ISRCTN98226923Completed未知
Fermentable dietary carbohydrates as triggers of functional gut symptoms in patients with inflammatory bowel disease: a randomised controlled crossover trial
King's College London (UK)0 sites32 target enrollmentStarted: March 4, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 32
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
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