Dietary Interventions in inflammatory bowel disease (IBD)

Not Applicable

Completed

• Conditions: Topic: Gastroenterology; Subtopic: Gastroenterology; Disease: All Gastroenterology; Digestive System; Inflammatory bowel disease (IBD)

• Registration Number: ISRCTN17061468
• Lead Sponsor: King's College London

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31586453 (added 07/10/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-21
• Study Completion: 2017-12-31
• Last Update Posted: 29 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 52

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut symptoms are measured using the Irritable Bowel Syndrome Severity Scoring System score at baseline and 4 weeks.