Fermented Milk Product With Probiotic and Its Impact on Mood of Patients With Treatment Resistant Depression
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|ClinicalTrials.gov Identifier: NCT03317678|
Recruitment Status : Suspended (Uncertainty about funding)
First Posted : October 23, 2017
Last Update Posted : July 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Depression||Dietary Supplement: BioKefir Dietary Supplement: Non-fermented milk||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Fermented Milk Product With Probiotic and Its Impact on Mood of Patients With Treatment Resistant Depression|
|Actual Study Start Date :||February 10, 2017|
|Estimated Primary Completion Date :||February 10, 2020|
|Estimated Study Completion Date :||March 10, 2020|
Experimental: BioKefir (BKP)
BioKefir™ (Lifeway Foods) is a lactose-free fermented milk drink containing 12 different species of bacteria within the lactobacillus, bifidobacterium, and streptococcus generas totaling approximately 20 CFU per 3.5 ounce serving. The product also contains 2 g of fiber, including pectin and inulin. These fibers, especially inulin, are prebiotics that may function along with the probiotic species to support gastrointestinal health. The product is available commercially. Participants will be asked to consume 3.5 ounces twice daily, preferably at morning and nighttime. The probiotic will be provided in individual 3.5 ounce unlabeled containers. These quantities will be started on the first day of the intervention phase of the study (day 0, visit 0) and remain unchanged until the end of the intervention phase on day 56 (visit +4). Administration will be discontinued then.
Dietary Supplement: BioKefir
BKP BioKefir (Lifeway Foods) is a lactose-free fermented milk product containing 12 different bacteria provided in a drink.
Placebo Comparator: Non-fermented Milk (NFM)
The NFM is dairy-based product ultra-filtered to remove lactose. In addition to being matched to lactose, the NFM contains similar energy, fat, and protein content as the probiotic. Participants will be asked to consume 3.5 ounces twice daily, preferably at morning and nighttime. The NFM control will be provided in 11.5 ounce unlabeled containers. These quantities will be started on the first day of the intervention phase of the study (day 0, visit 0) and remain unchanged until the end of the intervention phase on day 56 (visit +4). Administration will be discontinued then.
Dietary Supplement: Non-fermented milk
A non-fermented milk drink.
- Changes in total score on the Montgomery-Åsberg Depression Rating [ Time Frame: Baseline assessments and every 2 weeks over 91 days ]The primary outcome measure will be change in the Montgomery-Åsberg Depression Rating Scale (MADRS). The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery & Åsberg, 1979).
- Changes in Clinical Global Impression-Severity Scale (CGI) [ Time Frame: Baseline assessments and every 2 weeks over 91 days ]Change in the Clinical Global Impression-Severity Scale (CGI) from baseline to weekly assessments. The CGI is a 7 point scale that measures symptom illness and global improvement or changes in severity
- Change in total score on the Computerized Adaptive Testing for Depression (CAT-D) [ Time Frame: Baseline assessments and every 2 weeks over 91 days ]CAT-D is a multidimensional item response questionnaire that selects a small-targeted set of items for each individual from a much larger bank of test items. CAT yields scores ranging from 0 to 100 and these will be used to assess changes in participants' mood from baseline and weekly assessments.
- Analysis of Intestinal Microbiota pre and post intervention [ Time Frame: Baseline and after 56 days of intervention. ]A quantitative analysis of the fecal microbiome will be conducted
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317678
|United States, Illinois|
|Chicago, Illinois, United States, 60612|