Trial Outcomes & Findings for Study of Probiotic GanedenBC30 for Irritable Bowel Syndrome and Major Depressive Disorder (NCT NCT01337609)
NCT ID: NCT01337609
Last Updated: 2013-08-09
Results Overview
The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)is a self report measure that addresses depressive symptoms. MDD responders will be defined as those exhibiting a 50% decrease in the QIDS SR at study endpoint.
TERMINATED
PHASE4
5 participants
Administered at each of 8 study visits (every 10 days), Endpoint is Final Visit
2013-08-09
Participant Flow
Participant milestones
| Measure |
GanedenBC30
Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
|
Sugar Pill
Arm 2 will take placebo (sugar pill) for 60 days.
|
Ganeden BC30, Sugar Pill
Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
2
|
|
Overall Study
COMPLETED
|
0
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Probiotic GanedenBC30 for Irritable Bowel Syndrome and Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
GanedenBC30
n=1 Participants
Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
|
Sugar Pill
n=2 Participants
Arm 2 will take placebo (sugar pill) for 60 days.
|
Ganeden BC30, Sugar Pill
n=2 Participants
Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
|
Total
n=5 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Administered at each of 8 study visits (every 10 days), Endpoint is Final VisitPopulation: Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.
The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)is a self report measure that addresses depressive symptoms. MDD responders will be defined as those exhibiting a 50% decrease in the QIDS SR at study endpoint.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Adminsitered at each of 8 study visits (every 10 days), Endpoint is Final VisitPopulation: Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.
The IBS-SSS is a validated instrument used to assess common IBS symptoms over the past 10 days including abdominal pain, distention, bowel habit, and global function. The IBS-SSS will be used to assess the absolute change in specific IBS symptoms at endpoint, namely the bloating/distension score.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Administered at each of 8 study visits (every 10 days), Endpoint is Final VisitPopulation: Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.
The VAS is a self-administered measure of abdominal pain, discomfort, and bloating. The change in total score from baseline to study endpoint will be assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Adminstered at each of 8 visits (every 10 days), Endpoint is Final VisitPopulation: Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.
The AR-IBS is a self-administered measure of the adequacy of the relief of IBS pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Administered at each of 8 visits (every 10 days), Endpoint is Final VisitPopulation: Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.
The PGI-C is a self-administered measure of the degree of improvement in IBS symptoms compared to the first study visit. Degree of improvement in IBS symptoms from first to final visit will be assessed using this scale.
Outcome measures
Outcome data not reported
Adverse Events
Placebo for 60 Days
GanedenBC30 for 60 Days
Placebo for 30 Days, Followed by GanedenBC30 for 30 Days
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo for 60 Days
n=2 participants at risk
|
GanedenBC30 for 60 Days
n=1 participants at risk
|
Placebo for 30 Days, Followed by GanedenBC30 for 30 Days
n=2 participants at risk
|
|---|---|---|---|
|
Cardiac disorders
Cerebral infarct; residual leg weakness and face drooping
|
0.00%
0/2
|
100.0%
1/1 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Labial cyst, constipation, and tension headache
|
0.00%
0/2
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
|
Immune system disorders
Sore throat
|
0.00%
0/2
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
|
Infections and infestations
Sinus infection
|
0.00%
0/2
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Right flank pain
|
0.00%
0/2
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place