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Probiotics for Bipolar Disorder
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have used illegal drugs by injecting them into your veins.You have been diagnosed with a significant learning disability or intellectual disability.I have HIV or another condition that weakens my immune system.I have had weight loss surgery in the past.I can understand and sign the consent form.Your liver enzymes (AST and ALT) are more than three times the normal limit.I can attend all required follow-up visits.I am experiencing mania due to medication or substance use.I have been diagnosed with bipolar I or schizoaffective disorder, bipolar type.I was hospitalized for mania symptoms within the last 3 weeks.You have been diagnosed with a moderate or severe alcohol or drug problem in the past 3 months, or have recently tested positive for drugs.Your body has unusual levels of minerals like sodium, potassium, or calcium in your blood.I have not had major surgery in the past year.I have been diagnosed with celiac disease and follow a gluten-free diet.I have a condition affecting my brain function, but not acute Hepatitis-C.
- Group 1: Placebo
- Group 2: Probiotic-Probio-Tec BG-VCap-6.5
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are we still enrolling people for this research project?
"Yes, this trial is still looking for patients. The listing on clinicaltrials.gov shows that the study was first posted on September 6th, 2018 and updated as recently as October 27th, 2020."
Has Probio-Tec BG-VCap-6.5 undergone FDA scrutiny?
"Probio-Tec BG-VCap-6.5's safety is based on data from Phase 2 trials, so it received a score of 2."
How many people are receiving treatment as part of this clinical trial?
"That is correct. Based on the information found on clinicaltrials.gov, this trial is still looking for 66 patients at 1 location. The posting date was September 6th, 2018 and the most recent update was October 27th, 2020."
Could older patients be at a disadvantage in this type of trial?
"The age range that is able to participate in this clinical trial spans from 18 years old to 65 years old."
If I wanted to participate in this research, would I be able to?
"Sought for this study are 66 individuals aged 18 to 65 that suffer from manic disorder. They must also be able to written informed consent, currently admitted or have been hospitalized in the past 3 weeks due to mania symptoms, have a primary Axis I DSM-5 diagnosis of bipolar I (single manic episode, most recent episode mixed) OR schizoaffective disorder - bipolar type (manic or mixed state), be proficient in English, and available for follow up visits."
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