NCT01398163

Brief Summary

The purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on the brain activity within specific neural circuits regulating the subjective experience of emotional valence and digestive well-being.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
Last Updated

November 25, 2016

Status Verified

November 1, 2016

Enrollment Period

1.2 years

First QC Date

July 19, 2011

Last Update Submit

November 23, 2016

Conditions

Healthy Adult Women

Keywords

probioticsdigestive well-beingfMRIbrain-gut axis

Study Arms (3)

1 = Tested product

EXPERIMENTAL
Other: 1-Fermented Dairy Product (test)

2 = Control product

ACTIVE COMPARATOR
Other: 2-Milk-based non-fermented dairy product(control)

3 = No product

NO INTERVENTION

Interventions

1-Fermented Dairy Product (test)OTHER

Arm 1 - Intervention 1 (probiotics)

1 = Tested product
2-Milk-based non-fermented dairy product(control)OTHER

Arm 2 - Intervention 2 (control)

2 = Control product

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy women, right-handed, aged from 18 to 60 years
  • Subject of normal body weight or with overweight i.e. not obese (body mass index between 18 and 30 kg/m2).
  • For fertile women, complying with one of the other medically approved methods of contraception

You may not qualify if:

  • Subject with any current psychiatric or eating or suicidal attempt disorder, or history of such disorder.
  • Subject with any history of chronic GI disorder or disease.
  • Subject with any significant active or prior metabolic disorder or disease.
  • Subject with any use of probiotic supplements or antibiotics in the previous month.
  • Subject with current use of any medications with potential central nervous system effects (antidepressants, anxiolytics, opiate pain medications...).
  • Subject with allergy or hypersensitivity to milk proteins or lactose intolerance or immunodeficiency
  • Subjects with claustrophobia or other condition (such as metallic implants) that would preclude MRI scanning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA - University

Los Angeles, California, 90095-7170, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 20, 2011

Study Start

April 1, 2009

Primary Completion

June 1, 2010

Study Completion

December 1, 2010

Last Updated

November 25, 2016

Record last verified: 2016-11

Locations

US(1)