The Effect of Probiotic and Zinc Supplementation on the Common Cold
Primary Purpose
Common Cold
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Common Cold
Eligibility Criteria
Inclusion Criteria:
- Healthy adults
Exclusion Criteria:
- Diagnosed gastrointestinal disorders
- Autoimmune diseases or immuno compromized
- Antibiotic treatment in the last month
Sites / Locations
- Lunds universitet
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Probiotic
Arm Description
Rice flour
Probiotic bacteria, yeast, zinc and rice brand
Outcomes
Primary Outcome Measures
Symptoms severity
Decrease in the severity of symptoms will be determined using a common cold questionnaire.
Secondary Outcome Measures
Composition of gut and oral microbiome
Change in gut and oral microbiome will be measured using 16SrRNA and 18SrRNA sequencing
IgA
Changes in levels of IgA in saliva and/or feces will be measured using ELISA
Duration of symptoms
Decrease in duration of cold will be determined using a common cold questionnaire
Number of colds
Decrease in number of colds will be determined using a common cold questionnaire
Full Information
NCT ID
NCT04672850
First Posted
December 3, 2020
Last Updated
April 11, 2022
Sponsor
Lund University
Collaborators
Coradil AB
1. Study Identification
Unique Protocol Identification Number
NCT04672850
Brief Title
The Effect of Probiotic and Zinc Supplementation on the Common Cold
Official Title
The Effect of Probiotic and Zinc Supplementation on the Common Cold in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University
Collaborators
Coradil AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double-blinded
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Rice flour
Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
Probiotic bacteria, yeast, zinc and rice brand
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
The participants will consume 2 capsules daily for three months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
The participants will consume 2 capsules daily for three months
Primary Outcome Measure Information:
Title
Symptoms severity
Description
Decrease in the severity of symptoms will be determined using a common cold questionnaire.
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Composition of gut and oral microbiome
Description
Change in gut and oral microbiome will be measured using 16SrRNA and 18SrRNA sequencing
Time Frame
Three months
Title
IgA
Description
Changes in levels of IgA in saliva and/or feces will be measured using ELISA
Time Frame
Three months
Title
Duration of symptoms
Description
Decrease in duration of cold will be determined using a common cold questionnaire
Time Frame
Three months
Title
Number of colds
Description
Decrease in number of colds will be determined using a common cold questionnaire
Time Frame
Three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adults
Exclusion Criteria:
Diagnosed gastrointestinal disorders
Autoimmune diseases or immuno compromized
Antibiotic treatment in the last month
Facility Information:
Facility Name
Lunds universitet
City
Lund
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Only group data will be shared
Learn more about this trial
The Effect of Probiotic and Zinc Supplementation on the Common Cold
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