NCT05028036

Personalized Lifestyle Program in Treatment Resistant Irritable Bowel Syndrome

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2021-06-14
• Primary completion: 2024-09-14
• Completion: 2025-09-14
• First posted: 2021-08-31
• Last updated: 2023-06-22

Locations

1 site across 1 country: Sweden