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| Name | Class |
|---|---|
| Stockholm University | OTHER |
| Karolinska University Hospital | OTHER |
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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
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized lifestyle intervention | Experimental | The intervention consists of a personalized lifestyle treatment program to address specific lifestyle issues. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized lifestyle treatment program | Other | 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:
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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Greger Lindberg | Contact | +46736997395 | greger.lindberg@ki.se | |
| Anna Andreasson | Contact | anna.andreasson@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Greger Lindberg | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet Departmend of Medicine Hudding | Recruiting | Huddinge | Stockholm County | Sweden |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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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 |
| D004066 | Digestive System Diseases |