Probio-Tec BG-VCap-6.5 for Bipolar Disorder

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Bipolar DisorderProbio-Tec BG-VCap-6.5 - CombinationProduct
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study whether probiotics are effective in treating people with mania or mixed episodes. 66 people will be hospitalized and given either probiotics or a placebo. The study will last 24 weeks and the primary outcome will be relapse, defined as re-hospitalization for psychiatric symptoms.

Eligible Conditions
  • Bipolar Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 24 weeks

24 weeks
Relapse rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Probiotic-Probio-Tec BG-VCap-6.5
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

66 Total Participants · 2 Treatment Groups

Primary Treatment: Probio-Tec BG-VCap-6.5 · Has Placebo Group · Phase 2

Probiotic-Probio-Tec BG-VCap-6.5
CombinationProduct
Experimental Group · 1 Intervention: Probio-Tec BG-VCap-6.5 · Intervention Types: CombinationProduct
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
953 Previous Clinical Trials
608,680 Total Patients Enrolled
20 Trials studying Bipolar Disorder
4,434 Patients Enrolled for Bipolar Disorder
Sherwood Brown, MD, PhDPrincipal Investigator - UT Southwestern Medical Center
University of Texas Southwestern Medical Center
6 Previous Clinical Trials
730 Total Patients Enrolled
2 Trials studying Bipolar Disorder
230 Patients Enrolled for Bipolar Disorder

Eligibility Criteria

Age 18 - 65 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are currently admitted to inpatient hospital for symptoms of mania.
You have a native or fluent English language.