A Comparison of Three Different Treatment Options for Irritable Bowel Syndrome (CARIBS)

October 24, 2022 updated by: Magnus Simrén, Sahlgrenska University Hospital, Sweden

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is a randomized controlled trial comparing three different treatments during four weeks:

  1. 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

  2. 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
  3. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Non-US/Non-Canadian
      • Gothenburg, Non-US/Non-Canadian, Sweden, 44331
        • Magnus Simrén

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • IBS according to ROME IV criteria, BMI 18-35, ability to communicate in Swedish, Gothenburg region resident

Exclusion Criteria:

  • Heart, liver, neurologic or psychiatric disease or illness
  • Serious gastrointestinal diseases
  • Celiac disease
  • Diabetes
  • Other conditions or surgery that affects the gastrointestinal function
  • Hyperlipidemia
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Diet A
Low carbohydrate diet
Other: Traditional dietary advice and low FODMAP content
Traditional dietary advice according to the Brittish Dietetic Association including reducing the intake of fermentable carbohydrates.
Active Comparator: Medical treatment
Optimized Medical treatment
Other: Optimized Medical treatment
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.
Experimental: Diet B
Traditional dietary advice and low FODMAP content
Other: Low carbohydrate diet
Diet that contains a maximum of 10 energy percent of carbohydrates, 23 energy % proteins and 67 energy % fat.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline to 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in symptom severity
Time Frame: Baseline, 4 weeks, 3 and 6 months
Absolute and percentage change in IBS-SSS
Baseline, 4 weeks, 3 and 6 months
Determinants for GI symptoms by IBS-SSS
Time Frame: Baseline, 4 weeks, 3 and 6 months
GI symptoms measured by IBS-SSS
Baseline, 4 weeks, 3 and 6 months
Determinants for GI symptoms by GSRS-IBS
Time Frame: Baseline, 4 weeks, 3 and 6 months
GI symptoms measured by GSRS-IBS
Baseline, 4 weeks, 3 and 6 months
Predictors of response to treatment
Time Frame: Baseline to 4 weeks
Potential predictors include demographics, questionnaire data, microbiota, metabolites, immunology
Baseline to 4 weeks
Adherence to allocated intervention
Time Frame: Baseline, 4 weeks, 3 and 6 months
Including compliance to dietary intervention during 4 weeks, and long-term adherence during follow-up
Baseline, 4 weeks, 3 and 6 months
Change in microbiota content
Time Frame: Baseline, 4 weeks, 6 months
Fecal microbiota analysis using 16S technique
Baseline, 4 weeks, 6 months
Change in extra-intestinal symptoms and quality of life
Time Frame: Baseline, 4 weeks, 3 and 6 months
As assessed by IBS specific questionnaires
Baseline, 4 weeks, 3 and 6 months
Change in metabolic profile
Time Frame: Baseline, 4 weeks, 6 months
Metabolomics in serum and urine samples
Baseline, 4 weeks, 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Qualitative assessment
Time Frame: Approx. at 3 months follow-up
Patient's subjective experiences related to the dietary intervention described by qualitative methods.
Approx. at 3 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sahlgrenska University Hospital, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 29, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Car-IBS 1511-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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