Personalized Lifestyle Program in Treatment Resistant Irritable Bowel Syndrome

Karolinska Institute

Status

Enrolling

Conditions

Irritable Bowel Syndrome

Treatments

Other: Personalized lifestyle treatment program

Study type

Interventional

Funder types

Other

Identifiers

NCT05028036

Skandia-IBS

Details and patient eligibility

About

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

Full description

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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