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

This study has been terminated.
(insufficient enrollment)
Sponsor:
Information provided by (Responsible Party):
Florian Beigel, Klinikum der Universitaet Muenchen, Grosshadern
ClinicalTrials.gov Identifier:
NCT01203254
First received: September 15, 2010
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to assess the efficacy of cholestagel to reduce the frequency of soft and liquid stools per day in patients with CD in clinical remission with symptoms of BAM and to assess the improvement in stool consistency and quality of life in these patients and to assess the safety of cholestagel.


Condition Intervention Phase
Crohns Disease
Bile Acid Malabsorption
Drug: Colesevelam
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Klinikum der Universitaet Muenchen, Grosshadern:

Primary Outcome Measures:
  • Reduction of fluid stool > 30 % [ Time Frame: 4 weeks after baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of Stool Consistency [ Time Frame: 4 weeks after baseline ] [ Designated as safety issue: No ]
    Proportion of patients on cholestagel compared to placebo that reaches improvement of stool consistency on the Bristol stool chart of at least one point.

  • Improvement of Quality of Life. [ Time Frame: 4 weeks after baseline ] [ Designated as safety issue: No ]
    Proportion of patients on cholestagel compared to placebo that reaches an improvement of the Quality of Life.

  • Change of median liquid or soft stool frequency/per day. [ Time Frame: 4 weeks after baseline ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: October 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo tablet: 3 times daily 2 tablets
Active Comparator: Cholestagel Drug: Colesevelam
Colesevelam 625 mg tablet; 3 times daily 2 tablets

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 7α-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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203254

Locations
Germany
Hochschulambulanz Med. Klinik I - Charite-
Berlin, Germany, 12200
Praxis Dr. Mroß
Berlin, Germany, 10318
Hamburgisches Forschungsinstitut für CED
Hamburg, Germany, 20148
Universitätsklinikum des Saarlandes -Innere Medizin-
Homburg, Germany, 66424
Internistische Gemeinschaftspraxis
Leipzig, Germany, 04105
CED - Zentrum der Universität München - Klinikum Grosshadern
Munich, Germany, 81377
Sponsors and Collaborators
Florian Beigel
Investigators
Principal Investigator: Florian Beigel, M.D. Klinikum der Universität München - Grosshadern
  More Information

No publications provided

Responsible Party: Florian Beigel, Dr. med., Klinikum der Universitaet Muenchen, Grosshadern
ClinicalTrials.gov Identifier: NCT01203254     History of Changes
Other Study ID Numbers: 2009-010727-91
Study First Received: September 15, 2010
Last Updated: April 17, 2013
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Klinikum der Universitaet Muenchen, Grosshadern:
Colesevelam
IBD
Bile Acid Malabsorption
Crohns disease

Additional relevant MeSH terms:
Crohn Disease
Malabsorption Syndromes
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Metabolic Diseases
Bile Acids and Salts
Colesevelam
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on August 21, 2014