Personalized Lifestyle Program in Treatment Resistant Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

Personalized Lifestyle Program in Treatment Resistant Irritable Bowel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05028036
• Other study ID #: Skandia-IBS
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2021
• Est. completion date: September 14, 2025

Study information

• Verified date: June 2023
• Source: Karolinska Institutet
• Contact: Greger Lindberg
• Phone: +46736997395
• Email: greger.lindberg[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 14, 2025
• Est. primary completion date: September 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet Departmend of Medicine Hudding	Huddinge	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Karolinska University Hospital, Stockholm University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Change in total symptom burden	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
Secondary	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