A randomised, double-blind comparison of the microbiological, immunological and clinical effects of a high fructooligosaccharide diet compared with standard diet in patients with moderately active Crohn's disease

Completed

• Conditions: Moderatly active Crohn's disease; Digestive System; Crohn's disease

• Registration Number: ISRCTN50422530
• Lead Sponsor: Barts and the London NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-16
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. The study group will include patients aged 18 years or older with a diagnosis of Crohn?s disease for at least three months defined by histology or radiology
2. Patients must have moderately active disease as defined by a Crohns disease activity index (CDAI) between 250 and 450 at the baseline visit
3. Only patients with a C-reactive protein (CRP) elevated to above the upper limit of normal of the local laboratory will be included
4. Patients must be on stable Crohn?s disease therapy with a total steroid dose not exceeding 10 mg prednisolone or equivalent
5. Patients currently taking maintenance oral 5-aminosalicylic acid therapy must have been on a stable dose for four weeks prior to study entry, and will be maintained at the same dose for the six-week duration of the study
6. No rectally administered medications (steroid or 5-aminosalicylic acid [5ASA]) are allowed for the two weeks preceding baseline and throughout the study
7. Patients on a stable dose of oral steroids (not exceeding 10 mg prednisolone or equivalent) for four weeks prior to baseline are permitted to enter the study, and will remain on that dose throughout the study
8. Patients taking azathioprine or 6-mercaptopurine must have been maintained on a stable dose for at least 16 weeks prior to entry and will continue at that dose throughout the study
9. No antibiotics, probiotics or prebiotics (other than the study prebiotic) will be used during the study or for the preceding month
10. Food frequency questionnaires will be used to assess the consumption of foods that naturally contain prebiotics, although levels within a normal western diet are usually insufficient to affect the composition of the intestinal microbiota
11. Non-steroidal anti-inflammatory drugs (NSAIDs) will not be permitted for one week before and throughout the six-week study period

Exclusion Criteria

1. Current infection with an enteric pathogen
2. Use of antibiotics within the last month
3. Consumption of any probiotic within the last month
4. Change in dose of oral steroids within the last four weeks
5. Dose of steroids exceeds 10 mg prednisolone per day or equivalent
6. Change in dose of oral 5-ASA products within the last four weeks
7. Change in dose of azathioprine or methotrexate within the last three months
8. Infusion of infliximab within the last three months
9. Use of any alternative biological therapy within the last three months
10. Use of rectal 5-ASA or steroids within the last two weeks
11. Imminent need for surgery or presence of severe disease (CDAI >450)
12. Patient requiring hospitalization
13. Pregnancy or lactation
14. Short bowel syndrome
15. Pure anal disease and previous proctocolectomy
16. Patients will also be excluded if they have significant hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease as determined by the principal investigator
17. History of cancer with a disease-free state of less than two years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is clinical response to therapy at week four. Clinical response will be defined as a reduction in the Crohn?s disease activity index of at least 70 points from baseline.

Secondary Outcome Measures

Name	Time	Method
1. Disease remission at week four (defined as a reduction in Crohn?s disease activity index by at least 70 points and to less than 150)<br>2. Reduction in Harvey Bradshaw index from baseline to week four<br>3. Clinical response and remission at week twelve<br>4. Reduction in CRP<br>5. Improvement in quality of life at week four and twelve as determined by the Inflammatory Bowel Disease Questionnaire (IBDQ)<br>6. Avoidance of further therapeutic manipulations to control disease activity at week four and twelve<br>7. Compliance and tolerability of FOS<br><br>We will also assess the microbiological and immunological affects of FOS in a subset of patients.