NCT03801655

Brief Summary

Probiotics are live bacteria which have been suggested to have beneficial effects not only on gut function but also on psychological and cognitive functioning. This study will investigate how a specific probiotic influences emotional and cognitive processing in participants with low mood.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

August 15, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2020

Completed
Last Updated

January 11, 2019

Status Verified

December 1, 2018

Enrollment Period

2 years

First QC Date

December 4, 2018

Last Update Submit

January 10, 2019

Conditions

MoodCognitive Change

Outcome Measures

Primary Outcomes (6)

  • Facial Expression Recognition Task

    2 hours

  • Emotional Categorization Task

    2 hours

  • Emotional Recall Task

    2 hours

  • Emotional Recognition Memory Task

    2 hours

  • Attentional Dot-Probe

    2 hours

  • Reward Learning Task

    2 hours

Secondary Outcomes (5)

  • Priming Task

    2 hours

  • Objective sleep

    2 weeks

  • Biological measures: cortisol

    4 weeks

  • Biological measures: immune markers

    4 weeks

  • Auditory Verbal Learning Task

    2 hours

Study Arms (2)

Bio-Kult

EXPERIMENTAL

4 capsules/day

Dietary Supplement: Bio-Kult

Placebo

PLACEBO COMPARATOR

4 capsules/day

Other: Placebo

Interventions

Bio-KultDIETARY_SUPPLEMENT

4 capsules/day

Bio-Kult
PlaceboOTHER

4 capsules/day

Also known as: Cellulose and vegetable capsules
Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants are willing and able to give informed consent for participation in the study.
  • Male or female, aged between 18 and 55 years.
  • Body mass index (BMI) within the range of 18.5 - 30 kg/m2.
  • Sufficiently fluent in English to understand the tasks and instructions.
  • Score between 5 and 19 on the Patient Health Questionnaire (PHQ-9).
  • Participants not judged to be at risk of suicide or self-harm (as measured using the SCID) and/or in need of immediate treatment to the discretion of the Investigators.

You may not qualify if:

  • Current history of Axis I psychiatric disorder except for depression or anxiety;
  • Current intake (or intention to take) any medication that may affect the outcomes, including medications affecting brain processing, sedation, and motility (examples include antidepressants, anxiolytics, among others);
  • Current psychological therapy;
  • Major medical disorders (including diseases affecting the human gastrointestinal tract);
  • Intake of any other food supplements which, in the opinion of the Investigators, may affect the results;
  • Any significant change in diet which, to the discretion of the Investigators, may affect the results;
  • Recent participation in another research trial which, to the discretion of the Investigators, may affect the results (for example, using the same / a similar battery of cognitive / emotional tasks in the last 3 months);
  • Dyslexia (given the nature of the computer tasks);
  • Any other significant finding arising during the screening/selection process which, in the opinion of the Investigators, may influence the participant's ability to take part in the study or the study results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Warneford Hospital

Oxford, Oxfordshire, OX3 7JX, United Kingdom

RECRUITING

MeSH Terms

Interventions

CelluloseVegetables

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Phil Burnet, PhD

    University of Oxford

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rita Baiao, PhD

CONTACT

01865613128rita.baiao@psych.ox.ac.uk

Study Design

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

Study Record Dates

First Submitted

December 4, 2018

First Posted

January 11, 2019

Study Start

August 15, 2018

Primary Completion

August 15, 2020

Study Completion

August 15, 2020

Last Updated

January 11, 2019

Record last verified: 2018-12

Locations

GB(1)