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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK092179 | U.S. NIH Grant/Contract | View source | |
| UL1TR000135 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The investigators' hypothesis is that therapy with Colesevelam, reduces fecal bile acid excretion in patients with Irritable Bowel Syndrome (IBS)-diarrhea with prior evidence of increased fecal 48 hour total bile acid excretion. The investigators aim to study the ability of the HPLC assay for fecal bile acids to demonstrate responsiveness after treatment with Colesevelam.
This study will evaluate whether Colesevelam, a bile acid sequestrant, is able to reduce fecal bile acids and improve bowel function in patients with IBS-diarrhea and Mayo's HPLC method can demonstrate a response to the Colesevelam.
The study design will be a single center, unblinded, single dose trial to study the ability to identify the effect of taking 1875 mg (3 tablets [625 mg/tablet]) of Colesevelam orally twice daily for ten days on fasting serum 7alphaC4 and total 48 hour fecal bile acid excretion. Stool and fasting serum samples will be collected predose and during final 48 hours' dosing for assessment. Participants will also fill out an 8-day stool diary assessing frequency, consistency, ease of passage of bowel movements before and during treatment with Colesevelam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colesevelam | Other | 1875 mg of Colesevelam orally twice daily for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colesevelam | Drug | Subjects will receive 1875 mg of Colesevelam orally twice daily for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total 48 Hour Fecal Bile Acids (BA) From Baseline in Response to Treatment With Colesevelam | Stool 48 hour collections (for BAs) were collected during baseline before treatment, and then during days 9-10 of the 10 days of colesevelam dosing for fecal BAs. Total fecal BA were measured using HPLC/tandem mass spectrometry. | baseline, 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Serum C4 | Change in fasting serum C4 from baseline in response to treatment with colesevelam. | baseline, 10 days |
| Change in Fecal Fat Excretion | Change in fecal fat excretion from baseline in response to treatment with colesevelam |
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Patients with IBS-diarrhea with prior evidence of increased fecal 48 hour total bile acid and increased fasting serum 7alphaC4 who meet the following:
INCLUSION CRITERIA
EXCLUSION CRITERIA
Use of drugs or agents within the past 1 week or planned use in the subsequent 2 weeks during the study period (Birth control pill, estrogen replacement therapy, and thyroxine replacement are permissible exceptions):
Female subjects who are pregnant or breast-feeding. Females must be either surgically sterilized, postmenopausal (>12 months since last menses), or, if of childbearing potential, using reliable methods of contraception as determined by the physician.
Abdominal surgery (except Appendectomy)
Patients with known chronic liver disease or history of elevated aspartate aminotransferase (AST)/ alanine transaminase (ALT) 2.0 X upper limit of normal.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Camilleri, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25594801 | Result | Camilleri M, Acosta A, Busciglio I, Boldingh A, Dyer RB, Zinsmeister AR, Lueke A, Gray A, Donato LJ. Effect of colesevelam on faecal bile acids and bowel functions in diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2015 Mar;41(5):438-48. doi: 10.1111/apt.13065. Epub 2015 Jan 16. |
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Data already published in PMID: 25594801
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13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities.
Participants were recruited from the Mayo Clinic in Rochester, Minnesota.
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| ID | Title | Description |
|---|---|---|
| FG000 | Colesevelam | 1875 mg of Colesevelam orally twice daily for 10 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities.
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| ID | Title | Description |
|---|---|---|
| BG000 | Colesevelam | 1875 mg of Colesevelam orally twice daily for 10 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Total 48 Hour Fecal Bile Acids (BA) From Baseline in Response to Treatment With Colesevelam | Stool 48 hour collections (for BAs) were collected during baseline before treatment, and then during days 9-10 of the 10 days of colesevelam dosing for fecal BAs. Total fecal BA were measured using HPLC/tandem mass spectrometry. | 13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure. | Posted | Mean | Standard Error | uM | baseline, 10 days |
|
Participants were followed for adverse events for the 10 days they were on study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Colesevelam | 1875 mg of Colesevelam orally twice daily for 10 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Camilleri | Mayo Clinic | 507-284-6218 | camilleri.michael@mayo.edu |
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| ID | Term |
|---|---|
| D000069472 | Colesevelam Hydrochloride |
| ID | Term |
|---|---|
| D000499 | Allylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000498 | Allyl Compounds |
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| baseline, 10 days |
| Change in Stool Consistency | The subjects rated their stool consistency using the Bristol Stool Form Scale. The Bristol Stool Form 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. | baseline, 10 days |
| Change in Stool Frequency (Number of Stools Per Week) | Change in stool frequency from baseline in response to treatment with colesevelam. | baseline, 10 days |
| Concordance Correlation Coefficients of the Relative Composition of Stool Total and the Main Individual Bile Acids (BA) | Stool 48 hour collections (for BAs) were collected during baseline before treatment, and then during days 9-10 of the 10 days of colesevelam dosing for fecal BAs. Relative composition of the main individual bile acids (cholic acid (CA), chenodeoxycholic acid (CDCA), deoxycholic acid (DCA), lithocholic acid (LCA) and ursodeoxycholic acid (UDCA)) in 48 hour stool collection after colesevelam treatment were compared to baseline values. The concordance correlation coefficient (rc) measures agreement between two variables. The concordance correlation satisfies -1 ≤ rc ≤ +1. A value of rc = +1 corresponds to perfect agreement. A value of rc = -1 corresponds to perfect negative agreement, and a value of rc = 0 corresponds to no agreement. | baseline, 10 days |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Mean Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Change in Fasting Serum C4 | Change in fasting serum C4 from baseline in response to treatment with colesevelam. | 13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure. | Posted | Mean | Standard Error | ng/mL | baseline, 10 days |
|
|
|
| Secondary | Change in Fecal Fat Excretion | Change in fecal fat excretion from baseline in response to treatment with colesevelam | 13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure. | Posted | Mean | Standard Error | g/day | baseline, 10 days |
|
|
|
| Secondary | Change in Stool Consistency | The subjects rated their stool consistency using the Bristol Stool Form Scale. The Bristol Stool Form 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. | 13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure. | Posted | Mean | Standard Error | units on a scale | baseline, 10 days |
|
|
|
| Secondary | Change in Stool Frequency (Number of Stools Per Week) | Change in stool frequency from baseline in response to treatment with colesevelam. | 13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure. | Posted | Mean | Standard Error | Number of stools per week | baseline, 10 days |
|
|
|
| Secondary | Concordance Correlation Coefficients of the Relative Composition of Stool Total and the Main Individual Bile Acids (BA) | Stool 48 hour collections (for BAs) were collected during baseline before treatment, and then during days 9-10 of the 10 days of colesevelam dosing for fecal BAs. Relative composition of the main individual bile acids (cholic acid (CA), chenodeoxycholic acid (CDCA), deoxycholic acid (DCA), lithocholic acid (LCA) and ursodeoxycholic acid (UDCA)) in 48 hour stool collection after colesevelam treatment were compared to baseline values. The concordance correlation coefficient (rc) measures agreement between two variables. The concordance correlation satisfies -1 ≤ rc ≤ +1. A value of rc = +1 corresponds to perfect agreement. A value of rc = -1 corresponds to perfect negative agreement, and a value of rc = 0 corresponds to no agreement. | 13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure. | Posted | Mean | Standard Error | concordance correlation coefficient | baseline, 10 days |
|
|
|
| 0 |
| 12 |
| 2 |
| 12 |
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| D000475 |
| Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| Title | Measurements |
|---|---|
|
| CA 48 hour collection after colesevelam |
|
| DCA at Baseline |
|
| DCA 48 hour collection after colesevelam |
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| UDCA at Baseline |
|
| UDCA 48 hour collection after colesevelam |
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| CDCA at Baseline |
|
| CDCA 48 hour collection after colesevelam |
|
| LCA at Baseline |
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| LCA 48 hour collection after colesevelam |
|