Irritable Bowel SyndromeNCT07607132
Digitally Delivered Dietary Treament for Adult Patients With Irritable Bowel Syndrome: A Pilot Study
A study testing Digital dietary platform in people with Irritable Bowel Syndrome, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Two carbohydrate reduced diets, the low FODMAP diet (LFD) and low-carbohydrate diet (LCD), have in randomized controlled studies shown efficacy in relieving symptoms in patients with Irritable Bowel Syndrome (IBS), but access to trained dieticians is limited. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Digital dietary platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- 2 May 2024to 1 Apr 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with IBS (Rome IV) by physician
- Age 18-64
- Ability to read and understand Swedish
- Signed informed consent
Who cannot join
- Received dietary treatmen for IBS previously
- Manifestations of other conditions that may explain gastrointestinal symptoms
- Manifestation of other serious medical conditions
- Patients with ongoing eating disorders
- Pregnant/lactating women
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of Internal Medicine, Sahlgrenska University Hospital
Gothenburg, 41345
About this study
Official title: Digitally Delivered Dietary Treament for Irritable Bowel Syndrome
Two carbohydrate reduced diets, the low FODMAP diet (LFD) and low-carbohydrate diet (LCD), have in randomized controlled studies shown efficacy in relieving symptoms in patients with Irritable Bowel Syndrome (IBS), but access to trained dieticians is limited. Digital delivery may offer a convenient, cost-effective and scalable solution. This pilot study aims to evaluate the effectiveness and feasibility of digitally delivered evidence-based dietary treatments in relieving gastrointestinal, psychological and somatic symptoms and improving quality of life in patients with IBS.
Adults with IBS will be recruited via social media and clinical referrals and will receive their choice of the two dietary treatments: LFD with traditional IBS dietary advice or LCD. Participants will get access to the digital platform which contains information about the study, IBS pathophysiology, the treatment diet along with recipes and a mobile application for food scanning. Participants will complete digital questionnaires at baseline and week four to evaluate changes in gastrointestinal symptoms (IBS-SSS), somatic and psychological symptoms (PHQ-15, HADS, VSI) and quality of life (IBS-QoL). Feasibility and adherence is assessed with an evaluation questionnaire.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Digital dietary platform
- Keywords
- IBS, dietary treatment, digital
- 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.
Digital dietary platformOther
a digital platform with information about the study, IBS, the treatment diet along with recipes and a mobile application for food scanning.
| Study group | Role | What they receive |
|---|---|---|
| Digital delivery of low FODMAP diet or low-carbohydrate diet | Other | Not described Receives: Other: Digital dietary platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with significant gastrointestinal symtom reduction
A responder to treatment is defined as having a symptom reduction > 50 measured by IBS-SSS
Measured: From baseline vs 4 weeks after starting digital dietary treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start2 May 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
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 Sahlgrenska 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Effect of digital dietary treatment with either of the two treatments diets. Participants choose from the two diets.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Funding: Kostfonden
- Responsible party
- Principal investigator, Magnus Simrén, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607132
- Sponsor's protocol ID
- 2024-01068-01
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digitally Delivered Dietary Treament for Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT07607132
- Acronym / sponsor ID
- 2024-01068-01
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS, dietary treatment, digital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Funding: Kostfonden
- Study start
- 2 May 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 26 May 2026 (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.
Two carbohydrate reduced diets, the low FODMAP diet (LFD) and low-carbohydrate diet (LCD), have in randomized controlled studies shown efficacy in relieving symptoms in patients with Irritable Bowel Syndrome (IBS), but access to trained dieticians is limited. Digital delivery may offer a convenient, cost-effective and scalable solution. This pilot study aims to evaluate the effectiveness and feasibility of digitally delivered evidence-based dietary treatments in relieving gastrointestinal, psychological and somatic symptoms and improving quality of life in patients with IBS.
Adults with IBS will be recruited via social media and clinical referrals and will receive their choice of the two dietary treatments: LFD with traditional IBS dietary advice or LCD. Participants will get access to the digital platform which contains information about the study, IBS pathophysiology, the treatment diet along with recipes and a mobile application for food scanning. Participants will complete digital questionnaires at baseline and week four to evaluate changes in gastrointestinal symptoms (IBS-SSS), somatic and psychological symptoms (PHQ-15, HADS, VSI) and quality of life (IBS-QoL). Feasibility and adherence is assessed with an evaluation questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Effect of digital dietary treatment with either of the two treatments diets. Participants choose from the two diets.
| Arm | Type | Receives |
|---|---|---|
| Digital delivery of low FODMAP diet or low-carbohydrate diet | Other | Other: Digital dietary platform |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed with IBS (Rome IV) by physician
- Age 18-64
- Ability to read and understand Swedish
- Signed informed consent
Key exclusion criteria (5 listed)
- Received dietary treatmen for IBS previously
- Manifestations of other conditions that may explain gastrointestinal symptoms
- Manifestation of other serious medical conditions
- Patients with ongoing eating disorders
- Pregnant/lactating women
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 |
|---|---|---|
| Digital dietary platforma digital platform with information about the study, IBS, the treatment diet along with recipes and a mobile application for food scanning. | Other | Digital delivery of low FODMAP diet or low-carbohydrate diet |
Primary outcome
Proportion of patients with significant gastrointestinal symtom reduction
Time frame: From baseline vs 4 weeks after starting digital dietary treatment.
A responder to treatment is defined as having a symptom reduction > 50 measured by IBS-SSS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Undecided
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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 Digital dietary platform in people with Irritable Bowel Syndrome, run by Sahlgrenska University Hospital 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 5 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: finished, as of the sponsor's last update on 28 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients with significant gastrointestinal symtom reduction (time frame: From baseline vs 4 weeks after starting digital dietary treatment.). 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 28 May 2026.