Does Welchol (Colesevelam Hydrochloride) Improve Colonic Transit in Diarrhea-predominant Irritable Bowel Syndrome (D-IBS)? (welchol)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00911612
First received: May 29, 2009
Last updated: March 29, 2012
Last verified: March 2012
Results First Received: February 10, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Irritable Bowel Syndrome
Diarrhea
Interventions: Drug: Colesevelam
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All participants were recruited from the Mayo Clinic in Rochester, Minnesota from January through May 2009. 31 subjects signed consent, 1 withdrew consent before the start of the study, 2 had concomitant illness and 4 did not qualify based on colon transit eligibility criteria. 24 subjects were randomized and were included in the analysis.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Colesevelam Participants received colesevelam 1.875 g twice daily
Placebo Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy

Participant Flow:   Overall Study
    Colesevelam     Placebo  
STARTED     12     12  
COMPLETED     12     12  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Colesevelam Participants received colesevelam 1.875 g twice daily
Placebo Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
Total Total of all reporting groups

Baseline Measures
    Colesevelam     Placebo     Total  
Number of Participants  
[units: participants]
  12     12     24  
Age  
[units: years]
Mean ± Standard Deviation
  42.1  ± 4.0     43.3  ± 3.7     42.8  ± 13.0  
Gender  
[units: participants]
     
Female     12     12     24  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     12     12     24  
Body Mass Index  
[units: kg/m^2]
Mean ± Standard Deviation
  31.8  ± 1.5     28.9  ± 1.8     30.4  ± 5.7  
Baseline Colonic Geometric Center at 24 hours [1]
[units: units on a scale]
Mean ± Standard Deviation
  3.4  ± 0.3     3.4  ± 0.3     3.4  ± 0.2  
Fasting Serum 7 alpha-HCO [2]
[units: ng/mL]
Mean ± Standard Deviation
  31.8  ± 5.9     38.2  ± 14.7     35.0  ± 36.5  
[1] The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
[2] The measurement of serum 7 alpha-hydroxy-4-cholesten-3-one (7 alpha-HCO) is a measurement of hepatic cholesterol synthesis, is closely related to the fecal loss of bile acids, and is a validated method for screening for bile acid malabsorption (BAM).



  Outcome Measures
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1.  Primary:   Colonic Transit, Geometric Center at 24 Hours   [ Time Frame: After 12-14 days treatment ]

2.  Primary:   Ascending Colon Emptying T1/2   [ Time Frame: After 12-14 days' treatment ]

3.  Secondary:   Colonic Permeability as Measured by Cumulative Urinary Excretion of Mannitol 8-24 Hours   [ Time Frame: after 12-14 days' treatment ]

4.  Secondary:   Colonic Transit, Geometric Center at 48 Hours   [ Time Frame: After 12-14 days' treatment ]

5.  Secondary:   Stool Consistency   [ Time Frame: After 12-14 days' treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Michael Camilleri
Organization: Mayo Clinic
phone: 507-266-2306
e-mail: camilleri.michael@mayo.edu


Publications of Results:
Other Publications:

Responsible Party: Michael Camilleri, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00911612     History of Changes
Other Study ID Numbers: 08-007454, R01DK054681
Study First Received: May 29, 2009
Results First Received: February 10, 2012
Last Updated: March 29, 2012
Health Authority: United States: Institutional Review Board