Trial Outcomes & Findings for Double-Blind Trial of a Probiotic Supplement to Reduce the Symptoms of Schizophrenia (NCT NCT01242371)
NCT ID: NCT01242371
Last Updated: 2019-02-05
Results Overview
The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale.
COMPLETED
NA
65 participants
14 weeks (week 0 to week 14)
2019-02-05
Participant Flow
We enrolled n=65 participants drawn from rehabilitation and treatment programs in Central Maryland. Dates of recruitment 11/2010-01/2012.
We used a 2 week placebo run in for all participants prior to randomization. This placebo run in was followed by the 14 week double-blind treatment phase.
Participant milestones
| Measure |
Probiotic Supplement
Probiotic supplement 1 tablet by mouth daily for 14 weeks
|
Identical-appearing Placebo
Identical appearing placebo 1 tablet by mouth daily for 14 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
32
|
|
Overall Study
COMPLETED
|
31
|
27
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Probiotic Supplement
Probiotic supplement 1 tablet by mouth daily for 14 weeks
|
Identical-appearing Placebo
Identical appearing placebo 1 tablet by mouth daily for 14 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Protocol Violation
|
0
|
3
|
Baseline Characteristics
Double-Blind Trial of a Probiotic Supplement to Reduce the Symptoms of Schizophrenia
Baseline characteristics by cohort
| Measure |
Probiotic Supplement
n=33 Participants
Probiotic supplement 1 tablet by mouth daily for 14 weeks
|
Identical-appearing Placebo
n=32 Participants
Identical appearing placebo 1 tablet by mouth daily for 14 weeks
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
44.4 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
48.1 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
46.2 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
32 participants
n=7 Participants
|
65 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 weeks (week 0 to week 14)Population: Week 0 data is based on the number of participants in the probiotic supplement group (n=33) and the placebo group (n=32) who began the treatment phase. Week 14 data is based on the number of participants in the probiotics supplement group (n=31) and the placebo group (n=27) who completed the treatment phase.
The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale.
Outcome measures
| Measure |
Probiotic Supplement
n=33 Participants
Probiotic supplement 1 tablet by mouth daily for 14 weeks
|
Identical-appearing Placebo
n=32 Participants
Identical appearing placebo 1 tablet by mouth daily for 14 weeks
|
|---|---|---|
|
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase (Week 0 to Week 14)
Wk 0 (Begin Treatment) PANSS Total Score, n=33,32
|
67.55 units on a scale
Standard Deviation 11.64
|
69.56 units on a scale
Standard Deviation 11.73
|
|
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase (Week 0 to Week 14)
Wk 14 (End Treatment) PANSS Total Score, n=31,27
|
67.42 units on a scale
Standard Deviation 11.66
|
67.69 units on a scale
Standard Deviation 11.86
|
SECONDARY outcome
Timeframe: 14 weeks (weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 & 14)Self report rating of difficulty moving bowels on a 4 point scale from "no difficulty" to "severe difficulty"
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 16 weeks (baseline prior to placebo run in to week 14)Outcome measures
Outcome data not reported
Adverse Events
Probiotic Supplement
Identical-appearing Placebo
Serious adverse events
| Measure |
Probiotic Supplement
n=33 participants at risk
Probiotic supplement 1 tablet by mouth daily for 14 weeks
|
Identical-appearing Placebo
n=32 participants at risk
Identical appearing placebo 1 tablet by mouth daily for 14 weeks
|
|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
3.0%
1/33 • Number of events 1 • Adverse events were collected over a 16 week period, including the 2 week placebo run in and the 14 week double-blind treatment phase.
|
0.00%
0/32 • Adverse events were collected over a 16 week period, including the 2 week placebo run in and the 14 week double-blind treatment phase.
|
|
Psychiatric disorders
Schizophrenia exacerbation
|
6.1%
2/33 • Number of events 3 • Adverse events were collected over a 16 week period, including the 2 week placebo run in and the 14 week double-blind treatment phase.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected over a 16 week period, including the 2 week placebo run in and the 14 week double-blind treatment phase.
|
Other adverse events
| Measure |
Probiotic Supplement
n=33 participants at risk
Probiotic supplement 1 tablet by mouth daily for 14 weeks
|
Identical-appearing Placebo
n=32 participants at risk
Identical appearing placebo 1 tablet by mouth daily for 14 weeks
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatological condition
|
3.0%
1/33 • Number of events 1 • Adverse events were collected over a 16 week period, including the 2 week placebo run in and the 14 week double-blind treatment phase.
|
9.4%
3/32 • Number of events 6 • Adverse events were collected over a 16 week period, including the 2 week placebo run in and the 14 week double-blind treatment phase.
|
|
Gastrointestinal disorders
Diarrhea
|
27.3%
9/33 • Number of events 9 • Adverse events were collected over a 16 week period, including the 2 week placebo run in and the 14 week double-blind treatment phase.
|
18.8%
6/32 • Number of events 8 • Adverse events were collected over a 16 week period, including the 2 week placebo run in and the 14 week double-blind treatment phase.
|
|
Gastrointestinal disorders
Gastrointestonal symptoms (excluding diarrhea)
|
15.2%
5/33 • Number of events 5 • Adverse events were collected over a 16 week period, including the 2 week placebo run in and the 14 week double-blind treatment phase.
|
21.9%
7/32 • Number of events 9 • Adverse events were collected over a 16 week period, including the 2 week placebo run in and the 14 week double-blind treatment phase.
|
|
Renal and urinary disorders
Genitourinary condition
|
6.1%
2/33 • Number of events 2 • Adverse events were collected over a 16 week period, including the 2 week placebo run in and the 14 week double-blind treatment phase.
|
6.2%
2/32 • Number of events 3 • Adverse events were collected over a 16 week period, including the 2 week placebo run in and the 14 week double-blind treatment phase.
|
|
Nervous system disorders
Headache
|
6.1%
2/33 • Number of events 3 • Adverse events were collected over a 16 week period, including the 2 week placebo run in and the 14 week double-blind treatment phase.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected over a 16 week period, including the 2 week placebo run in and the 14 week double-blind treatment phase.
|
|
Musculoskeletal and connective tissue disorders
Musculoskelatol condition
|
6.1%
2/33 • Number of events 2 • Adverse events were collected over a 16 week period, including the 2 week placebo run in and the 14 week double-blind treatment phase.
|
6.2%
2/32 • Number of events 2 • Adverse events were collected over a 16 week period, including the 2 week placebo run in and the 14 week double-blind treatment phase.
|
|
Psychiatric disorders
Psychiatric condition
|
12.1%
4/33 • Number of events 4 • Adverse events were collected over a 16 week period, including the 2 week placebo run in and the 14 week double-blind treatment phase.
|
6.2%
2/32 • Number of events 2 • Adverse events were collected over a 16 week period, including the 2 week placebo run in and the 14 week double-blind treatment phase.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory illness
|
36.4%
12/33 • Number of events 14 • Adverse events were collected over a 16 week period, including the 2 week placebo run in and the 14 week double-blind treatment phase.
|
31.2%
10/32 • Number of events 10 • Adverse events were collected over a 16 week period, including the 2 week placebo run in and the 14 week double-blind treatment phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place