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

NCT03317678 | Completed

• 1 other identifier: 16060902
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Changes in total score on the Montgomery-Åsberg Depression Rating

  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).

  Baseline assessments and every 2 weeks over 91 days

Secondary Outcomes (3)

• Changes in Clinical Global Impression-Severity Scale (CGI)

  Baseline assessments and every 2 weeks over 91 days

• Change in total score on the Computerized Adaptive Testing for Depression (CAT-D)

  Baseline assessments and every 2 weeks over 91 days

• Analysis of Intestinal Microbiota pre and post intervention

  Baseline and after 56 days of intervention.

Study Arms (2)

BioKefir (BKP)

EXPERIMENTAL

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

Non-fermented Milk (NFM)

PLACEBO COMPARATOR

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

Interventions

BioKefir DIETARY_SUPPLEMENT

BKP BioKefir (Lifeway Foods) is a lactose-free fermented milk product containing 12 different bacteria provided in a drink.

BioKefir (BKP)

Non-fermented milk DIETARY_SUPPLEMENT

A non-fermented milk drink.

Non-fermented Milk (NFM)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

RushUMC

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: October 23, 2017
• Study Start: February 10, 2017
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)