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Cheno Effect on Transit in Health and IBS-C (Chenotransit)

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ClinicalTrials.gov Identifier: NCT00912301
Recruitment Status : Completed
First Posted : June 3, 2009
Results First Posted : July 2, 2012
Last Update Posted : July 2, 2012
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Information provided by:
Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Constipation-predominant Irritable Bowel Syndrome
Interventions Drug: Sodium chenodeoxycholate (NaCDC)
Other: Placebo
Enrollment 36
Recruitment Details Participants were enrolled between April 17 and November 20, 2009 from 150 mile geographical area around Mayo Clinic, Rochester, MN.
Pre-assignment Details 40 patients signed informed consent, but 3 failed screening due to presence of evacuation disorder, and 1 withdrew prior to study due to illness.
Arm/Group Title NaCDC 500 mg NaCDC 1000 mg Placebo
Hide Arm/Group Description Participants randomized to this arm received 500 mg NaCDC per day for 4 days. Participants randomized to this arm received 1000 mg NaCDC per day for 4 days. Participants randomized to this arm received a placebo capsule each day for 4 days.
Period Title: Overall Study
Started 11 12 13
Completed 11 12 13
Not Completed 0 0 0
Arm/Group Title NaCDC 500 mg NaCDC 1000 mg Placebo Total
Hide Arm/Group Description Participants randomized to this arm received 500 mg NaCDC per day for 4 days. Participants randomized to this arm received 1000 mg NaCDC per day for 4 days. Participants randomized to this arm received a placebo capsule each day for 4 days. Total of all reporting groups
Overall Number of Baseline Participants 11 12 13 36
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 12 participants 13 participants 36 participants
38.3  (3.3) 46.1  (2.6) 40.8  (2.3) 42  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 13 participants 36 participants
Female
11
 100.0%
12
 100.0%
13
 100.0%
36
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 12 participants 13 participants 36 participants
11 12 13 36
1.Primary Outcome
Title Colonic Geometric Center at 24 Hours (GC24)
Hide Description 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.
Time Frame after 4 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NaCDC 500 mg NaCDC 1000 mg Placebo
Hide Arm/Group Description:
Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
Participants randomized to this arm received a placebo capsule each day for 4 days.
Overall Number of Participants Analyzed 11 12 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.1  (0.4) 3.5  (0.4) 2.2  (0.2)
2.Secondary Outcome
Title Colonic Transit at 48 Hours (GC48)
Hide Description 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.
Time Frame after 4 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NaCDC 500 mg NaCDC 1000 mg Placebo
Hide Arm/Group Description:
Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
Participants randomized to this arm received a placebo capsule each day for 4 days.
Overall Number of Participants Analyzed 11 12 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.1  (0.3) 4.3  (0.3) 3.8  (0.3)
3.Secondary Outcome
Title Ascending Colon Emptying (AC t_1/2)
Hide Description [Not Specified]
Time Frame after 4 days' treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NaCDC 500 mg NaCDC 1000 mg Placebo
Hide Arm/Group Description:
Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
Participants randomized to this arm received a placebo capsule each day for 4 days.
Overall Number of Participants Analyzed 11 12 13
Mean (Standard Deviation)
Unit of Measure: hours
9.5  (2.9) 8.2  (1.8) 15.8  (2.5)
4.Secondary Outcome
Title Stool Consistency
Hide Description The subjects rated their stool consistency using the Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the "ideal stools" especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea.
Time Frame after 4 days' treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NaCDC 500 mg NaCDC 1000 mg Placebo
Hide Arm/Group Description:
Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
Participants randomized to this arm received a placebo capsule each day for 4 days.
Overall Number of Participants Analyzed 11 12 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.4  (0.5) 4.4  (0.4) 2.9  (0.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaCDC 500 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments [Not Specified]
Method Dunnett's test
Comments pairwise comparison low dose NaCDC against placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NaCDC 1000 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Dunnett's test
Comments pairwise comparison high dose NaCDC against placebo
5.Secondary Outcome
Title Colonic Filling at 6 Hours
Hide Description Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.
Time Frame after 4 days' treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NaCDC 500 mg NaCDC 1000 mg Placebo
Hide Arm/Group Description:
Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
Participants randomized to this arm received a placebo capsule each day for 4 days.
Overall Number of Participants Analyzed 11 12 13
Mean (Standard Deviation)
Unit of Measure: percentage of the radio-labeled meal
52.6  (6.7) 54.8  (7.1) 50.6  (6.7)
Time Frame Adverse events were collected during the 4 days of the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NaCDC 500 mg NaCDC 1000 mg Placebo
Hide Arm/Group Description Participants randomized to this arm received 500 mg NaCDC per day for 4 days. Participants randomized to this arm received 1000 mg NaCDC per day for 4 days. Participants randomized to this arm received a placebo capsule each day for 4 days.
All-Cause Mortality
NaCDC 500 mg NaCDC 1000 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
NaCDC 500 mg NaCDC 1000 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/12 (0.00%)      0/12 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NaCDC 500 mg NaCDC 1000 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/11 (54.55%)      8/12 (66.67%)      2/13 (15.38%)    
Gastrointestinal disorders       
Lower abdominal cramping/pain *  5/11 (45.45%)  5 5/12 (41.67%)  5 0/13 (0.00%)  0
Diarrhea *  2/11 (18.18%)  2 2/12 (16.67%)  2 0/13 (0.00%)  0
Nausea *  1/11 (9.09%)  1 3/12 (25.00%)  3 0/13 (0.00%)  0
Gas *  1/11 (9.09%)  1 2/12 (16.67%)  2 0/13 (0.00%)  0
Heartburn *  2/11 (18.18%)  2 0/12 (0.00%)  0 0/13 (0.00%)  0
General disorders       
Headache *  2/11 (18.18%)  2 2/12 (16.67%)  2 2/13 (15.38%)  2
Light-headedness *  1/11 (9.09%)  1 2/12 (16.67%)  2 0/13 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael L. Camilleri, MD
Organization: Mayo Clinic
Phone: 507-266-2306
EMail: camilleri.michael@mayo.edu
Publications of Results:
Rao AS, Wong BS, Camilleri M, Odunsi-Shiyanbade ST, McKinzie S, Ryks M, Burton D, Carlson P, Lamsam J, Singh R, Zinsmeister AR. Chenodeoxycholate in females with irritable bowel syndrome-constipation: a pharmacodynamic and pharmacogenetic analysis. Gastroenterology. 2010 Nov;139(5):1549-58, 1558.e1. doi: 10.1053/j.gastro.2010.07.052. Epub 2010 Aug 4.
Other Publications:
Layout table for additonal information
Responsible Party: Michael Camilleri, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00912301    
Other Study ID Numbers: 08-001003
R01DK054681 ( U.S. NIH Grant/Contract )
R01DK079866 ( U.S. NIH Grant/Contract )
UL1RR024150 ( U.S. NIH Grant/Contract )
1RC1DK086182 ( U.S. NIH Grant/Contract )
First Submitted: May 29, 2009
First Posted: June 3, 2009
Results First Submitted: May 29, 2012
Results First Posted: July 2, 2012
Last Update Posted: July 2, 2012