Irritable Bowel Syndrome
Conditions
Keywords
FODMAPS, carbohydrates, metabolomics, microbiota
Brief summary
Irritable Bowel Syndrome is a common disease to which there is no curable treatment. Diet is considered to trigger symptoms associated with the clinical picture of IBS, and dietary treatment is thus believed to relieve the symptoms of IBS. As the disease is very heterogeneous in its manifestation, different treatment options might be indicated depending on the predominant symptom. To investigate the response to different dietary treatment options, a randomized controlled intervention trial will be carried out in adult patients (\>18 y) with IBS according to Rome IV criteria. The aim of this study is to compare the response to two different dietary treatments or optimized medical treatment.
Detailed description
The study is a randomized controlled trial comparing three different treatments during four weeks: 1. Combination of low FODMAP diet + traditional dietary advice (based on NICE recommendations) * Eat at regular hours; 3 main meals and 3 snacks * Eat in peace, chew the food properly * Peel all fruits and vegetables * Limit intake of spicy and fatty foods, coffe, alcohol, avoid fizzy drinks and chewing gum * Choose soluble rather than insoluble fibres * Avoid foods high in FODMAPs 2. Diet low in carbohydrates * 10 E% carbohydrates, 23 E% protein, 67 E% fat * Larger amounts of fish, shellfish, meat, egg, dairy products (lactose free if wanted) nuts, seeds, oil, vegetables * No sugary or starchy foods, e.g pasta, potatoes, bread, rice, most fruits * No specific consideration about FODMAP content 3. Optimized pharmacological tretament based on predominant symptom and previous experience with pharmacological treatmment. Pain/discomfort: * Pain: Amitriptyline 25 mg. Increase to 50 mg if needed * Episodic pain: Hyoscyamine 0,2mg 2x2; adjust dose if needed * Pain with diarrhea: Amitriptyline 25 mg. Increase dose if needed * Pain with constipation: Linaclotide 290 microgram 1x1 Constipation: * Bulking agent (Sterculia gum (Inolaxol) 1x1. Increase to 1x3 if needed * Osmotic laxative (Macrogol (Movicol) 1x1 * Linaclotide 290 microgram 1x1 Diarrhea * Loperamide 1x2 . Adjust dose if needed * Cholestyramine 1x1. Increase ever 3-5 d as needed * Ondansetron 4mg 1x1. Increase to 1x2-3 if needed * Eluxadoline 100mg 1x2 Primary endpoint: IBS-SSS reduction \>50 points
Interventions
OTHERTraditional dietary advice and low FODMAP content
Traditional dietary advice according to the Brittish Dietetic Association including reducing the intake of fermentable carbohydrates.
OTHERLow carbohydrate diet
Diet that contains a maximum of 10 energy percent of carbohydrates, 23 energy % proteins and 67 energy % fat.
Standard consultation by physician and if needed patients will receive medical treatment based on the most prominent symptom. Constipation: osmotic laxatives, linaclotide. Diarrhea: loperamid, bile acid binders. Pain: anti depressent, antispasmodics, linaclotide.
Sponsors
Sahlgrenska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* IBS according to ROME IV criteria, BMI 18-35, ability to communicate in Swedish, Gothenburg region resident
Exclusion criteria
* Heart, liver, neurologic or psychiatric disease or illness * Serious gastrointestinal diseases * Celiac disease * Diabetes * Other conditions or surgery that affects the gastrointestinal function * Hyperlipidemia * Food allergy or intolerance other than lactose * Adherence to a specific diet * Being pregnant or breastfeeding * Previously been treated with any of the intervention arms, including having tested all of the pharmacological treatment options of relevance for the symptom profile of the patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion (%) of patients who respond to treatment | Baseline to 4 weeks | A responder is defined as having an IBS-SSS reduction \>50 points @ 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in symptom severity | Baseline, 4 weeks, 3 and 6 months | Absolute and percentage change in IBS-SSS |
| Determinants for GI symptoms by IBS-SSS | Baseline, 4 weeks, 3 and 6 months | GI symptoms measured by IBS-SSS |
| Determinants for GI symptoms by GSRS-IBS | Baseline, 4 weeks, 3 and 6 months | GI symptoms measured by GSRS-IBS |
| Predictors of response to treatment | Baseline to 4 weeks | Potential predictors include demographics, questionnaire data, microbiota, metabolites, immunology |
| Change in microbiota content | Baseline, 4 weeks, 6 months | Fecal microbiota analysis using 16S technique |
| Change in extra-intestinal symptoms and quality of life | Baseline, 4 weeks, 3 and 6 months | As assessed by IBS specific questionnaires |
| Change in metabolic profile | Baseline, 4 weeks, 6 months | Metabolomics in serum and urine samples |
| Adherence to allocated intervention | Baseline, 4 weeks, 3 and 6 months | Including compliance to dietary intervention during 4 weeks, and long-term adherence during follow-up |
Other
| Measure | Time frame | Description |
|---|---|---|
| Qualitative assessment | Approx. at 3 months follow-up | Patient's subjective experiences related to the dietary intervention described by qualitative methods. |
Countries
Sweden
Outcome results
None listed