NCT04672850

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 27, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

1.8 years

First QC Date

December 3, 2020

Last Update Submit

April 11, 2022

Conditions

Common Cold

Outcome Measures

Primary Outcomes (1)

  • Symptoms severity

    Decrease in the severity of symptoms will be determined using a common cold questionnaire.

    Three months

Secondary Outcomes (4)

  • Composition of gut and oral microbiome

    Three months

  • IgA

    Three months

  • Duration of symptoms

    Three months

  • Number of colds

    Three months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Rice flour

Dietary Supplement: Placebo

Probiotic

ACTIVE COMPARATOR

Probiotic bacteria, yeast, zinc and rice brand

Dietary Supplement: Probiotic

Interventions

ProbioticDIETARY_SUPPLEMENT

The participants will consume 2 capsules daily for three months

Probiotic
PlaceboDIETARY_SUPPLEMENT

The participants will consume 2 capsules daily for three months

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lunds universitet

Lund, Sweden

Location

MeSH Terms

Conditions

Common Cold

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blinded
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

December 3, 2020

First Posted

December 17, 2020

Study Start

January 27, 2021

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

April 12, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Only group data will be shared

Locations

SE(1)