Effect of a Low- Fermentable-Oligo-Di- Monosaccharides and Polyols Diet Group Intervention on IBS Symptoms and Fatigue

Study Overview
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Brief Summary
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Irritable bowel disease (IBS) is a functional gastrointestinal disorder that affects 10% of the population. Comorbidities are common and fatigue is the most common extraintestinal complaint in IBS patients. There are no cure for the disease but there are nutrition treatments that can relieve symptoms. The main goal of this randomized controlled trial is to test the hypothesis that low-Fermentable- oligo-di- monosaccharides and polyols (FODMAPs) diet kan decrease gastrointestinal symptoms and improve quality of life and fatigue in patients with IBS.

Detailed Description
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Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by stomach pain at least one day a week accompanied by change in stool frequency or appearance. Prevalence of IBS is about 10 % of the population worldwide and more common in women. IBS is divided into different subclasses: diarrhea predominant, (IBS-D), predominant constipation, (IBS-C), mixed bowel habits, (IBS-M). Comorbidities are common and fatigue is the most common extraintestinal complaint among the patients. Patients has severely reduced quality of life, reduced work capacity and the cost are substantial for the patients and the society. IBS can´t be cured but the symptoms can be relieved by pharmacological as well as non-pharmacological treatment as psychological- and nutritional treatment. The main goal of this randomized controlled trial is to test the hypothesis that low FODMAPdiet kan decrease gastrointestinal symptoms and improve quality of life and fatigue in patients with IBS. FODMAPs is an acronym for Fermentable-Oligo-Di-Monosaccharides and Polyols. FODMAPs are carbohydrates that can't be absorbed/splinted in the large intestine and they ferment rapidly and exacerbate gastrointestinal symptoms as flatulence, pain, bloating and loose stools. In total 120 patients with IBS-D and IBS-M will be randomized to immediate treatment start or delayed treatment start. The treatment will be performed in clinical setting, led by a dietitian and in group format including 12 patients in each group. The intervention time is 12 weeks with 5 group visits at a gastroenterology unit. The low-FODMAP treatment is divided into three steps: elimination of FODMAPs, re-introduction and personalization of the diet. Compliance to the diet will be measured by monitoring the FODMAP intake from three day food diaries and a compliance form. Questionnaires will be self reported in a web based application. Food diaries and the stomach diary will be filled out at baseline, at week 5, 12 and 6, 12 and 24 months post intervention.

Official Title
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Effect of a Low- Fermentable-Oligo-Di-Monosaccharides and Polyols (FODMAPs) Diet Group Intervention on IBS Symptoms and Fatigue

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Other: Low- FODMAPdiet group intervention


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Established IBS-D by RomeIV- criteria Established IBS-M by RomeIV- criteria Body Mass Index (BMI)18-35 Exclusion criteria: Pregnancy Lactation Ongoing eating disorder/ contact with eating disorder unit Postoperative gastrointestinal surgery that may impact on the gastrointestinal function Celiac disease Psychiatric disorder Other disorder that may impact the possibility to participate in group treatment Diabetes Ongoing low- FODMAPdiet treatment.

Ages Eligible for Study
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Minimum Age: 18 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: Sequential Assignment
Interventional Model Description: Randomized controlled trial with direct or delayed treatment start
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-FODMAPdiet group<br>Low-FODMAPdiet intervention as group treatment in three steps during 12 weeks, elimination, re-introduction and personalization of the diet. This group of participants starts immediate. | Other: Low- FODMAPdiet group intervention<br>* Diet intervention<br>|
| Experimental: Delayed start of treatment low-FODMAPdiet group<br>Delayed start of treatment. This arm starts after three months | Other: Low- FODMAPdiet group intervention<br>* Diet intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in IBS Symptom Severity Scores (IBS-SSS) | Visual Analogues Scale (VAS-scale), composite score measuring bloating, bowel habits, satisfaction with with bowel habits and how IBS impact on QOL. Minimum score 0 and maximum score 500, higher scores indicates more severe disease | Change in baseline week 0 and after elimination at week 5, after intervention at week 12, at week 38 and at 1 year and 3 months and 2 years and three months. Within each patient. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Multidimensional Fatigue Inventory (MFI-20) | The Multidimensional Fatigue Inventory-20 (MFI-20) assesses 5 dimensions of fatigue, the severity of general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. Each dimension contain 4 questions. In total 20 questions. Minimum score 0 and maximum score 100. A higher score indicate more severe fatigue. | Between baseline week 0 and after elimination at week 5, after intervention at week 12, at week 38 and at 1 year and 3 months and at 2 years and three months. Within each patient. | 
| Change in the gastrointestinal symptom rating scale (GSRS-IBS) | Measuring gastrointestinal symptom severity. Contains 13 questions. Minimum score 13 and maximum score 91. Higher score indicate more severe gastrointestinal symptoms. | Between baseline week 0 and after elimination at week 5, after intervention at week 12, at week 38 and at 1 year and 3 months and at 2 years and three months. Within each patient. | 
| Change in Visceral sensitivity index (VSI) | The VSI questionnaire measures GI-specific anxiety, and it includes the cognitive, affective, and behavioral response to fear of GI symptoms, and the context in which these occurs. The questionnaire contains 15 questions. Minimum score 0 and maximum score 75. A higher score indicates a more severe gastrointestinal anxiety. | Baseline week 0 and after intervention at 12 weeks and at week 38 and at 1 year and 3 months and 2 years and three months. Within each patient. | 
| Change in Sickness behaviour (SQ) | Measuring symptoms that occur after acute or chronic inflammation/ infection ie. malaise, listlessness, inability to concentrate, depressed mood and lack of interest in food and surroundings. The form contains 10 questions. Minimum score 0 and maximum score 30. Higher score indicates more severe sickness behaviour. | Baseline week 0 after intervention at 12 weeks and at week 38, at 1 year and 3 months and 2 years and three months. Within each patient. | 
| Change in World Health Organisation (WHO) Disability Assessment Schedule (WHODAS 2.0) | Measuring difficulties due to state of health. 12 questions. Minimum score is 12 and maximum score is 48. Higher score indicates more severe difficulties due to state. | Baseline week 0 and at 12 weeks and at week 38, at 1 year and 3 months and 2 years and three months. Within each patient. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low FODMAPdiet