Ability of Mayo Clinic High-performance Liquid Chromatography (HPLC) Method to Measure Fecal Bile Acids

NCT02111603 | Completed Phase 4 Results

• 3 other identifiers: 14-000384R01DK092179UL1TR000135
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diarrhea Predominant Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Change in Fasting Serum C4

  baseline, 10 days

• Change in Fecal Fat Excretion

  baseline, 10 days

• Change in Stool Consistency

  baseline, 10 days

• Change in Stool Frequency (Number of Stools Per Week)

  baseline, 10 days

• Concordance Correlation Coefficients of the Relative Composition of Stool Total and the Main Individual Bile Acids (BA)

  baseline, 10 days

Study Arms (1)

Colesevelam

OTHER

1875 mg of Colesevelam orally twice daily for 10 days

Drug: Colesevelam

Interventions

Colesevelam DRUG

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

Also known as: Welchol

Colesevelam

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related 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):438-48. doi: 10.1111/apt.13065. Epub 2015 Jan 16.

  PMID: 25594801 RESULT

MeSH Terms

Interventions

Colesevelam Hydrochloride

Intervention Hierarchy (Ancestors)

Allylamine; Amines; Organic Chemicals; Allyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons

Results Point of Contact

• Title: Dr. Michael Camilleri
• Organization: Mayo Clinic

camilleri.michael@mayo.edu

507-284-6218

Study Officials

• Michael Camilleri, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 11, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2015
• Last Updated: May 12, 2016
• Results First Posted: January 27, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)