Bile salt manipulation as a novel treatment for Crohn’s disease: a single centre open label pilot study of atorvastatin and colesevalam in patients with active ileal Crohn’s disease - Bile salt manipulation in Crohn’s disease
- Conditions
- Active Crohn's disease affecting the ileumMedDRA version: 9.1 Level: LLT Classification code 10011406 Term: Crohn's ileitisMedDRA version: 9.1 Level: LLT Classification code 10058815 Term: Crohn's disease acute episode
- Registration Number
- EUCTR2009-010163-16-GB
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 13
1) Able to give informed consent
2) Above or equal to 18 years of age
3) Diagnosis of ileal Crohn's disease (but may involve the ileocaecal valve and / or the upper GI tract if the Principle Investigator confirms such disease will not affect the CDAI score). Non-active perianal disease is also permissible.
4) Mild to moderate disease activity, defined as a Crohn's Disease Activity Index (CDAI) score of 151-400
5) Confirmation of normal bile salt aborption by either a negative SeHCAT scan or plasma lathosterol test within 6 months of enrolment into the study
6) a) Patients on no medication, or b) Patients 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 and / or c) 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)
9) 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
10)Stool sample negative for pathogenic bacteria and C. difficile toxin (if clinically indicated) during current episode of disease flare
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 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 section 11.3
7) Existing colostomy or ileostomy or 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 (ALT > twice ULN; creatinine ?150 ?mol/L)
9) Women who are currently or attempting to become pregnant, or those who are breast-feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the clinical benefit - in terms of mucosal healing and symptomatic improvement - of treatment with a combination of statins and cholestyramine (to reduce bile acid concentration) in patients with mild to moderately active ileal Crohn’s disease.;Secondary Objective: N/A;Primary end point(s): The proportion of patients experiencing a response, as defined by a 100 point fall in the Crohn's Disease Activity Index score, at Week 6 (end of treatment) compared to baseline.
- Secondary Outcome Measures
Name Time Method