Personalized lifestyle program for treatment-resistant irritable bowel syndrome
Personalized Lifestyle Program in Treatment Resistant Irritable Bowel Syndrome
NA · Karolinska Institutet · NCT05028036
This study is testing a personalized lifestyle program to see if it can help people with treatment-resistant irritable bowel syndrome feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet (other) |
| Locations | 1 site (Huddinge, Stockholm) |
| Trial ID | NCT05028036 on ClinicalTrials.gov |
What this trial studies
This clinical trial recruits patients with treatment-resistant irritable bowel syndrome (IBS) from gastroenterology clinics in Stockholm. Participants undergo a 12-month personalized lifestyle intervention program at Nordic Clinic, which is based on the functional medicine model. The program includes dietary changes, supplements, sleep improvement, stress management, and exercise, tailored to each participant's needs. Participants are assessed clinically at multiple intervals to evaluate the effectiveness of the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults who meet the Rome IV criteria for IBS and have not found relief from standard medical treatments.
Not a fit: Patients who are pregnant or have other diseases or life circumstances that prevent participation in the treatment program may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could provide significant relief and improved quality of life for patients suffering from treatment-resistant IBS.
How similar studies have performed: While personalized lifestyle interventions are gaining traction, this specific approach for treatment-resistant IBS is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Huddinge, Stockholm
- Karolinska Institutet Departmend of Medicine Hudding — Huddinge, Stockholm, Sweden (RECRUITING)
Study contacts
- Principal investigator: Greger Lindberg — Karolinska Institutet
- Study coordinator: Greger Lindberg
- Email: greger.lindberg@ki.se
- Phone: +46736997395
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Irritable Bowel Syndrome