Phase 2
N=36
Cheno Effect on Transit in Health and IBS-C
Constipation-predominant Irritable Bowel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00912301 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcome: Primary: Colonic Geometric Center at 24 Hours (GC24) — 3.1; 3.5; 2.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sodium chenodeoxycholate (NaCDC) (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Colonic Geometric Center at 24 Hours (GC24) |
3.1; 3.5; 2.2 | — |
| SECONDARY Colonic Transit at 48 Hours (GC48) |
4.1; 4.3; 3.8 | — |
| SECONDARY Ascending Colon Emptying (AC t_1/2) |
9.5; 8.2; 15.8 | — |
| SECONDARY Stool Consistency |
4.4; 4.4; 2.9 | 0.031 sig |
| SECONDARY Colonic Filling at 6 Hours |
52.6; 54.8; 50.6 | — |
Summary
The study hypothesis is that the naturally occurring bile acid, chenodeoxycholic acid, induces acceleration of colonic transit in health and in patients with constipation-predominant Irritable Bowel Syndrome (IBS-C).
Eligibility Criteria
Inclusion Criteria
Healthy volunteers:
- Age (yr) 18-65
- Gender (F:M)3.5 :1
- Bowel Disease Questionnaire (BDQ) - IBS symptoms negative by Rome III criteria
- Hospital Anxiety/Depression score 2 X Upper Limit of Normal (ULN)
- Other Medications except stable doses of estrogen, thyroid, low dose antidepressants of the dopaminergic or serotonergic class
Data sourced from ClinicalTrials.gov (NCT00912301). 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.