Clinical trial NCT01203254: Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease
Official title: Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Crohns Disease
Bile Acid Malabsorption
Keywords: Colesevelam
IBD
Bile Acid Malabsorption
Crohns disease
Lead sponsor: Klinikum der Universitaet Muenchen, Grosshadern
Sponsor class: OTHER
First posted: 2010-09-16
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Reduction of fluid stool > 30 %
timeFrame: 4 weeks after baseline
Secondary outcomes:
measure: Improvement of Stool Consistency
timeFrame: 4 weeks after baseline
measure: Improvement of Quality of Life.
timeFrame: 4 weeks after baseline
measure: Change of median liquid or soft stool frequency/per day.
timeFrame: 4 weeks after baseline
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Praxis Dr. Mroß
city: Berlin
country: Germany
facility: Hochschulambulanz Med. Klinik I - Charite-
city: Hamburg
country: Germany
facility: Hamburgisches Forschungsinstitut für CED
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes -Innere Medizin-
city: Leipzig
country: Germany
facility: Internistische Gemeinschaftspraxis
city: Munich
country: Germany
facility: CED - Zentrum der Universität München - Klinikum Grosshadern
Study officials:
affiliation: Klinikum der Universität München - Grosshadern
name: Florian Beigel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beigel F, Teich N, Howaldt S, Lammert F, Maul J, Breiteneicher S, Rust C, Goke B, Brand S, Ochsenkuhn T. Colesevelam for the treatment of bile acid malabsorption-associated diarrhea in patients with Crohn's disease: a randomized, double-blind, placebo-controlled study. J Crohns Colitis. 2014 Nov;8(11):1471-9. doi: 10.1016/j.crohns.2014.05.009. Epub 2014 Jun 19.