Trial Outcomes & Findings for Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence (NCT NCT00727649)
NCT ID: NCT00727649
Last Updated: 2015-04-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
80 participants
Primary outcome timeframe
6 weeks and 12 weeks
Results posted on
2015-04-01
Participant Flow
Outpatient medical clinic
Participant milestones
| Measure |
P1L2 (Psyllium First, Then Loperamide)
Fiber (psyllium) powder with loperamide placebo first
Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy
|
L1P2 (Loperamide First, Then Pysllium)
Fiber (psyllium) powder placebo with loperamide 2mg
Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy
|
|---|---|---|
|
First Intervention (4-weeks)
STARTED
|
37
|
43
|
|
First Intervention (4-weeks)
COMPLETED
|
34
|
40
|
|
First Intervention (4-weeks)
NOT COMPLETED
|
3
|
3
|
|
Wash-out (2-weeks)
STARTED
|
34
|
40
|
|
Wash-out (2-weeks)
COMPLETED
|
30
|
37
|
|
Wash-out (2-weeks)
NOT COMPLETED
|
4
|
3
|
|
Second Intervention (4-weeks)
STARTED
|
30
|
37
|
|
Second Intervention (4-weeks)
COMPLETED
|
29
|
34
|
|
Second Intervention (4-weeks)
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
P1L2 (Psyllium First, Then Loperamide)
Fiber (psyllium) powder with loperamide placebo first
Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy
|
L1P2 (Loperamide First, Then Pysllium)
Fiber (psyllium) powder placebo with loperamide 2mg
Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy
|
|---|---|---|
|
First Intervention (4-weeks)
Lost to Follow-up
|
1
|
2
|
|
First Intervention (4-weeks)
Withdrawal by Subject
|
2
|
1
|
|
Wash-out (2-weeks)
Lost to Follow-up
|
3
|
1
|
|
Wash-out (2-weeks)
Withdrawal by Subject
|
1
|
2
|
|
Second Intervention (4-weeks)
Death
|
1
|
0
|
|
Second Intervention (4-weeks)
Lost to Follow-up
|
0
|
1
|
|
Second Intervention (4-weeks)
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence
Baseline characteristics by cohort
| Measure |
P1L2 (Psyllium First, Then Loperamide)
n=37 Participants
Fiber (psyllium) powder with loperamide placebo first
Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 2 mg placebo daily with weekly dose adjustments for side-effects and/or efficacy
|
L1P2 (Loperamide First, Then Pysllium)
n=43 Participants
Fiber (psyllium) powder placebo with loperamide 2mg pill
Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 10.9 • n=93 Participants
|
59.2 years
STANDARD_DEVIATION 9.2 • n=4 Participants
|
60.8 years
STANDARD_DEVIATION 10.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=93 Participants
|
43 participants
n=4 Participants
|
80 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 weeks and 12 weeksAfter 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.
Outcome measures
| Measure |
P1L2 (Psyllium First, Then Loperamide)
n=34 Participants
Fiber (psyllium) powder with loperamide placebo first
Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy
|
L1P2 (Loperamide First, Then Pysllium)
n=39 Participants
Fiber (psyllium) powder placebo with loperamide 2mg
Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy
|
|---|---|---|
|
7-day Bowel Diary, Number of Fecal Incontinence Episodes
Baseline
|
7.3 Fecal incontinence episodes
Standard Deviation 6.2
|
7.9 Fecal incontinence episodes
Standard Deviation 7.5
|
|
7-day Bowel Diary, Number of Fecal Incontinence Episodes
End of First Intervention
|
4.8 Fecal incontinence episodes
Standard Deviation 4.8
|
4.1 Fecal incontinence episodes
Standard Deviation 5.1
|
|
7-day Bowel Diary, Number of Fecal Incontinence Episodes
End of Wash-out Period
|
4.3 Fecal incontinence episodes
Standard Deviation 4.2
|
5.0 Fecal incontinence episodes
Standard Deviation 6.2
|
|
7-day Bowel Diary, Number of Fecal Incontinence Episodes
End of Second Intervention
|
3.5 Fecal incontinence episodes
Standard Deviation 6.6
|
4.7 Fecal incontinence episodes
Standard Deviation 5.7
|
PRIMARY outcome
Timeframe: 4 weeksAfter 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.
Outcome measures
| Measure |
P1L2 (Psyllium First, Then Loperamide)
n=34 Participants
Fiber (psyllium) powder with loperamide placebo first
Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy
|
L1P2 (Loperamide First, Then Pysllium)
n=39 Participants
Fiber (psyllium) powder placebo with loperamide 2mg
Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy
|
|---|---|---|
|
Percentage of Bowel Movements With Incontinence
Baseline
|
30.5 percentage of incontinent bowel movement
Standard Deviation 18.0
|
32.3 percentage of incontinent bowel movement
Standard Deviation 23.4
|
|
Percentage of Bowel Movements With Incontinence
End of First Intervention
|
23.4 percentage of incontinent bowel movement
Standard Deviation 22.1
|
21.3 percentage of incontinent bowel movement
Standard Deviation 22.7
|
|
Percentage of Bowel Movements With Incontinence
End of Wash-out Period
|
23.0 percentage of incontinent bowel movement
Standard Deviation 22.2
|
18.8 percentage of incontinent bowel movement
Standard Deviation 20.2
|
|
Percentage of Bowel Movements With Incontinence
End of Second Intervention
|
15.9 percentage of incontinent bowel movement
Standard Deviation 19.3
|
18.8 percentage of incontinent bowel movement
Standard Deviation 21.0
|
SECONDARY outcome
Timeframe: baseline, 4 week and 12 weeksThe 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.
Outcome measures
| Measure |
P1L2 (Psyllium First, Then Loperamide)
n=36 Participants
Fiber (psyllium) powder with loperamide placebo first
Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy
|
L1P2 (Loperamide First, Then Pysllium)
n=42 Participants
Fiber (psyllium) powder placebo with loperamide 2mg
Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy
|
|---|---|---|
|
Fecal Incontinence Severity Index Score, FISI
Baseline
|
29.1 units on a scale
Standard Deviation 11.0
|
31.9 units on a scale
Standard Deviation 13.5
|
|
Fecal Incontinence Severity Index Score, FISI
End of First Intervention
|
24.9 units on a scale
Standard Deviation 12.2
|
24.9 units on a scale
Standard Deviation 13.3
|
|
Fecal Incontinence Severity Index Score, FISI
End of Second Intervention
|
22.0 units on a scale
Standard Deviation 17.1
|
23.2 units on a scale
Standard Deviation 12.7
|
Adverse Events
P1L2 (Psyllium First); 1st 4-weeks
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
L1P2 (Loperamide First): 1st 4-weeks
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
P1L2 (Loperamide Second); 2nd 4-weeks
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
L1P2 (Psyllium Second); 2nd 4-weeks
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
P1L2 (Psyllium First); 1st 4-weeks
n=34 participants at risk
Fiber (psyllium) powder with loperamide placebo first
Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy
|
L1P2 (Loperamide First): 1st 4-weeks
n=40 participants at risk
Fiber (psyllium) powder placebo with loperamide 2mg
Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy
|
P1L2 (Loperamide Second); 2nd 4-weeks
n=29 participants at risk
Fiber (psyllium) powder placebo with loperamide 2mg
Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy
|
L1P2 (Psyllium Second); 2nd 4-weeks
n=34 participants at risk
Fiber (psyllium) powder with loperamide placebo first
Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy
|
|---|---|---|---|---|
|
Gastrointestinal disorders
death
|
0.00%
0/34 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
0.00%
0/40 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
3.4%
1/29 • Number of events 1 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
0.00%
0/34 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
Other adverse events
| Measure |
P1L2 (Psyllium First); 1st 4-weeks
n=34 participants at risk
Fiber (psyllium) powder with loperamide placebo first
Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy
|
L1P2 (Loperamide First): 1st 4-weeks
n=40 participants at risk
Fiber (psyllium) powder placebo with loperamide 2mg
Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy
|
P1L2 (Loperamide Second); 2nd 4-weeks
n=29 participants at risk
Fiber (psyllium) powder placebo with loperamide 2mg
Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy
|
L1P2 (Psyllium Second); 2nd 4-weeks
n=34 participants at risk
Fiber (psyllium) powder with loperamide placebo first
Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy
|
|---|---|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
8.8%
3/34 • Number of events 3 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
15.0%
6/40 • Number of events 6 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
10.3%
3/29 • Number of events 3 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
5.9%
2/34 • Number of events 2 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
|
Gastrointestinal disorders
constipation
|
8.8%
3/34 • Number of events 3 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
10.0%
4/40 • Number of events 4 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
10.3%
3/29 • Number of events 3 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
8.8%
3/34 • Number of events 3 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
|
Gastrointestinal disorders
diarrhea
|
5.9%
2/34 • Number of events 2 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
15.0%
6/40 • Number of events 6 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
6.9%
2/29 • Number of events 2 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
11.8%
4/34 • Number of events 4 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
|
Gastrointestinal disorders
excessive flatus
|
11.8%
4/34 • Number of events 4 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
15.0%
6/40 • Number of events 6 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
10.3%
3/29 • Number of events 3 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
11.8%
4/34 • Number of events 4 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
|
Gastrointestinal disorders
bloating
|
8.8%
3/34 • Number of events 3 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
7.5%
3/40 • Number of events 3 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
6.9%
2/29 • Number of events 2 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
8.8%
3/34 • Number of events 3 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
|
Gastrointestinal disorders
heartburn
|
5.9%
2/34 • Number of events 2 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
5.0%
2/40 • Number of events 2 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
10.3%
3/29 • Number of events 3 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
5.9%
2/34 • Number of events 2 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
|
Nervous system disorders
headache
|
2.9%
1/34 • Number of events 1 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
7.5%
3/40 • Number of events 3 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
6.9%
2/29 • Number of events 2 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
2.9%
1/34 • Number of events 1 • We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
|
Additional Information
Dr. Alayne Markland, PI of this clinical trial
Birmingham VA Medical Center
Phone: 205-933-8101
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place