Dietary Treatment for IBS Within Primary Health Care

Study Overview
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Brief Summary
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Irritable bowel syndrome (IBS) is a multifaceted disorder where diet plays a pivotal role in symptom generation and management. The traditional dietary advice given to patients in clinical settings are based on the NICE guidelines. Some of the advice included in these guidelines have limited scientific evidence. The aim of this study is to investigate the effectiveness of the traditional dietary advice in IBS, according to the NICE guidelines, within a primary health care setting, where treatment is delivered digitally and in groups of 8-12 individuals. As a sham comparator, one group will receive dietary advice according to the Swedish dietary guidelines regarding healthy eating habits.

Official Title
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Dietary Treatment for IBS Within Primary Health Care

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Other: Online dietary group treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with IBS (ROME IV) by physician Age 18-50 Ability to read and understand Swedish Signed informed consent Exclusion Criteria: Received dietary treatment for IBS previously Manifestations of other conditions that may explain gastrointestinal symptoms

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention study with 2 parallel arms (1:1)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IBS dietary advice according to the NICE guidelines<br>The traditional dietary advice according to the NICE guidelines and the systematic reviews performed by the British dietetic association (BDA) include having regular meals and to take time to eat, not to skip meals or eat too much at ones. The diet also limits intake of known trigger foods, such as coffee, alcohol, fizzy drinks, spicy foods, fatty foods etc. People who experience loose stools are recommended to avoid sweeteners (-ol), and people with wind/bloating are recommended to eat soluble fibers such as oats and flaxseeds. | Other: Online dietary group treatment<br>* Dietary advice will be given during one 90 minute online group session<br>|
| Sham Comparator: A healthy diet according to the Swedish dietary guidelines<br>This diet includes eating 500 grams of vegetables and fruits/day, fish approximately 3 times/week, 70 grams of wholegrain/day and to limit intake of red meat. | Other: Online dietary group treatment<br>* Dietary advice will be given during one 90 minute online group session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with significant symptom reduction | A responder to treatment is defined as having a symptom reduction >50 measured by IBS-SSS | From baseline vs. 6 weeks after group session |