NCT03284905

Brief Summary

Efficacy of probiotics on acute stress

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

September 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

October 2, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2018

Completed
Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

September 13, 2017

Last Update Submit

March 19, 2019

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

  • Reduction of the cortisol level during acute stress

    2.5 hours

Study Arms (2)

Probiotics

ACTIVE COMPARATOR
Dietary Supplement: Probiotic supplement

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo supplement

Interventions

Probiotic supplementDIETARY_SUPPLEMENT

Capsule containing freeze dried probiotic bacteria together with maize starch

Probiotics
Placebo supplementDIETARY_SUPPLEMENT

Capsule containing maize starch

Placebo

Eligibility Criteria

Age19 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • SMBQ-score ≥3.75
  • Understand Swedish in spoken and written terms
  • Willing and able to give written informed consent for participating in the study
  • Intake of probiotics within two weeks prior to the start of the study

You may not qualify if:

  • BMI\> 30
  • Pregnant
  • Antibiotic treatment in the last three months
  • Known disease (diabetes, pulmonary or cardiovascular disease, celiac disease, thyroid problems, gastrointestinal disease) or mental illness
  • Use of psychotropic drugs, beta blockers, asthma or rheumatoid arthritis drugs, steroid drugs or local steroid treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Food Technology, Engineering and Nutrition, Lund University

Lund, 223 00, Sweden

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2017

First Posted

September 15, 2017

Study Start

October 2, 2017

Primary Completion

April 4, 2018

Study Completion

April 4, 2018

Last Updated

March 20, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)