Probiotic Intervention for Acute Stress

Stress Clinical Trial

Official title:

Probiotic Intervention for Acute Stress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03284905
• Other study ID #: SP17
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: April 4, 2018

Study information

• Verified date: March 2019
• Source: Probi AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Efficacy of probiotics on acute stress

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 4, 2018
• Est. primary completion date: April 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress

Intervention

Dietary Supplement:
• Probiotic supplement
Capsule containing freeze dried probiotic bacteria together with maize starch
• Placebo supplement
Capsule containing maize starch

Locations

Country	Name	City	State
Sweden	Department of Food Technology, Engineering and Nutrition, Lund University	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Probi AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of the cortisol level during acute stress		2.5 hours