Irritable Bowel SyndromeNCT05028036
Personalized Lifestyle Program in Treatment Resistant Irritable Bowel Syndrome
A study testing Personalized lifestyle treatment program in people with Irritable Bowel Syndrome, run by Karolinska Institutet at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Personalized lifestyle treatment program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 14 Jun 2021to 14 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Pregnancy
- Disease or life circumstances that prevent participation in the treatment program
Trial locations and contacts
1 site in 1 country.
Anna Andreasson contact
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet Departmend of Medicine Hudding
Huddinge, Stockholm County
Greger Lindberg, greger.lindberg@ki.se
Greger Lindberg
About this study
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
Read the 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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Personalized lifestyle treatment program
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized lifestyle treatment programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalized lifestyle intervention | Experimental | The intervention consists of a personalized lifestyle treatment program to address specific lifestyle issues. Receives: Other: Personalized lifestyle treatment program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (3)
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
Measured: 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
Measured: 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.
Measured: Baseline, 6, 12, 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start14 Jun 2021
- Primary completion14 Sep 2024 (estimated)
- Study completion14 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm University, Karolinska University Hospital
- Responsible party
- Principal investigator, Greger Lindberg, Karolinska Institutet
- Investigators
- Greger Lindberg, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028036
- Sponsor's protocol ID
- Skandia-IBS
- Status last verified
- Jun 2023
- First submitted
- 24 Aug 2021
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Lifestyle Program in Treatment Resistant Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT05028036
- Acronym / sponsor ID
- Skandia-IBS
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Stockholm University, Karolinska University Hospital
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 14 Sep 2024 (estimated)
- Study completion
- 14 Sep 2025 (estimated)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personalized lifestyle intervention | Experimental | Other: Personalized lifestyle treatment programThe intervention consists of a personalized lifestyle treatment program to address specific lifestyle issues. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Pregnancy
- Disease or life circumstances that prevent participation in the treatment program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized lifestyle treatment programThe 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. | Other | Personalized lifestyle intervention |
Primary outcome
Proportion recovery from diagnosis of IBS
Time frame: 12 months
Rome IV questionnaire is used to establish whether the participant fulfills the criteria for IBS at 12 months follow up
3 secondary outcomes
Change in BS severity symptom scale score
Time frame: Baseline, 6, 12, 18 and 24 months
Change in total symptom burden
Time frame: Baseline, 6, 12, 18 and 24 months
Change in work ability
Time frame: Baseline, 6, 12, 18 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Andreasson contact
Greger Lindberg principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized lifestyle treatment program in people with Irritable Bowel Syndrome, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Greger Lindberg (+46736997395, greger.lindberg@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion recovery from diagnosis of IBS (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.