Status:
COMPLETED
Fermented Milk Product With Probiotic and Its Impact on Mood of Patients With Treatment Resistant Depression
Lead Sponsor:
Rush University Medical Center
Conditions:
Depression
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
This study aims to assess the impact of a chronic dietary intervention (8 weeks) with probiotics, specifically Fermented Milk Product with Probiotic (FMPP), on the mood of individuals with Major Depre...
Detailed Description
Theories about the association of imbalances in the gastro-intestinal (GI) microbiota and its impact on mood states have long existed in medicine. These theories were considered "dead" for most of the...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Men and women between 21 and 65 years of age meeting DSM-V criteria for Major Depressive Disorder and presenting a HAM-D score of 18 or higher.
- If patients are on antidepressants (ie. fluoxetine 20 mg/d or its equivalent) the dose needs to be stable for at least 6 weeks prior to screening.
- Patients with Body Mass Indexes between 18 and 40.
- No planned antibiotic treatment during study to avoid antibiotic treatments for the duration of the study.
- Exclusion Criteria
- Patients who are vegan or observe other specific dietary patterns that are not representative of the general population and may specifically impact their microbiomes will be excluded from the study.
- Lactose intolerant patients will not be able to participate due to the high likelihood of being unable to tolerate the specific intervention being implemented.
- Patients who have used BKP or Yogurt without probiotics daily for 12 weeks preceding study entry and unwilling to stop.
- Patients with a past history of Eating Disorders or Psychotic Disorders. Patients with Bipolar Disorder, past or current, who are currently taking a mood stabilizer.
- Patients with Substance Use Disorder. Within the past 12 months.
- Patients with a history of 3 or more failed trials of antidepressant medications of adequate dose or duration (i.e. fluoxetine 20 mg/d or its equivalent for 6 weeks or more).
- Patients with other significant clinical illnesses such as, but not limited to, Congestive Heart Failure, Diabetes Mellitus, Chronic Obstructive Pulmonary Disease.
- Patients who are currently using corticosteroid medications, or who have a history of multiple treatment courses with these medications.
- Patients on antibiotic treatment at the time of study entry or who have received such treatment during the 30 days prior to study entry.
- Patients using anti-inflammatory medications.
- Patients who are actively suicidal.
Exclusion
Key Trial Info
Start Date :
February 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03317678
Start Date
February 10 2017
End Date
December 7 2022
Last Update
December 9 2022
Active Locations (1)
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1
RushUMC
Chicago, Illinois, United States, 60612