Personalized Lifestyle Program in Treatment Resistant Irritable Bowel Syndrome

Study Overview
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Brief Summary
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Patients with treatment resistant irritable bowel syndrome (IBS) are recruited from secondary care gastroenterology clinics in Stockholm and screened for eligibility criteria. Participants follow a 12 month treatment program at Nordic Clinic, a clinic offering personalized lifestyle interventions based on the functional medicine model. In parallel with the treatment program, the participant are clinically assessed for the evaluation of the treatment after 6 months, 12 months, 18 months and 24 months

Detailed Description
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Patients with treatment resistant irritable bowel syndrome (IBS) are recruited from secondary care gastroenterology clinics in Stockholm. Eligible participants are screened for eligibility criteria at a baseline visit at the Karolinska Institutet. Patients providing written informed consent for participation are invited to Nordic Clinic, a clinic offering personalized lifestyle interventions based on the functional medicine model. Before the first visit to the clinic, the participant fill out a longer questionnaire that is used for the planning of the participant's personal treatment program. At the first visit, the therapist goes through the responses together with the participant. Based on the participant's symptom profile, it is determined which tests are taken in the first step. Based on symptoms and test results, the therapist and participant come up with a treatment plan that can include several of the following components: Dietary changes Dietary supplements Measures to improve sleep / circadian rhythm Stress management Physical exercise Medicines, in exceptional cases. The treatment plan is evaluated continuously by the participant and the therapist and adjusted accordingly. The treatment involves a total of 9 visits to the Nordic Clinic during one year. The subsequent visits are planned by the therapist at the Nordic Clinic together with the participant. In parallel with the treatment program, the participant makes return visits to Karolinska Institutet to collect follow-up data for the evaluation of the treatment after 6 months, 12 months, 18 months and 24 months after the start of treatment where participants are clinically assessed and fill out forms for the evaluation of treatment.

Official Title
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Personalized Lifestyle Program in Treatment Resistant Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Other: Personalized lifestyle treatment program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fulfills Rome IV criteria for IBS Symptom burden on IBS-SSS >175 No symptom relief from standard medical treatment No organic finding explaining the IBS symptoms (e.g. inflammation, parasites, thyroid disease, lactose intolerance, celiac disease, bile acid malabsorption) Exclusion Criteria: Pregnancy Disease or life circumstances that prevent participation in the treatment program

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized lifestyle intervention<br>The intervention consists of a personalized lifestyle treatment program to address specific lifestyle issues. | Other: Personalized lifestyle treatment program<br>* The personalized treatment program is based on the participants symptom profile and test results and is designed in collaboration with the participant. The treatment plan that may include several of the following components: Dietary changes Supplements Measures to improve sleep / circadian rhythm Stress management Physical exercise The treatment plan is evaluated continuously by the participant and the therapist and adjusted accordingly. A total of 9 visits to the Nordic Clinic over one year is included in the treatment program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion recovery from diagnosis of IBS | Rome IV questionnaire is used to establish whether the participant fulfills the criteria for IBS at 12 months follow up | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BS severity symptom scale score | Assessed using the IBS severity symptom scale (IBS-SSS) which goes from 0-500. At least 150 is required to enter the study. A change of 75 is usually considered clinically relevant | Baseline, 6, 12, 18 and 24 months | 
| Change in total symptom burden | Assessed using Gastrointestinal symptom rating scale for IBS (GSRS-IBS) scores This scale has 13 items, each scored 1-7 so the score goes from 13-91 | Baseline, 6, 12, 18 and 24 months | 
| Change in work ability | The participant is asked to rate its work ability and to report current employment rate and sick leave. | Baseline, 6, 12, 18 and 24 months |