Dietary Interventions in inflammatory bowel disease (IBD)

• Register: ISRCTN
• Last refreshed on: 29 October 2019
• Main ID: ISRCTN17061468
• Date of registration: 21/01/2016
• Prospective Registration: No
• Primary sponsor: King's College London
• Public title: Dietary Interventions in inflammatory bowel disease (IBD)
• Scientific title: Dietary interventions for the relief of functional gut symptoms in inflammatory bowel disease
• Date of first enrolment: 22/01/2015
• Target sample size: 52
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN17061468
• Study type: Interventional
• Study design: Randomised; Interventional; Design type: Treatment (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Selina Cox

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 symptoms). Both diets will involve restriction of certain foods, e.g. rice, wheat, bananas, cucumber, berries, and appropriate alternative options will be provided so that nutritional adequacy can be maintained. All participants are provided with written information for the diet to which they have been allocated, outlining foods to avoid and those which are permitted during the trial, in addition to supplementary information. Researchers will contact participants weekly to answer any questions or respond to concerns, to monitor compliance to the diet and to document any adverse events.

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

20402

Source(s) of Monetary Support

Kenneth Rainin Foundation

Ethics review

Status:
Approval date:
Contact:

Research Ethics Committee London – Dulwich, 22/10/2015, ref: 15/LO/1684

Results

• Results available: Yes
• Date Completed: 31/12/2017