Trial Outcomes & Findings for Probiotics to Prevent Relapse After Hospitalization for Mania (NCT NCT01731171)

NCT ID: NCT01731171

Last Updated: 2019-01-07

Results Overview

The primary outcome was the time to first psychiatric inpatient rehospitalization.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 66 participants
• Primary outcome timeframe: Weeks 0 - 24 of study participation
• Results posted on: 2019-01-07

Participant Flow

Participant milestones

Measure	Probiotic Supplement The probiotic supplement compound will consist of capsules containing approximately 10\^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks. Probiotic Supplement: Probiotic Supplement 1 tablet by mouth daily	Inert Compound The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks. Inert Compound: Probiotic identical placebo 1 tablet by mouth daily
Overall Study STARTED	33	33
Overall Study COMPLETED	26	26
Overall Study NOT COMPLETED	7	7

Reasons for withdrawal

Measure	Probiotic Supplement The probiotic supplement compound will consist of capsules containing approximately 10\^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks. Probiotic Supplement: Probiotic Supplement 1 tablet by mouth daily	Inert Compound The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks. Inert Compound: Probiotic identical placebo 1 tablet by mouth daily
Overall Study Withdrawal by Subject	4	1
Overall Study Lost to Follow-up	3	2
Overall Study Moved out of Area	0	2
Overall Study Terminated for Lack of Adherence	0	1
Overall Study Terminated for Safety Reasons	0	1

Baseline Characteristics

Probiotics to Prevent Relapse After Hospitalization for Mania

Baseline characteristics by cohort

Measure	Probiotic Supplement n=33 Participants The probiotic supplement compound will consist of capsules containing approximately 10\^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks. Probiotic Supplement: Probiotic Supplement 1 tablet by mouth daily	Inert Compound n=33 Participants The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks. Inert Compound: Probiotic identical placebo 1 tablet by mouth daily	Total n=66 Participants Total of all reporting groups
Age, Continuous	37.9 years STANDARD_DEVIATION 11.7 • n=5 Participants	33.3 years STANDARD_DEVIATION 13.3 • n=7 Participants	35.58 years STANDARD_DEVIATION 12.66 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	18 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	15 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized Race · Caucasian	29 Participants n=5 Participants	21 Participants n=7 Participants	50 Participants n=5 Participants
Race/Ethnicity, Customized Race · African American	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	33 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: Weeks 0 - 24 of study participation

The primary outcome was the time to first psychiatric inpatient rehospitalization.

Outcome measures

Measure	Probiotic Supplement n=33 Participants The probiotic supplement compound will consist of capsules containing approximately 10\^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks. Probiotic Supplement: Probiotic Supplement 1 tablet by mouth daily	Inert Compound n=33 Participants The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks. Inert Compound: Probiotic identical placebo 1 tablet by mouth daily
Time to First Rehospitalization	168 Days to first readmission Interval 134.0 to 169.0	139 Days to first readmission Interval 32.0 to 168.0

SECONDARY outcome

Timeframe: Weeks 0 - 24 of study participation

This is a count of the participants who had at least one rehospitalization during the study period.

Outcome measures

Measure	Probiotic Supplement n=33 Participants The probiotic supplement compound will consist of capsules containing approximately 10\^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks. Probiotic Supplement: Probiotic Supplement 1 tablet by mouth daily	Inert Compound n=33 Participants The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks. Inert Compound: Probiotic identical placebo 1 tablet by mouth daily
Number of Participants Rehospitalized	8 Participants	17 Participants

SECONDARY outcome

Timeframe: Weeks 0 - 24 of study participation

This is a count of the number of rehospitalizations in each group during the study period.

Outcome measures

Measure	Probiotic Supplement n=33 Participants The probiotic supplement compound will consist of capsules containing approximately 10\^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks. Probiotic Supplement: Probiotic Supplement 1 tablet by mouth daily	Inert Compound n=33 Participants The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks. Inert Compound: Probiotic identical placebo 1 tablet by mouth daily
Total Number of Rehospitalizations	8 rehospitalizations	24 rehospitalizations

SECONDARY outcome

Timeframe: Weeks 0 - 24 of study participation

This is the mean number of days rehospitalized for participants in each group during the study period.

Outcome measures

Measure	Probiotic Supplement n=33 Participants The probiotic supplement compound will consist of capsules containing approximately 10\^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks. Probiotic Supplement: Probiotic Supplement 1 tablet by mouth daily	Inert Compound n=33 Participants The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks. Inert Compound: Probiotic identical placebo 1 tablet by mouth daily
Mean Days Rehospitalized	2.8 Days Standard Deviation 6.3	8.3 Days Standard Deviation 12.4

Adverse Events

Probiotic Supplement

Serious events: 8 serious events

Other events: 31 other events

Deaths: 0 deaths

Inert Compound

Serious events: 17 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Measure	Probiotic Supplement n=33 participants at risk The probiotic supplement compound will consist of capsules containing approximately 10\^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks. Probiotic Supplement: Probiotic Supplement 1 tablet by mouth daily	Inert Compound n=33 participants at risk The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks. Inert Compound: Probiotic identical placebo 1 tablet by mouth daily
Psychiatric disorders Psychiatric rehospitalization	24.2% 8/33 • Number of events 8 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.	51.5% 17/33 • Number of events 24 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.
Metabolism and nutrition disorders Hospitalization after a fall	3.0% 1/33 • Number of events 1 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.	0.00% 0/33 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.

Other adverse events

Measure	Probiotic Supplement n=33 participants at risk The probiotic supplement compound will consist of capsules containing approximately 10\^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks. Probiotic Supplement: Probiotic Supplement 1 tablet by mouth daily	Inert Compound n=33 participants at risk The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks. Inert Compound: Probiotic identical placebo 1 tablet by mouth daily
Gastrointestinal disorders Gastrointestinal Illness/Condition	81.8% 27/33 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.	75.8% 25/33 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.
Cardiac disorders Cardiovascular Illness/Condition	6.1% 2/33 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.	12.1% 4/33 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.
Renal and urinary disorders Genitourinary Illness/Conition	6.1% 2/33 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.	18.2% 6/33 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.
Endocrine disorders Metabolic and/or Endocrine Illness/Condition	9.1% 3/33 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.	0.00% 0/33 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.
Musculoskeletal and connective tissue disorders Musculoskeletal Illness/Condition	33.3% 11/33 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.	18.2% 6/33 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.
Nervous system disorders Neurological or Sensory Illness/Condition	18.2% 6/33 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.	30.3% 10/33 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.
Respiratory, thoracic and mediastinal disorders Respiratory Illness/Condition	51.5% 17/33 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.	45.5% 15/33 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.
Infections and infestations Infections	6.1% 2/33 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.	6.1% 2/33 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.
General disorders Dental Illness/Condition	6.1% 2/33 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.	9.1% 3/33 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.
Skin and subcutaneous tissue disorders Dermatological Illness/Condition	6.1% 2/33 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.	3.0% 1/33 • Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial. The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.

Additional Information

Dr. Faith Dickerson

Sheppard Pratt Health System

Phone: 410-938-4359

Email: fdickerson@sheppardpratt.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place