Personalized Lifestyle Program in Treatment Resistant Irritable Bowel Syndrome

Not Applicable

Recruiting

• Conditions: Irritable Bowel Syndrome
• Interventions: Other: Personalized lifestyle treatment program

• Registration Number: NCT05028036
• Lead Sponsor: Karolinska Institutet

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.

Study Timeline

• Study Start: 2021-06-14
• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-08-28
• Study First Posted: 2021-08-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-19
• Last Update Posted: 2023-06-22
• Primary Completion: 2024-09-14
• Study Completion: 2025-09-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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)

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Exclusion Criteria

• Pregnancy
• Disease or life circumstances that prevent participation in the treatment program

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Personalized lifestyle intervention	Personalized lifestyle treatment program	The intervention consists of a personalized lifestyle treatment program to address specific lifestyle issues.

Primary Outcome Measures

Name	Time	Method
Proportion recovery from diagnosis of IBS	12 months	Rome IV questionnaire is used to establish whether the participant fulfills the criteria for IBS at 12 months follow up

Secondary Outcome Measures

Name	Time	Method
Change in BS severity symptom scale score	Baseline, 6, 12, 18 and 24 months	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
Change in total symptom burden	Baseline, 6, 12, 18 and 24 months	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
Change in work ability	Baseline, 6, 12, 18 and 24 months	The participant is asked to rate its work ability and to report current employment rate and sick leave.

Trial Locations

Locations (1)

Karolinska Institutet Departmend of Medicine Hudding; 🇸🇪 Huddinge, Stockholm, Sweden