The Effect of Probiotic and Zinc Supplementation on the Common Cold

Not Applicable

• Conditions: Common Cold
• Interventions: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

• Registration Number: NCT04672850
• Lead Sponsor: Lund University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-17
• Study Start: 2021-01-27
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-12
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Healthy adults

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	Probiotic bacteria, yeast, zinc and rice brand
Placebo	Placebo	Rice flour

Primary Outcome Measures

Name	Time	Method
Symptoms severity	Three months	Decrease in the severity of symptoms will be determined using a common cold questionnaire.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lunds universitet; 🇸🇪 Lund, Sweden