Common ColdNCT04672850
The Effect of Probiotic and Zinc Supplementation on the Common Cold
A study testing Probiotic in people with Common Cold, run by Lund University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Cold
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 27 Jan 2021to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
Who cannot join
- Diagnosed gastrointestinal disorders
- Autoimmune diseases or immuno compromized
- Antibiotic treatment in the last month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Common Cold
- Being tested
- Probiotic, Placebo
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
The participants will consume 2 capsules daily for three months
PlaceboDietary supplement
The participants will consume 2 capsules daily for three months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Rice flour Receives: Dietary Supplement: Placebo |
| Probiotic | Active comparator | Probiotic bacteria, yeast, zinc and rice brand Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms severity
Decrease in the severity of symptoms will be determined using a common cold questionnaire.
Measured: Three months
Secondary outcomes (4)
Composition of gut and oral microbiome
Change in gut and oral microbiome will be measured using 16SrRNA and 18SrRNA sequencing
Measured: Three months
IgA
Changes in levels of IgA in saliva and/or feces will be measured using ELISA
Measured: Three months
Duration of symptoms
Decrease in duration of cold will be determined using a common cold questionnaire
Measured: Three months
Number of colds
Decrease in number of colds will be determined using a common cold questionnaire
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start27 Jan 2021
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Coradil AB
- Responsible party
- Principal investigator, Åsa Håkansson, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672850
- Sponsor's protocol ID
- Prozicold
- Status last verified
- Apr 2022
- First submitted
- 3 Dec 2020
- Last updated
- 12 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only group data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotic and Zinc Supplementation on the Common Cold in Healthy Adults
- ClinicalTrials.gov ID
- NCT04672850
- Acronym / sponsor ID
- Prozicold
- Conditions
- Common Cold
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Coradil AB
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboRice flour |
| Probiotic | Active comparator | Dietary Supplement: ProbioticProbiotic bacteria, yeast, zinc and rice brand |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (3 listed)
- Diagnosed gastrointestinal disorders
- Autoimmune diseases or immuno compromized
- Antibiotic treatment in the last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticThe participants will consume 2 capsules daily for three months | Dietary supplement | Probiotic |
| PlaceboThe participants will consume 2 capsules daily for three months | Dietary supplement | Placebo |
Primary outcome
Symptoms severity
Time frame: Three months
Decrease in the severity of symptoms will be determined using a common cold questionnaire.
4 secondary outcomes
Composition of gut and oral microbiome
Time frame: Three months
IgA
Time frame: Three months
Duration of symptoms
Time frame: Three months
Number of colds
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: No. Only group data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Common Cold, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms severity (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.