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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
5
2 billion CFU per capsule; One pill daily for 60 days
1 pill daily for 60 days
Ganeden BC30 (2 billion CFU per capsule), One capsule daily for 30 days Sugar Pill (placebo), One capsule daily for 30 days
Burlington Medical Associates
Burlington, Massachusetts, United States
Charles River Medical Associates
Westborough, Massachusetts, United States
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.
Time frame: Administered at each of 8 study visits (every 10 days), Endpoint is Final Visit
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Administered at each of 8 visits (every 10 days), Endpoint is Final Visit
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