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Trial record 2 of 5 for:    fermented foods mood

Fermented Milk Product With Probiotic and Its Impact on Mood of Patients With Treatment Resistant Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03317678
Recruitment Status : Suspended (Uncertainty about funding)
First Posted : October 23, 2017
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center

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 Depressive Disorder (MDD) refractory to standard antidepressant therapy, and its association with changes in intestinal microbiota and markers of inflammation.

Condition or disease Intervention/treatment Phase
Depression Dietary Supplement: BioKefir Dietary Supplement: Non-fermented milk Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. 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.
  2. 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.
  3. Patients with Body Mass Indexes between 18 and 40.
  4. No planned antibiotic treatment during study to avoid antibiotic treatments for the duration of the study.

Exclusion Criteria

  1. 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.
  2. Lactose intolerant patients will not be able to participate due to the high likelihood of being unable to tolerate the specific intervention being implemented.
  3. Patients who have used BKP or Yogurt without probiotics daily for 12 weeks preceding study entry and unwilling to stop.
  4. 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.
  5. Patients with Substance Use Disorder. Within the past 12 months.
  6. 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).
  7. Patients with other significant clinical illnesses such as, but not limited to, Congestive Heart Failure, Diabetes Mellitus, Chronic Obstructive Pulmonary Disease.
  8. Patients who are currently using corticosteroid medications, or who have a history of multiple treatment courses with these medications.
  9. Patients on antibiotic treatment at the time of study entry or who have received such treatment during the 30 days prior to study entry.
  10. Patients using anti-inflammatory medications.
  11. Patients who are actively suicidal.

Information from the National Library of Medicine

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


Locations
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United States, Illinois
RushUMC
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03317678    
Other Study ID Numbers: 16060902
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders