NCT00727649

Brief Summary

The purpose of this study is to evaluate and compare treatment with fiber and loperamide for fecal incontinence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 4, 2008

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 1, 2015

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

5.3 years

First QC Date

July 29, 2008

Results QC Date

January 23, 2015

Last Update Submit

March 18, 2015

Conditions

Fecal Incontinence

Keywords

fecal incontinenceadultsdiarrhea

Outcome Measures

Primary Outcomes (2)

  • 7-day Bowel Diary, Number of Fecal Incontinence Episodes

    After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). The mean number of total fecal incontinence episodes from a 7-day bowel diary from each time point was compared between the groups.

    6 weeks and 12 weeks

  • Percentage of Bowel Movements With Incontinence

    After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). We compared the percentage of the total number of fecal incontinence episodes over the total number of bowel movements from a 7-day bowel diary from each time point between the groups.

    4 weeks

Secondary Outcomes (1)

  • Fecal Incontinence Severity Index Score, FISI

    baseline, 4 week and 12 weeks

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Fiber (psyllium) powder

Drug: Psyllium powder

Arm 2

ACTIVE COMPARATOR

Loperamide

Drug: Loperamide

Interventions

Psyllium powderDRUG

2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose)

Also known as: Metamucil
Arm 1
LoperamideDRUG

1 capsule daily for 28 days (weekly adjusted dose)

Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • weekly fecal incontinence

You may not qualify if:

  • fecal impaction
  • inability to complete a baseline 1-week bowel diary
  • rectal prolapse
  • any prior radiation to the pelvis
  • colo-rectal cancer
  • rectal fistula
  • inflammatory bowel disease
  • neurological diseases (spinal cord injury, multiple sclerosis, Parkinson's disease)
  • constipation (\<2 bowel movements/week) or total colectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Fecal IncontinenceDiarrhea

Interventions

PsylliumLoperamide

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex MixturesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

Please note that the data on those lost to follow-up limits our ability to conclude differences between the two interventions.

Results Point of Contact

Title
Dr. Alayne Markland, PI of this clinical trial
Organization
Birmingham VA Medical Center
alayne.markland@va.gov
205-933-8101

Study Officials

  • Alayne D Markland, DO MSc

    VA Medical Center, Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2008

First Posted

August 4, 2008

Study Start

July 1, 2008

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

April 1, 2015

Results First Posted

April 1, 2015

Record last verified: 2015-03

Locations

US(1)