Study of Probiotic GanedenBC30 for Irritable Bowel Syndrome and Major Depressive Disorder

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and effectiveness of a nutritional supplement, the probiotic bacteria GanedenBC30. Probiotics are live microorganisms which when taken in large enough amounts are supposed to provide a health benefit. The investigators would like to see whether this supplement can be used as a treatment for Irritable Bowel Syndrome (IBS) and Major Depressive Disorder (MDD). Participants in the study will have both IBS and MDD. In order to find out if GanedenBC30 is effective in treating IBS and MDD, the investigators will compare it to a placebo. About 32 people will take part in this research study. About half of these 32 people will take part at Charles River Medical Associates and half will take part at Burlington Medical Associates. Participants will be recruited from among patients already being seen at Charles River Medical Associates or Burlington Medical Associates for their primary care. The study will last for two months, during which time participants will make eight study visits and will take either Ganeden BC30 or placebo. The investigators hypothesize that subjects treated with the probiotic will have significantly better outcomes with regard to depression and IBS symptoms compared to those who receive placebo.

Official Title
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A Double-Blind, Placebo-Controlled Study of the Probiotic Ganeden BC30 (Bacillus Coagulans GBI-30, 6068) in Irritable Bowel Syndrome Comorbid With Major Depressive Disorder (MDD)

Conditions
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Major Depressive Disorder, Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: Ganeden BC30
* Other: Placebo (sugar pill)
* Other: Ganeden BC30, Placebo (sugar pill)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to give Informed Consent Meet criteria for Irritable Bowel Syndrome Meet criteria for Major Depressive Disorder Men and women ages 18 to 65 Women of childbearing potential must be using an adequate methods of contraception Can be on an antidepressant medications, but must have been on the medication for at least 8 weeks and at a stable dose for 4 weeks Can be on medications for IBS, but must have been on medications for at least 8 weeks and at a stable dose for 4 weeks Exclusion Criteria: Patients who have failed one or more trials of probiotics for IBS Patients who report an inadequate response to less than two or more than four adequate trails of antidepressant treatments during the current depressive episode at a therapeutic dose for an adequate duration Women who are pregnant or breastfeeding Patients with alarm signs or red flags as defined by American Gastroenterological Association (AGA) are excluded [6], unless they have been fully evaluated to rule out other significant diseases. Patients with known diagnoses of digestive organic disease, celiac disease and lactose intolerance prior to the screening. Patients who report an inadequate response (less than 50% decrease in depressive symptom severity) to less than two or more than four prior adequate trials of antidepressant treatments during the current depressive episode (including monotherapy treatment and distinct combination regimens) at a therapeutic dose (as defined by the MGH-ATRQ) and for an adequate duration (minimum six weeks for any monotherapy). Patients who report treatment with adjunctive medications to their antidepressant for a minimum of four weeks during the current depressive episode. Patients with a current need for involuntary commitment or who have been hospitalized within four weeks of the Screening Visit for the current major depressive episode. Patients who have received ECT during the current episode. Patients who have a current Axis I diagnosis of: Delirium, dementia, amnestic, or other cognitive disorder; Schizophrenia or other psychotic disorder, based on the PDSQ; Bipolar I or II disorder, based on the PDSQ; Patients with a clinically significant Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder. Patients experiencing hallucinations, delusions, or any psychotic symptomatology in the current depressive episode. Patients who have met DSM-IV-TR criteria for any significant substance use disorder within the past six months, based on the PDSQ. Patients receiving new onset depression-focused psychotherapy within 6 weeks of screening, or at any time during participation in the trial. Patients who have been previously randomized in a probiotics clinical trial (lifetime). Patients who have participated in any clinical trial with an investigational drug or device within the past month. Patients who, in the opinion of the investigator, are actively suicidal or homicidal and at significant risk for suicide or homicide.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GanedenBC30<br>Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days. | Drug: Ganeden BC30<br>* 2 billion CFU per capsule; One pill daily for 60 days<br>|
| Placebo Comparator: Sugar pill<br>Arm 2 will take placebo (sugar pill) for 60 days. | Other: Placebo (sugar pill)<br>* 1 pill daily for 60 days<br>|
| Other: Ganeden BC30, Sugar pill<br>Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days. | Other: Ganeden BC30, Placebo (sugar pill)<br>* Ganeden BC30 (2 billion CFU per capsule), One capsule daily for 30 days Sugar Pill (placebo), One capsule daily for 30 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) | 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. | Administered at each of 8 study visits (every 10 days), Endpoint is Final Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBS Severity Scoring System (IBS-SSS) | 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. | Adminsitered at each of 8 study visits (every 10 days), Endpoint is Final Visit | 
| Visual Analog Scale (VAS) | 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. | Administered at each of 8 study visits (every 10 days), Endpoint is Final Visit | 
| Adequate Relief of IBS Pain (AR-IBS) | The AR-IBS is a self-administered measure of the adequacy of the relief of IBS pain. | Adminstered at each of 8 visits (every 10 days), Endpoint is Final Visit | 
| Patient Global Impression of Change (PGI-C) - IBS Symptoms | 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. | Administered at each of 8 visits (every 10 days), Endpoint is Final Visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Irritable Bowel Syndrome, Probiotic, Bacillus Coagulans