Personalized Lifestyle Program in Treatment Resistant Irritable Bowel Syndrome

NCT05028036 | Unknown

• 1 other identifier: Skandia-IBS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in BS severity symptom scale score

  Baseline, 6, 12, 18 and 24 months

• Change in total symptom burden

  Baseline, 6, 12, 18 and 24 months

• Change in work ability

  Baseline, 6, 12, 18 and 24 months

Study Arms (1)

Personalized lifestyle intervention

EXPERIMENTAL

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

Other: Personalized lifestyle treatment program

Interventions

Personalized lifestyle treatment program 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.

Personalized lifestyle intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Stockholm University: collaborator
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska Institutet Departmend of Medicine Hudding

Huddinge, Stockholm County, Sweden

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Greger Lindberg

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Greger Lindberg

CONTACT

+46736997395; greger.lindberg@ki.se

Anna Andreasson

CONTACT

anna.andreasson@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, MD

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: August 31, 2021
• Study Start: June 14, 2021
• Primary Completion: September 14, 2024
• Study Completion: September 14, 2025
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)