Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01203254
• Date of registration: 15/09/2010
• Prospective Registration: Yes
• Primary sponsor: Florian Beigel
• Public title: Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease COBAM
• Scientific title: Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease
• Date of first enrolment: October 2010
• Target sample size: 34
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01203254
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Germany

Contacts

• Name: Florian Beigel, M.D.
• Affiliation: Klinikum der Universität München - Grosshadern

Key inclusion & exclusion criteria

Inclusion criteria:

- Signed informed consent after adequate explanation of the patient information.

- Male and female patients with CD and 18 to 65 years of age in clinical remission with
a Crohns Disease Activity Index (CDAI) score of 150 or less, with symptoms of
functional BAM or symptoms of BAM after small bowel resection with a frequency of at
least 3 to maximal 15 liquid or soft stools per day.

- Stable medical treatment of CD for a minimal period of 3 months preceding the
screening visit, consisting of

- either continuous oral treatment of aminosalicylate, prednisolone (a maximum 10
mg/day), azathioprine, 6-mercaptopurine, or methotrexate

- or supporting periodic treatment* with TNF-alpha AK (Infliximab, Adalimumab,
Certolizumab) (for patients on TNF-alpha, dosing with TNF-alpha should coincide
with baseline visit)

- Blood serum CRP value of less or equal then 1 mg/dl (10 mg/l).

- BAM assessed with a blood test on a 7a-hydroxy-4-cholesten-3-on excretion of equal or
more than 50 ng/ml

Exclusion criteria:

- Allergy or hypersensitivity to any of the components of cholestagel or placebo as
identified from the medical history

- Participation at another clinical trial within a period of 4 weeks before the
screening visit

- Presence of any addiction, alcohol abuse or specific disease that would not allow the
patient to understand the essence and requirements and potential consequences of the
participation to the clinical trial

- Signs suggestive of the patient being unable to follow the visit schedule as required
(for example for professional obligations)

- Treatment with cyclosporine, or tacrolimus, 3 month or less before screening

- Oral Treatment with antibiotics 3 weeks or less before screening

- Topical treatment with steroid- or mesalazine-containing applications 3 weeks or
less before screening

- Treatment with bile acid bile acid binding agent (e.g. Cholestayramine)6 weeks or
less before screening

- Infectious diseases (HIV, hep B, hep C, tuberculosis, listeriosis, positive
clostridium-difficile-toxin- proof in faeces)

- Current presence of intra-abdominal abscess or Fistula

- Cholestatic liver disease, bowel or biliary obstruction

- Dysphagia or swallowing disorders

- Known malignancy or history of malignancy

- Having undergone intestinal surgery within 6 months from screening

- Status after intestinal surgery with more then 100cm of resected bowel.

- Short bowel syndrome

- Planned -gastrostomy, ileostomy or colostomy.

- Pregnancy and lactation



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Crohns Disease

Bile Acid Malabsorption

Intervention(s)

Drug: Colesevelam

Drug: Placebo

Primary Outcome(s)

Reduction of fluid stool > 30 % [Time Frame: 4 weeks after baseline]

Secondary Outcome(s)

Improvement of Quality of Life. [Time Frame: 4 weeks after baseline]

Improvement of Stool Consistency [Time Frame: 4 weeks after baseline]

Change of median liquid or soft stool frequency/per day. [Time Frame: 4 weeks after baseline]

Secondary ID(s)

2009-010727-91

Source(s) of Monetary Support

Please refer to primary and secondary sponsors