Fecal IncontinencePhase 2/3FIRMNCT00727649

Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence

A Phase 2/3 study testing Psyllium powder and Loperamide in people with Fecal Incontinence, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Fecal Incontinence
What is being tested?: Psyllium powder and Loperamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteUnited States
Study dates: Jul 2008to Dec 2013
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

weekly fecal incontinence

Who cannot join

fecal impaction
inability to complete a baseline 1-week bowel diary
rectal prolapse
any prior radiation to the pelvis
colo-rectal cancer
rectal fistula

Show all 9Show fewer

inflammatory bowel disease
neurological diseases (spinal cord injury, multiple sclerosis, Parkinson's disease)
constipation (<2 bowel movements/week) or total colectomy

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Medical Center, Birmingham
Birmingham, Alabama, 35233

Other trials in United States

About this study

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

Read the detailed description

Fecal incontinence (FI) affects 4-24% adults in the community and greatly impacts quality of life. Both fiber and loperamide are common, first-line treatments for diarrhea-associated FI in primary care. No known studies exist that compare fiber and loperamide for diarrhea-predominant FI. Further knowledge is needed to define which treatment is more effective and to compare drug tolerability (side effects) for FI. This study will also look at changes in quality of life with treatment and potential mechanisms of drug treatment.

Conditions: Fecal Incontinence
Being tested: Psyllium powder, Loperamide
Keywords: fecal incontinence, adults, diarrhea
Medical subject headings: Fecal Incontinence, Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Psyllium powderDrug
Also called Metamucil
2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose)
LoperamideDrug
1 capsule daily for 28 days (weekly adjusted dose)

Study groups in NCT00727649
Study group	Role	What they receive
Arm 1	Active comparator	Fiber (psyllium) powder Receives: Drug: Psyllium powder
Arm 2	Active comparator	Loperamide Receives: Drug: Loperamide

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 4 weeks

Secondary outcomes (1)

Fecal Incontinence Severity Index Score, FISI
The patient-reported symptoms severity score, the Fecal Incontinence Severity Index (FISI), has 4 questions about the frequency of gas, mucus, liquid stool, and solid stool incontinence. Responses are weighted based on the patient rating of severity and a total score is calculated (range 0-61) with higher scores indicating a greater severity of symptoms.
Measured: baseline, 4 week and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Dec 2013

First posted4 Aug 2008 (estimated)
Study startJul 2008
Primary completionOct 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00727649
Sponsor's protocol ID: B6126-W
Acronym: FIRM
Status last verified: Mar 2015
First submitted: 29 Jul 2008
Last updated: 1 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Fecal Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence
ClinicalTrials.gov ID: NCT00727649
Acronym / sponsor ID: FIRM / B6126-W
Conditions: Fecal Incontinence
Keywords: fecal incontinence, adults, diarrhea
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: US Department of Veterans AffairsUS federal agency
Study start: Jul 2008
Primary completion: Oct 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 4 Aug 2008 (estimated)
Results: Posted 1 Apr 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Arm 1	Active comparator	Drug: Psyllium powderFiber (psyllium) powder
Arm 2	Active comparator	Drug: LoperamideLoperamide

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

weekly fecal incontinence

Key exclusion criteria (9 listed)

fecal impaction
inability to complete a baseline 1-week bowel diary
rectal prolapse
any prior radiation to the pelvis
colo-rectal cancer

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Psyllium powderAlso: Metamucil2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose)	Drug	Arm 1
Loperamide1 capsule daily for 28 days (weekly adjusted dose)	Drug	Arm 2

Primary outcome

7-day Bowel Diary, Number of Fecal Incontinence Episodes
Time frame: 6 weeks and 12 weeks
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.
Percentage of Bowel Movements With Incontinence
Time frame: 4 weeks
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.

1 secondary outcome

Fecal Incontinence Severity Index Score, FISI
Time frame: baseline, 4 week and 12 weeks

Results and safety

Results posted to the registry on 1 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
P1L2 (Psyllium First, Then Loperamide)	37	34
L1P2 (Loperamide First, Then Pysllium)	43	40

Primary outcome: 7-day Bowel Diary, Number of Fecal Incontinence Episodes

Time frame: 6 weeks and 12 weeks. Mean (Standard Deviation). Unit: Fecal incontinence episodes

Measure	P1L2 (Psyllium First, Then Loperamide) n = 34	L1P2 (Loperamide First, Then Pysllium) n = 39
Baseline	7.3 (6.2)	7.9 (7.5)
End of First Intervention	4.8 (4.8)	4.1 (5.1)
End of Wash-out Period	4.3 (4.2)	5.0 (6.2)
End of Second Intervention	3.5 (6.6)	4.7 (5.7)

Primary outcome: Percentage of Bowel Movements With Incontinence

Time frame: 4 weeks. Mean (Standard Deviation). Unit: percentage of incontinent bowel movement

Measure	P1L2 (Psyllium First, Then Loperamide) n = 34	L1P2 (Loperamide First, Then Pysllium) n = 39
Baseline	30.5 (18.0)	32.3 (23.4)
End of First Intervention	23.4 (22.1)	21.3 (22.7)
End of Wash-out Period	23.0 (22.2)	18.8 (20.2)
End of Second Intervention	15.9 (19.3)	18.8 (21.0)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: We collected adverse event data during each 4-week intervention period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
P1L2 (Psyllium First); 1st 4-weeks	0 of 34 (0%)	4 of 34 (11.8%)	Not reported
L1P2 (Loperamide First): 1st 4-weeks	0 of 40 (0%)	6 of 40 (15%)	Not reported
P1L2 (Loperamide Second); 2nd 4-weeks	1 of 29 (3.4%)	3 of 29 (10.3%)	Not reported
L1P2 (Psyllium Second); 2nd 4-weeks	0 of 34 (0%)	4 of 34 (11.8%)	Not reported

Limitations and caveats (from the sponsor): Please note that the data on those lost to follow-up limits our ability to conclude differences between the two interventions.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Fecal Incontinence

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alayne D Markland, DO MSc principal investigator

VA Medical Center, Birmingham

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Psyllium powder and Loperamide in people with Fecal Incontinence, run by US Department of Veterans Affairs at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

7-day Bowel Diary, Number of Fecal Incontinence Episodes (time frame: 6 weeks and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00727649.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.