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Alpha-2 Adrenergic Agonist

Colesevelam and Clonidine for Bowel Incontinence

Phase 3
Waitlist Available
Led By Adil Bharucha, MBBS, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study Summary

This study is evaluating whether a combination of colesevelam and clonidine is more effective than placebo in reducing bowel symptoms in patients with urge or combined type of FI.

Eligible Conditions
  • Bile Acid Malabsorption
  • Bowel Incontinence

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants to Report a 50% or Greater Reduction in Weekly Fecal Incontinence (FI) Episodes
Secondary outcome measures
Daily Stool Frequency
Delay of Bowel Movement
Fecal Incontinence Quality of Life (FI-QoL)
+11 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Colesevelam and ClonidineActive Control2 Interventions
Participants in this arm will receive a combination of colesevelam (1.875 gm twice daily) and clonidine (0.1 mg oral twice daily) for 4 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants in this arm will receive placebo for 4 weeks.

Find a Location

Who is running the clinical trial?

National Center for Research Resources (NCRR)NIH
537 Previous Clinical Trials
316,928 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,204 Previous Clinical Trials
3,768,010 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,356 Previous Clinical Trials
4,314,982 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of Colesevelam in Fecal Incontinence
Adil Bharucha, MBBS, MD 2015. "A Study of Colesevelam in Fecal Incontinence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02628626.
~9 spots leftby Apr 2025
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