Personalized Lifestyle Program in Treatment Resistant Irritable Bowel Syndrome

NCT ID: NCT05028036

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-14
• Study Completion Date: 2025-09-14

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Personalized lifestyle intervention

The intervention consists of a personalized lifestyle treatment program to address specific lifestyle issues.

Group Type: EXPERIMENTAL

Personalized lifestyle treatment program

Intervention Type: 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:

• 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.

Interventions

Personalized lifestyle treatment program

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stockholm University

OTHER

Sponsor Role: collaborator

Karolinska University Hospital

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Greger Lindberg

Clinical Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Greger Lindberg

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska Institutet Departmend of Medicine Hudding

Huddinge, Stockholm County, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Greger Lindberg

Role: CONTACT

greger.lindberg@ki.se

+46736997395

Anna Andreasson

Role: CONTACT

anna.andreasson@ki.se

Facility Contacts

Greger Lindberg

Role: primary

greger.lindberg@ki.se

Other Identifiers

Skandia-IBS

Identifier Type: -

Identifier Source: org_study_id