Phase 4
N=13
Ability of Mayo Clinic High-performance Liquid Chromatography (HPLC) Method to Measure Fecal Bile Acids
Diarrhea Predominant Irritable Bowel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02111603 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Change in Total 48 Hour Fecal Bile Acids (BA) From Baseline in Response to Treatment With Colesevelam — 1662; 3496 uM — p=0.012
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Colesevelam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total 48 Hour Fecal Bile Acids (BA) From Baseline in Response to Treatment With Colesevelam |
1662; 3496 | 0.012 sig |
| SECONDARY Change in Fasting Serum C4 |
24.7; 72.3 | — |
| SECONDARY Change in Fecal Fat Excretion |
6.4; 6.8 | — |
| SECONDARY Change in Stool Consistency |
4.8; 4.4 | — |
| SECONDARY Change in Stool Frequency (Number of Stools Per Week) |
17.6; 15.1 | — |
| SECONDARY Concordance Correlation Coefficients of the Relative Composition of Stool Total and the Main Individual Bile Acids (BA) |
0.53; 0.54; 0.84; 0.83; 0.68; 0.85 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02111603). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.