Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02111603
Other study ID # 14-000384
Secondary ID R01DK092179UL1TR
Status Completed
Phase Phase 4
First received April 9, 2014
Last updated January 26, 2016
Start date April 2014
Est. completion date September 2015

Study information

Verified date January 2016
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date September 2015
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

- Bowel disease questionnaire (BDQ) - IBS symptoms: Positive by Rome lll criteria

- No restrictions on Hospital Anxiety/Depression Score (HADS).

- Gender: Men or women. Women of childbearing potential will have a negative pregnancy test before initiation of medication.

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):

- Agents that alter GI transit including opioids, narcotics, anticholinergics, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors (SNRI) antidepressants.

- Analgesic drugs including opiates, nonsteroidal anti-inflammatory drugs (NSAID), cyclooxygenase-2 (COX 2) inhibitors

- Intake of medication that could interfere with the interpretation of the study.

- 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.

- Bile acid (BA) synthesis and possible false positive or negative fecal bile acid or serum 7alpha-hydroxy-4-cholesten-3-one (7alphaC4) result. If there is no AST or ALT values in the medical record, the study physicians will determine if the tests need to be run.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Colesevelam
Subjects will receive 1875 mg of Colesevelam orally twice daily for 10 days

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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):4 — View Citation

Outcome

Type Measure Description Time frame Safety issue
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. baseline, 10 days No
Secondary Change in Fasting Serum C4 Change in fasting serum C4 from baseline in response to treatment with colesevelam. baseline, 10 days No
Secondary Change in Fecal Fat Excretion Change in fecal fat excretion from baseline in response to treatment with colesevelam baseline, 10 days No
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. baseline, 10 days No
Secondary Change in Stool Frequency (Number of Stools Per Week) Change in stool frequency from baseline in response to treatment with colesevelam. baseline, 10 days No
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.
baseline, 10 days No
See also
  Status Clinical Trial Phase
Completed NCT02251483 - Use of SBI in IBS Subjects Following a Successful Treatment of Small Intestinal Bacterial Overgrowth N/A
Terminated NCT02239926 - Effect of Ranolazine on Gastrointestinal Motor Function and Pain in Patients With IBS-D Phase 2/Phase 3
Completed NCT01896583 - A Phase 2 Pilot Study to Assess ASP7147 in Patients With Diarrhea Predominant Irritable Bowel Syndrome (IBS-D) Phase 2
Completed NCT01100684 - Study of Asimadoline to Treat Diarrhea-Predominant Irritable Bowel Syndrome (D-IBS) Phase 3
Completed NCT02728063 - Lactibiane Tolérance® in Individuals Suffering From Irritable Bowel Syndrome With Diarrheal Predominance N/A
Completed NCT02358694 - Safety and Tolerability of Serum Derived Bovine Immunoglobulin in Children With Diarrhea Predominant IBS N/A
Recruiting NCT01637714 - The Effects of Multi-strain Probiotics in Adults With Diarrhea Predominant Irritable Bowel Syndrome N/A
Not yet recruiting NCT01373034 - The Effects of Soy Dietary Fiber in Adults With Diarrhea Predominant Irritable Bowel Syndrome N/A
Completed NCT01094041 - Gluten Intolerance in Patients With Diarrhea Predominant Irritable Bowel Syndrome N/A
Completed NCT00616200 - Effects of a Very Low Carbohydrate Diet on Symptoms of Irritable Bowel Syndrome (IBS) N/A