The Effect of Probiotic and Zinc Supplementation on the Common Cold

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Common Cold
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotic

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden
    • Lunds Universitet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adults

Exclusion Criteria:

• Diagnosed gastrointestinal disorders
• Autoimmune diseases or immuno compromized
• Antibiotic treatment in the last month

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Rice flour	Dietary supplement: Placebo; The participants will consume 2 capsules daily for three months
Active Comparator: Probiotic; Probiotic bacteria, yeast, zinc and rice brand	Dietary supplement: Probiotic; The participants will consume 2 capsules daily for three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms severity	Decrease in the severity of symptoms will be determined using a common cold questionnaire.	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composition of gut and oral microbiome	Change in gut and oral microbiome will be measured using 16SrRNA and 18SrRNA sequencing	Three months
IgA	Changes in levels of IgA in saliva and/or feces will be measured using ELISA	Three months
Duration of symptoms	Decrease in duration of cold will be determined using a common cold questionnaire	Three months
Number of colds	Decrease in number of colds will be determined using a common cold questionnaire	Three months

Collaborators and Investigators

• Sponsor: Lund University
• Collaborators: Coradil AB

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Picornaviridae Infections; Common Cold
• Other Study ID Numbers: Prozicold

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only group data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No