Fermentable dietary carbohydrates as triggers of functional gut symptoms in patients with inflammatory bowel disease

Not Applicable

Completed

• Conditions: Inflammatory bowel disease (Crohn?'s disease and ulcerative colitis); Digestive System; Noninfective inflammatory bowel disease

• Registration Number: ISRCTN98226923
• Lead Sponsor: King's College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-04
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Men and women aged 18 years or over
2. Individuals able to give informed consent
3. Diagnosis of IBD confirmed by standard clinical, histological and radiological criteria
4. Diagnosis of IBD for duration of at least 6 months. IBD in remission as defined by physician global assessment, patient report and two markers of absence of inflammation: C-reactive protein (CRP) <10mg/l and faecal calprotectin <250µg/g.
5. Stable medications (see exclusion criteria), no recent surgery (see exclusion criteria) and stable symptoms for at least 2 months
6. Diagnosis of functional bowel disorder as defined by Rome III criteria (IBS or functional bloating or functional diarrhoea or functional abdominal pain syndrome) with marked and sustained improvement of these symptoms on the low fermentable carbohydrate diet
7. A willingness to participate

Exclusion Criteria

1. Patients with active IBD
2. Recent use of the following treatments: antibiotics or prebiotics in the preceding 4 weeks, non steroidal anti-inflammatory drugs (NSAIDs) during the preceding week.
3. Currently taking steroids
4. Recent changes in dose to the following treatments: azathioprine, 6-mercaptopurine, methotrexate or alpha tumor necrosis factor (alpha-TNF) agents during the preceding 12 weeks, oral 5-aminosalicylic acid (5-ASA) or steroids during the preceding 4 weeks
5. Previous panproctocolectomy, pure perianal disease or short bowel syndrome
6. Stenotic disease
7. Sepsis or fever
8. Diabetes or coeliac disease (by serology and/or duodenal biopsy)
9. Other concomitant serious comorbidity e.g. significant hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease
10. Pregnancy or lactation
11. Taking any medications with the potential to influence gastrointestinal symptoms unless taking a long term stable dose that is unlikely to change or stop during the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To find out whether FGS are adequately controlled following rechallenge with individual FODMAPs compared with a placebo, glucose. This will be measured by a Global Symptom Question ?Do you currently have satisfactory relief of your gut symptoms?? with a 'yes' or 'no' response. This will be measured at baseline, for 3 days during each test and on day 4 of the washout phase to ensure symptoms have returned to baseline.

Secondary Outcome Measures

Name	Time	Method
1. Ratings and mean scores for individual symptoms during each test phase, measured by the Gastrointestinal Symptom Rating Scale at baseline, for 3 days during each test and on day 4 of the washout phase.<br>2. Faecal calprotectin and serum CRP levels, measures of inflammation, measured at baseline and at the end of the trial