. doi: 10.2196/31413.
PubMed 35037893Algera JP, Storsrud S, Lindstrom A, Simren M, Tornblom H. Gluten and fructan intake and their associations with gastrointestinal symptoms in irritable bowel syndrome: A food diary study. Clin Nutr. 2021 Oct;40(10):5365-5372. doi: 10.1016/j.clnu.2021.09.002. Epub 2021 Sep 9.
PubMed 34560607
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of CARbohydrates in Irritable Bowel Syndrome (CARIBS): Protocol for a Randomized Controlled Trial Comparing Three Different Treatment Options
- ClinicalTrials.gov ID
- NCT02970591
- Acronym / sponsor ID
- CARIBS / Car-IBS 1511-01
- Conditions
- Irritable Bowel Syndrome
- Keywords
- FODMAPS, carbohydrates, metabolomics, microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 22 Nov 2016 (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.
Irritable Bowel Syndrome is a common disease to which there is no curable treatment. Diet is considered to trigger symptoms associated with the clinical picture of IBS, and dietary treatment is thus believed to relieve the symptoms of IBS. As the disease is very heterogeneous in its manifestation, different treatment options might be indicated depending on the predominant symptom. To investigate the response to different dietary treatment options, a randomized controlled intervention trial will be carried out in adult patients (>18 y) with IBS according to Rome IV criteria. The aim of this study is to compare the response to two different dietary treatments or optimized medical treatment.
Detailed description
The study is a randomized controlled trial comparing three different treatments during four weeks:
- Combination of low FODMAP diet + traditional dietary advice (based on NICE recommendations)
- Eat at regular hours; 3 main meals and 3 snacks
- Eat in peace, chew the food properly
- Peel all fruits and vegetables
- Limit intake of spicy and fatty foods, coffe, alcohol, avoid fizzy drinks and chewing gum
- Choose soluble rather than insoluble fibres
- Avoid foods high in FODMAPs
- Diet low in carbohydrates
- 10 E% carbohydrates, 23 E% protein, 67 E% fat
- Larger amounts of fish, shellfish, meat, egg, dairy products (lactose free if wanted) nuts, seeds, oil, vegetables
- No sugary or starchy foods, e.g pasta, potatoes, bread, rice, most fruits
- No specific consideration about FODMAP content
- Optimized pharmacological tretament based on predominant symptom and previous experience with pharmacological treatmment.
Pain/discomfort:
- Pain: Amitriptyline 25 mg. Increase to 50 mg if needed
- Episodic pain: Hyoscyamine 0,2mg 2x2; adjust dose if needed
- Pain with diarrhea: Amitriptyline 25 mg. Increase dose if needed
- Pain with constipation: Linaclotide 290 microgram 1x1
Constipation:
- Bulking agent (Sterculia gum (Inolaxol) 1x1. Increase to 1x3 if needed
- Osmotic laxative (Macrogol (Movicol) 1x1
- Linaclotide 290 microgram 1x1 Diarrhea
- Loperamide 1x2 . Adjust dose if needed
- Cholestyramine 1x1. Increase ever 3-5 d as needed
- Ondansetron 4mg 1x1. Increase to 1x2-3 if needed
- Eluxadoline 100mg 1x2
Primary endpoint: IBS-SSS reduction >50 points
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diet A | Experimental | Other: Traditional dietary advice and low FODMAP contentLow carbohydrate diet |
| Medical treatment | Active comparator | Other: Optimized Medical treatmentOptimized Medical treatment |
| Diet B | Experimental | Other: Low carbohydrate dietTraditional dietary advice and low FODMAP content |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- IBS according to ROME IV criteria, BMI 18-35, ability to communicate in Swedish, Gothenburg region resident
Key exclusion criteria (10 listed)
- Heart, liver, neurologic or psychiatric disease or illness
- Serious gastrointestinal diseases
- Celiac disease
- Diabetes
- Other conditions or surgery that affects the gastrointestinal function
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 |
|---|---|---|
| Traditional dietary advice and low FODMAP contentTraditional dietary advice according to the Brittish Dietetic Association including reducing the intake of fermentable carbohydrates. | Other | Diet A |
| Low carbohydrate dietDiet that contains a maximum of 10 energy percent of carbohydrates, 23 energy % proteins and 67 energy % fat. | Other | Diet B |
| Optimized Medical treatmentStandard consultation by physician and if needed patients will receive medical treatment based on the most prominent symptom. Constipation: osmotic laxatives, linaclotide. Diarrhea: loperamid, bile acid binders. Pain: anti depressent, antispasmodics, linaclotide. | Other | Medical treatment |
Primary outcome
The proportion (%) of patients who respond to treatment
Time frame: Baseline to 4 weeks
A responder is defined as having an IBS-SSS reduction >50 points @ 4 weeks
8 secondary outcomes
Change in symptom severity
Time frame: Baseline, 4 weeks, 3 and 6 months
Determinants for GI symptoms by IBS-SSS
Time frame: Baseline, 4 weeks, 3 and 6 months
Determinants for GI symptoms by GSRS-IBS
Time frame: Baseline, 4 weeks, 3 and 6 months
Predictors of response to treatment
Time frame: Baseline to 4 weeks
Adherence to allocated intervention
Time frame: Baseline, 4 weeks, 3 and 6 months
Change in microbiota content
Time frame: Baseline, 4 weeks, 6 months
Change in extra-intestinal symptoms and quality of life
Time frame: Baseline, 4 weeks, 3 and 6 months
Change in metabolic profile
Time frame: Baseline, 4 weeks, 6 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 27 Oct 2022.
- Derived from this study: PubMed 38643782Nybacka S, Tornblom H, Josefsson A, Hreinsson JP, Bohn L, Frandemark A, Weznaver C, Storsrud S, Simren M. A low FODMAP diet plus traditional dietary advice versus a low-carbohydrate diet versus pharmacological treatment in irritable bowel syndrome (CARIBS): a single-centre, single-blind, randomised controlled trial. Lancet Gastroenterol Hepatol. 2024 Jun;9(6):507-520. doi: 10.1016/S2468-1253(24)00045-1. Epub 2024 Apr 18.
- Derived from this study: PubMed 35037893Nybacka S, Tornblom H, Simren M, Storsrud S. The Role of Carbohydrates in Irritable Bowel Syndrome: Protocol for a Randomized Controlled Trial Comparing Three Different Treatment Options. JMIR Res Protoc. 2022 Jan 17;11(1):e31413. doi: 10.2196/31413.
- Derived from this study: PubMed 34560607Algera JP, Storsrud S, Lindstrom A, Simren M, Tornblom H. Gluten and fructan intake and their associations with gastrointestinal symptoms in irritable bowel syndrome: A food diary study. Clin Nutr. 2021 Oct;40(10):5365-5372. doi: 10.1016/j.clnu.2021.09.002. Epub 2021 Sep 9.
- 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 Traditional dietary advice and low FODMAP content, Low carbohydrate diet and Optimized Medical treatment in people with Irritable Bowel Syndrome, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 1 inclusion and 10 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 27 Oct 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 Sweden. 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?
The proportion (%) of patients who respond to treatment (time frame: Baseline to 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 NCT02970591, which also lists 3 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 27 Oct 2022.