Bile salt manipulation in Crohn'?s disease

Phase 2

Completed

Conditions: Crohn's disease localised to the terminal ileum
Digestive System
Crohn's disease [regional enteritis]

Registration Number: ISRCTN77283008

Lead Sponsor: niversity College London (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 13

Inclusion Criteria

1. Able to give informed consent
2. Greater than 18 years of age, either sex
3. Diagnosis of Crohn's disease confined to the terminal ileum (but may involve the ileocaecal valve)
4. Mild to moderate disease activity, defined as a Crohn's Disease Activity Index (CDAI) score of 220 - 400
5. Negative SeHCAT scan within 6 months of enrolment into the study
6. Patients:
6.1. On no medication
6.2. Who have received aminosalicylates or nutritional supplements for at least 8 weeks prior to screening with no clinically relevant change in dose (as determined by the investigator) within 4 weeks
6.3. Are receiving immunosuppressants (except steroids) commenced at least 12 weeks prior to screening and been on a stable dose for at least 4 weeks
7. Able to comply with trial requirements (drug taking and visits)
8. Negative serum pregnancy test in females of child-bearing potential, who must agree to use an adequate method of contraception for the duration of trial
9. Stool sample negative for pathogenic bacteria and C. difficile toxin (if clinically indicated) during current episode of disease flare

Exclusion Criteria

1. Fasting triglyceride level greater than 3.4 mmol/L
2. Use of oral or parenteral steroids within four weeks or infliximab within eight weeks of start of trial medication; use of any investigational medication within the preceding 3 months
3. Use of antibiotics as treatment for the Crohn's disease within 4 weeks of screening
4. Current use of a 3-hydroxy-3-methyl-glutaryl-CoA (HMG CoA) reductase inhibitor or bile acid sequestrants, or use within 12 weeks of screening
5. Known intolerance to either HMG CoA reductase inhibitors or bile acid sequestrants
6. Taking any of the prohibited medications listed in protocol
7. Existing colostomy or ileostomy; current symptoms of bowel obstruction; any other severe concurrent morbidity including bleeding disorders or active upper gastrointestinal peptic ulceration; likely need for hospitalisation during the period of the study
8. Significant hepatic or renal dysfunction (alanine aminotransferase [ALT] greater than twice the upper limit of normal [ULN]; creatinine greater than 150 µmol/L)
9. Women who are currently or attempting to become pregnant, or those who are breast-feeding

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response, as defined by a 100 point fall in the Crohn's Disease Activity Index (CDAI) score at week 6 compared to baseline

Secondary Outcome Measures

Name	Time	Method
1. Remission (defined as an absolute Crohn's Disease Activity Index (CDAI) score of less than or equal to 150) at week 6<br>2. Mucosal healing (as defined by a faecal calprotectin level of less than or equal to 50 mg/kg) at week 6<br>3. Serum C-reactive protein level at week 6 compared with baseline