IBS - Irritable Bowel SyndromeDIGIBSNCT06117865
Digital Treatment of Irritable Bowel Syndrome (IBS)
A study testing Module 1, Module 2 and Module 3 in people with IBS - Irritable Bowel Syndrome, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The aim of this work is to identify whether the digital treatment program Mage-tarmskolen has an effect on patients with IBS. Our secondary objectives is to address multiple aspects of digital treatmtent success of the different modules. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- Module 1, Module 2 and Module 3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 728 participants
- Where
- 1 siteNorway
- Study dates
- 1 Dec 2023to 31 Dec 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with IBS in the primary or secondary healthcare service.
- Patients aged 18-70 years with IBS defined by the Rome IV criteria: Recurrent abdominal pain, on average at least 1 day per week during the previous 3 months, that is associated with two or more of the following: i) Defecation, either increased pain or pain relief, ii) Change in stool frequency, iii) Change in stool form (appearance)
- All participants >50 years: Colonoscopy within the last 5 years prior to study entry excluding other pathology
- Bank-ID and access to tablet, PC or smart phone.
- No known presence of: symptomatic endometriosis, Diabetes type 1 and 2, Malignant disease (excluding basalioma),
- No history of: severe psychiatric disorder, alcohol or drug abuse, inflammatory bowel disease, microscopic colitis, diverticulitis or ileus, major abdominal surgery (except appendectomy, cholecystectomy, caesarean section, and hysterectomy)
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- No "red flags'' indicating severe undiagnosed disease: Night sweats (Repeated episodes of extreme perspiration that may soak nightclothes or bedding), Unintentional weight loss (≥ 4.5 kilograms, or 5% of normal body weight) over less than 6 months without knowing the reason, or blood in stool
- Not pregnant
- Ability to comply with protocol requirements
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Digital Intervention Study to Assess the Effect of Internet Delivered Interventions, the Low FODMAP-diet, Behavioral Therapy or Both, Compared to Patient Education, on Measures of Gastrointestinal Symptom Relief and Quality of Life in Patients With Irritable Bowel Syndrome
The aim of this work is to identify whether the digital treatment program Mage-tarmskolen has an effect on patients with IBS. Our secondary objectives is to address multiple aspects of digital treatmtent success of the different modules. The patients will be randomized to one of four arms and will be delivered different kinds of digital treatment. All patients will have access to ask questions to a registered dietitian. Primary end point is the proportion of patients with treatment success in the low FODMAP, behavioral therapy or both groups, versus the patient education group (sham). Treatment effect is defined as an improvement of 50 points or more on the IBS severity scoring system at 3 months after treatment start compared to the score before treatment.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- Module 1, Module 2, Module 3, Module 4, Module 5
- Keywords
- digital treatment
- 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.
Module 1Behavioural
Module 1: Introduction to IBS by a gastroenterologist.
Module 2Behavioural
Module 2:Introduction to pain physiology and how the nervous system works by a physiotherapist including practical exercises.
Module 3Behavioural
Module 3: Evidence-based guidelines for diet and lifestyle advice (NICE Guidelines) by a clinical dietitian.
Module 4Behavioural
Module 4: Intervention: behavioral therapy (exposure therapy and cognitive behavioral therapy).
Module 5Behavioural
Module 5: Intervention: The low FODMAP diet.
| Study group | Role | What they receive |
|---|---|---|
| Patient education | Sham comparator | Not described Receives: Behavioral: Module 1; Behavioral: Module 2; Behavioral: Module 3 |
| Behavioral therapy | Active comparator | Not described Receives: Behavioral: Module 1; Behavioral: Module 2; Behavioral: Module 3; Behavioral: Module 4 |
| Low FODMAP-diet | Active comparator | Not described Receives: Behavioral: Module 1; Behavioral: Module 2; Behavioral: Module 3; Behavioral: Module 5 |
| Combined treatment | Active comparator | Low FODMAP-diet and behavioral therapy Receives: Behavioral: Module 1; Behavioral: Module 2; Behavioral: Module 3; Behavioral: Module 4; Behavioral: Module 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS-SSS
Treatment success is defined as an improvement of ≥50 points on the IBS severity scoring system (IBS-SSS) at 3 months after treatment start, compared to the score before treatment
Measured: 3 months after treatment start
Secondary outcomes (2)
IBS-QOL
≥10-point increase in the IBS-Qualiy of Life (IBS-QoL) at 3 months compared to the score before treatment.
Measured: 3 months after treatment start
HADS
≥3-point decrease in HADS at 3 months compared to the score before treatment.
Measured: 3 months after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Dec 2023
- Primary completion28 Feb 2025
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 728 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117865
- Sponsor's protocol ID
- 2023-630038
- Other IDs
- 2023
- Acronym
- DIGIBS
- Status last verified
- May 2024
- First submitted
- 31 Oct 2023
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thuen C, Kenter RMF, Assmus J, Steinsvik EK, Vikoren LAS, Lied GA, Berentsen B. Internet-delivered cognitive behavioral therapy and FODMAP diet for adults with irritable bowel syndrome: A four-arm randomized controlled trial. Internet Interv. 2026 Apr 26;44:100949. doi: 10.1016/j.invent.2026.100949. eCollection 2026 Jun.
PubMed 42094852
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Digital Intervention Study to Assess the Effect of Internet Delivered Interventions, the Low FODMAP-diet, Behavioral Therapy or Both, Compared to Patient Education, on Measures of Gastrointestinal Symptom Relief and Quality of Life in Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT06117865
- Acronym / sponsor ID
- DIGIBS / 2023-630038
- Conditions
- IBS - Irritable Bowel Syndrome
- Keywords
- digital treatment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 728 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 7 Nov 2023 (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.
The aim of this work is to identify whether the digital treatment program Mage-tarmskolen has an effect on patients with IBS. Our secondary objectives is to address multiple aspects of digital treatmtent success of the different modules. The patients will be randomized to one of four arms and will be delivered different kinds of digital treatment. All patients will have access to ask questions to a registered dietitian. Primary end point is the proportion of patients with treatment success in the low FODMAP, behavioral therapy or both groups, versus the patient education group (sham). Treatment effect is defined as an improvement of 50 points or more on the IBS severity scoring system at 3 months after treatment start compared to the score before treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patient education | Sham comparator | Behavioral: Module 1, Behavioral: Module 2, Behavioral: Module 3 |
| Behavioral therapy | Active comparator | Behavioral: Module 1, Behavioral: Module 2, Behavioral: Module 3, Behavioral: Module 4 |
| Low FODMAP-diet | Active comparator | Behavioral: Module 1, Behavioral: Module 2, Behavioral: Module 3, Behavioral: Module 5 |
| Combined treatment | Active comparator | Behavioral: Module 1, Behavioral: Module 2, Behavioral: Module 3, Behavioral: Module 4, Behavioral: Module 5Low FODMAP-diet and behavioral therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosed with IBS in the primary or secondary healthcare service.
- Patients aged 18-70 years with IBS defined by the Rome IV criteria: Recurrent abdominal pain, on average at least 1 day per week during the previous 3 months, that is associated with two or more of the following: i) Defecation, either increased pain or pain relief, ii) Change in stool frequency, iii) Change in stool form (appearance)
- All participants >50 years: Colonoscopy within the last 5 years prior to study entry excluding other pathology
- Bank-ID and access to tablet, PC or smart phone.
- No known presence of: symptomatic endometriosis, Diabetes type 1 and 2, Malignant disease (excluding basalioma),
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Module 1Module 1: Introduction to IBS by a gastroenterologist. | Behavioural | Behavioral therapy, Combined treatment, Low FODMAP-diet, Patient education |
| Module 2Module 2:Introduction to pain physiology and how the nervous system works by a physiotherapist including practical exercises. | Behavioural | Behavioral therapy, Combined treatment, Low FODMAP-diet, Patient education |
| Module 3Module 3: Evidence-based guidelines for diet and lifestyle advice (NICE Guidelines) by a clinical dietitian. | Behavioural | Behavioral therapy, Combined treatment, Low FODMAP-diet, Patient education |
| Module 4Module 4: Intervention: behavioral therapy (exposure therapy and cognitive behavioral therapy). | Behavioural | Behavioral therapy, Combined treatment |
| Module 5Module 5: Intervention: The low FODMAP diet. | Behavioural | Combined treatment, Low FODMAP-diet |
Primary outcome
IBS-SSS
Time frame: 3 months after treatment start
Treatment success is defined as an improvement of ≥50 points on the IBS severity scoring system (IBS-SSS) at 3 months after treatment start, compared to the score before treatment
2 secondary outcomes
IBS-QOL
Time frame: 3 months after treatment start
HADS
Time frame: 3 months after treatment start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Derived from this study: PubMed 42094852Thuen C, Kenter RMF, Assmus J, Steinsvik EK, Vikoren LAS, Lied GA, Berentsen B. Internet-delivered cognitive behavioral therapy and FODMAP diet for adults with irritable bowel syndrome: A four-arm randomized controlled trial. Internet Interv. 2026 Apr 26;44:100949. doi: 10.1016/j.invent.2026.100949. eCollection 2026 Jun.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Module 1, Module 2 and Module 3 in people with IBS - Irritable Bowel Syndrome, run by Haukeland University Hospital at 1 site in Norway.
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 9 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 16 May 2025. 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 Norway. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS-SSS (time frame: 3 months after treatment start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06117865, which also lists 1 linked publication.
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 16 May 2025.