Topic: Gastroenterology
Conditions
Interventions
Participants are randomly allocated to one of two groups who will consume the intervention diet (expected to have an effect on IBS-like symptoms) or sham diet (expected to have no effect on IBS-like s
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over 2. Diagnosis of IBD confirmed by standard clinical, histological and radiological criteria for least 6 months 3. Inactive disease state (deemed in remission by physician assessment, with GI symptoms that have been assessed with objective investigations and thought not to be a result of active inflammation, and which do not require escalation of IBD medications) 4. Stable medications (see exclusion criteria), and no GI surgery in preceding 6 months (also see exclusion criteria). 5. Have not experienced an IBD flareup in past 6 months 6. Faecal calprotectin <250µg/g (screening 2) 7. CRP <10mg/l (blood taken as part of routine outpatient appointment, but results checked during screening 2) 8. Functional symptoms meeting the following Rome III criteria: 8.1. IBS diarrhoea predominant, or IBS alternating subtype 8.2. Functional bloating 8.3. Functional diarrhoea 9. Symptoms must also meet the following criteria (screening 2): 9.1. Inadequate relief of gut symptoms at baseline according to the GSQ, assessed on day 7 of screening week (described previously) 9.2. Presence of mild, moderate or severe abdominal pain, bloating or diarrhoea, assessed using the GSRS, on at least 2 of 7 days of the screening week 10. Have not been exposed to the intervention diet in the past 11. Ability to give informed consent 12. A willingness to participate
Exclusion criteria
Exclusion criteria: 1. Any evidence of active disease, defined as: 1.1. Requiring a change in treatment as assessed by the treating physician 1.2. Currently taking steroids 1.3. Patients in whom surgery is thought to be imminent 2. Changes in dose to azathioprine, 6mercaptopurine, methotrexate or antiTNFa agents during the preceding 12 weeks, oral 5ASA during the preceding four weeks. 3. Constipation predominant symptoms (either meeting criteria for IBSC or functional constipation) 4. Recent use of the following treatments: antibiotics or probiotics (or prebiotics) in the preceding eight weeks, NSAIDs during the preceding week. 5. Pure perianal disease 6. Current stoma 7. Other factors likely to be cause of gut symptoms: 7.1. Previous extensive colonic resection, or extensive small intestinal resection indicating short bowel syndrome 7.2. Symptoms thought to relate to stenotic disease 7.3. Taking any medications with the potential to influence gastrointestinal symptoms, e.g. lactulose, loperamide, senna (unless taking longterm stable dose that is unlikely to change or stop during the trial) 7.4. Individuals with established bile acid malabsorption 8. Comorbidities: 8.1. Sepsis or fever 8.2. Diabetes or coeliac disease 8.3. Other concomitant serious comorbidity e.g. significant hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease 9. Seen by a dietitian in the preceding 6 months for advice regarding nutrition support 10. Pregnancy or lactation 11. Full bowel preparation for a diagnostic procedure in preceding 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut symptoms are measured using the Irritable Bowel Syndrome Severity Scoring System score at baseline and 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Gastrointestinal symptoms are measured using the gastrointestinal symptom rating scale at baseline and 4 weeks 2. Stool output (frequency and consistency) is measured using the Bristol Stool Form Scale at baseline and 4 weeks 3. Luminal gastrointestinal microbiota composition, defined as total and individual bacteria and proportions of bacteria, are measured using quantitative polymerase chain reaction and metagenomic sequencingis measured at baseline and 4 weeks 4. Gastrointestinal microbiota metabolites, including SCFA, are measured using gas liquid chromatography at baseline and 4 weeks 5. Peripheral blood mononuclear cell gut homing phenotype, including cell surface homing receptors, measured using multi-colour flow cytometry at baseline and 4 weeks 6. Inflammatory markers, including faecal calprotectin, are measured using ELISA (enzyme linked immunosorbent assay) at baseline and 4 weeks 7. Clinical disease activity is measured using the Harvey-Bradshaw Index (for patients with Crohn’s disease) and the partial Mayo score (for patients with ulcerative colitis) at baseline and 4 weeks 8. Patient reported outcome measures are measured using the IBD-control questionnaire and patient-reported outcome 2 (PRO2) questionnaire at baseline and 4 weeks 9. Health-related quality of life is measured using the inflammatory bowel disease questionnaire and the food-related quality of life questionnaire at baseline and 4 weeks 10. Nutritional intake is measured using 7-day un-weighed food records at baseline and 4 weeks | — |
Countries
United Kingdom
Contacts
Public ContactSelina Cox
Outcome results
None listed