ISRCTN17061468已完成未知
Dietary interventions for the relief of functional gut symptoms in inflammatory bowel disease
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 52
研究概览
简要总结
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31586453 (added 07/10/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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