Clinical trial NCT05028036: Personalized Lifestyle Program in Treatment Resistant Irritable Bowel Syndrome
Official title: Personalized Lifestyle Program in Treatment Resistant Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Stockholm University
name: Karolinska University Hospital
First posted: 2021-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion recovery from diagnosis of IBS
timeFrame: 12 months
Secondary outcomes:
measure: Change in BS severity symptom scale score
timeFrame: Baseline, 6, 12, 18 and 24 months
measure: Change in total symptom burden
timeFrame: Baseline, 6, 12, 18 and 24 months
measure: Change in work ability
timeFrame: Baseline, 6, 12, 18 and 24 months
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Karolinska Institutet Departmend of Medicine Hudding
state: Stockholm
Study officials:
affiliation: Karolinska Institutet
name: Greger Lindberg
role: PRINCIPAL_INVESTIGATOR
References: