Personalized Lifestyle Program in Treatment Resistant Irritable Bowel Syndrome

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

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Other: Personalized lifestyle treatment program

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Greger Lindberg; Phone Number: +46736997395; Email: greger.lindberg@ki.se
• Study Contact Backup: Name: Anna Andreasson; Email: anna.andreasson@ki.se

Study Locations

• Sweden
  • Stockholm
    • Huddinge, Stockholm, Sweden
      • Recruiting
      • Karolinska Institutet Departmend of Medicine Hudding
      • Contact: Greger Lindberg; Email: greger.lindberg@ki.se
      • Principal Investigator: Greger Lindberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Personalized lifestyle intervention; The intervention consists of a personalized lifestyle treatment program to address specific lifestyle issues.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Karolinska University Hospital; Stockholm University
• Investigators: Principal Investigator: Greger Lindberg, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Estimated): September 14, 2024
• Study Completion (Estimated): September 14, 2025

Study Registration Dates

• First Submitted: August 24, 2021
• First Submitted That Met QC Criteria: August 28, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: Skandia-IBS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No