Probiotic Intervention for Acute Stress

NCT ID: NCT03284905

Last Updated: 2019-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-02

Study Completion Date

2018-04-04

Brief Summary

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Efficacy of probiotics on acute stress

Detailed Description

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Conditions

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Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotics

Group Type ACTIVE_COMPARATOR

Probiotic supplement

Intervention Type DIETARY_SUPPLEMENT

Capsule containing freeze dried probiotic bacteria together with maize starch

Placebo

Group Type PLACEBO_COMPARATOR

Placebo supplement

Intervention Type DIETARY_SUPPLEMENT

Capsule containing maize starch

Interventions

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Probiotic supplement

Capsule containing freeze dried probiotic bacteria together with maize starch

Intervention Type DIETARY_SUPPLEMENT

Placebo supplement

Capsule containing maize starch

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 19-35 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

Exclusion Criteria

* 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Probi AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Food Technology, Engineering and Nutrition, Lund University

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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SP17

Identifier Type: -

Identifier Source: org_study_id

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