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NCT04672850 Clinical Trial

The Effect of Probiotic and Zinc Supplementation on the Common Cold

Common Cold Clinical Trial

Official title:
The Effect of Probiotic and Zinc Supplementation on the Common Cold in Healthy Adults

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04672850
Other study ID # Prozicold
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date January 27, 2021
Est. completion date November 2022

Study information
Verified date April 2022
Source Lund University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose with this study is to investigate the preventative effect of a supplement containing a combination of probiotic bacteria and fungi as well as zinc on the common cold. The hypothesis is that it will shorten the duration, alleviate the severity of symptoms or even decrease the number of infectons during the intervention period. This study is a randomzed placebo controlled human study were healthy adults will consume the supplement for three months.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 100
Est. completion date November 2022
Est. primary completion date November 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Healthy adults Exclusion Criteria: - Diagnosed gastrointestinal disorders - Autoimmune diseases or immuno compromized - Antibiotic treatment in the last month

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Probiotic
The participants will consume 2 capsules daily for three months
• Placebo
The participants will consume 2 capsules daily for three months

Locations
Country Name City State
Sweden Lunds universitet Lund

Sponsors (2)
Lead Sponsor Collaborator
Lund University Coradil AB

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Symptoms severity Decrease in the severity of symptoms will be determined using a common cold questionnaire. Three months
Secondary Composition of gut and oral microbiome Change in gut and oral microbiome will be measured using 16SrRNA and 18SrRNA sequencing Three months
Secondary IgA Changes in levels of IgA in saliva and/or feces will be measured using ELISA Three months
Secondary Duration of symptoms Decrease in duration of cold will be determined using a common cold questionnaire Three months
Secondary Number of colds Decrease in number of colds will be determined using a common cold questionnaire Three months
See also
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