Trial Outcomes & Findings for A Probiotic Intervention to Prevent Relapse Following Hospitalization for Mania (NCT NCT03383874)
NCT ID: NCT03383874
Last Updated: 2025-12-19
Results Overview
'Relapse' is defined as re-hospitalization (e.g., admission to an inpatient unit) for psychiatric symptoms following a previous hospital discharge by at least 2 weeks. The rate of relapse was calculated by dividing the number of re-hospitalizations per group (i.e., Placebo, Probiotic) by the number of participants per group so the unit is re-hospitalizations/participant.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
67 participants
Primary outcome timeframe
24 weeks
Results posted on
2025-12-19
Participant Flow
Participant milestones
| Measure |
Placebo
Participants will receive capsules containing placebo for 24-weeks.
|
Probiotic-Probio-Tec BG-VCap-6.5
Participants will receive capsules containing approximately 10\^9 colony forming units of the probiotic organisms, Lactobacillus GG and Bifidobacteria lactis strain Bb12 for 24-weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
31
|
|
Overall Study
COMPLETED
|
20
|
25
|
|
Overall Study
NOT COMPLETED
|
16
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Probiotic Intervention to Prevent Relapse Following Hospitalization for Mania
Baseline characteristics by cohort
| Measure |
Placebo
n=36 Participants
Participants will receive capsules containing placebo for 24-weeks.
|
Probiotic-Probio-Tec BG-VCap-6.5
n=31 Participants
Participants will receive capsules containing approximately 10\^9 colony forming units of the probiotic organisms, Lactobacillus GG and Bifidobacteria lactis strain Bb12 for 24-weeks.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=8 Participants
|
30 Participants
n=6 Participants
|
65 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Age, Continuous
|
33.97 Years
STANDARD_DEVIATION 17.08 • n=8 Participants
|
32.29 Years
STANDARD_DEVIATION 10.18 • n=6 Participants
|
33.19 Years
STANDARD_DEVIATION 12.27 • n=6 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=8 Participants
|
18 Participants
n=6 Participants
|
35 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=8 Participants
|
13 Participants
n=6 Participants
|
32 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=8 Participants
|
12 Participants
n=6 Participants
|
20 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=8 Participants
|
17 Participants
n=6 Participants
|
42 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=8 Participants
|
5 Participants
n=6 Participants
|
19 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=8 Participants
|
26 Participants
n=6 Participants
|
48 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 24 weeks'Relapse' is defined as re-hospitalization (e.g., admission to an inpatient unit) for psychiatric symptoms following a previous hospital discharge by at least 2 weeks. The rate of relapse was calculated by dividing the number of re-hospitalizations per group (i.e., Placebo, Probiotic) by the number of participants per group so the unit is re-hospitalizations/participant.
Outcome measures
| Measure |
Placebo
n=36 Participants
Participants will receive capsules containing placebo for 24-weeks.
|
Probiotic-Probio-Tec BG-VCap-6.5
n=31 Participants
Participants will receive capsules containing approximately 10\^9 colony forming units of the probiotic organisms, Lactobacillus GG and Bifidobacteria lactis strain Bb12 for 24-weeks.
|
|---|---|---|
|
Rate of Relapse
|
.11 Proportion of Participants
|
.13 Proportion of Participants
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 20 other events
Deaths: 1 deaths
Probiotic-Probio-Tec BG-VCap-6.5
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=36 participants at risk
Participants will receive capsules containing placebo for 24-weeks.
|
Probiotic-Probio-Tec BG-VCap-6.5
n=31 participants at risk
Participants will receive capsules containing approximately 10\^9 colony forming units of the probiotic organisms, Lactobacillus GG and Bifidobacteria lactis strain Bb12 for 24-weeks.
|
|---|---|---|
|
Psychiatric disorders
Hospitalization due to Manic Symptoms
|
2.8%
1/36 • Number of events 2 • 24 weeks
|
3.2%
1/31 • Number of events 1 • 24 weeks
|
|
Surgical and medical procedures
Death due to Surgical Complication
|
2.8%
1/36 • Number of events 1 • 24 weeks
|
0.00%
0/31 • 24 weeks
|
|
Psychiatric disorders
Suicide Attempt
|
2.8%
1/36 • Number of events 1 • 24 weeks
|
0.00%
0/31 • 24 weeks
|
Other adverse events
| Measure |
Placebo
n=36 participants at risk
Participants will receive capsules containing placebo for 24-weeks.
|
Probiotic-Probio-Tec BG-VCap-6.5
n=31 participants at risk
Participants will receive capsules containing approximately 10\^9 colony forming units of the probiotic organisms, Lactobacillus GG and Bifidobacteria lactis strain Bb12 for 24-weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Bloating
|
13.9%
5/36 • Number of events 5 • 24 weeks
|
3.2%
1/31 • Number of events 1 • 24 weeks
|
|
Infections and infestations
Common Cold
|
8.3%
3/36 • Number of events 3 • 24 weeks
|
6.5%
2/31 • Number of events 2 • 24 weeks
|
|
Gastrointestinal disorders
Constipation
|
5.6%
2/36 • Number of events 2 • 24 weeks
|
3.2%
1/31 • Number of events 2 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
27.8%
10/36 • Number of events 14 • 24 weeks
|
22.6%
7/31 • Number of events 7 • 24 weeks
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
3/36 • Number of events 4 • 24 weeks
|
3.2%
1/31 • Number of events 1 • 24 weeks
|
|
Gastrointestinal disorders
Stomach Discomfort
|
5.6%
2/36 • Number of events 3 • 24 weeks
|
6.5%
2/31 • Number of events 2 • 24 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/36 • 24 weeks
|
6.5%
2/31 • Number of events 2 • 24 weeks
|
|
Gastrointestinal disorders
Increased Appetite
|
2.8%
1/36 • Number of events 1 • 24 weeks
|
9.7%
3/31 • Number of events 3 • 24 weeks
|
|
Gastrointestinal disorders
Increased Frequency of Bowel Movements
|
0.00%
0/36 • 24 weeks
|
9.7%
3/31 • Number of events 5 • 24 weeks
|
|
Gastrointestinal disorders
Indigestion
|
0.00%
0/36 • 24 weeks
|
6.5%
2/31 • Number of events 2 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
2.8%
1/36 • Number of events 1 • 24 weeks
|
9.7%
3/31 • Number of events 3 • 24 weeks
|
|
Metabolism and nutrition disorders
Weight Gain
|
0.00%
0/36 • 24 weeks
|
9.7%
3/31 • Number of events 3 • 24 weeks
|
Additional Information
Dr. E. Sherwood Brown
University of Texas Southwestern Medical Center
Phone: 214-645-6950
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place