Viral Infections of the Upper Respiratory TractNCT02013934
Probiotics in Prevention of Common Cold
A study testing Probiotic in people with Viral Infections of the Upper Respiratory Tract, run by Probi AB at 1 site in Germany.
Trial summary
The objective of this study is to assess the benefit and tolerability of a probiotic product in subjects with increased susceptibility to common cold. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Viral Infections of the Upper Respiratory Tract
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 899 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to 17 May 2016
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- males and females
- age 18-70 years
- increased risk for common cold (at least 4 episodes within 12 months)
- commitment to adhere to former diet and physical activity
- commitment not to use any products that may influence the study outcome (e.g. immune suppressants/immune stimulants, including paramedication such as e.g. Echinacea, analgesics/anti-rheumatics, anti-phlogistics, antitussives/expectorants, influenza remedies, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, probiotics) during the study (except for rescue medication, see 7.5)
- women of child-bearing potential have to agree to use appropriate birth control methods Written consent of the subject to participate is a prerequisite for study participation.
Who cannot join
- acute / chronic upper / lower airways disease
- chronic cough of any origin
- any allergic reaction that may influence the study outcome (e.g. acute/chronic rhinitis)
- history of nasal reconstructive surgery
- presence of nasal ulcers or nasal polyps
- severe nasal septum deviation or other condition that could cause nasal obstruction
Show all 23Show fewer
- congenital or acquired immunodeficiency disease (e.g. HIV infection)
- Bechterew's disease
- body temperature above 37.5°C
- suspected swine flu or influenza
- vaccination with a vaccine containing an adjuvant within 3 months prior to study start and during the study
- vaccination with a vaccine not containing an adjuvant within 6 weeks prior to study start and during the study
- stomach/gastrointestinal diseases
- serious organ or systemic diseases
- sleep disorder
- psychiatric disorders
- known sensitivity to the ingredients of the investigational product
- regular intake of products that may influence the study outcome (e.g. immune suppressants/immune stimulants, including paramedication such as e.g. Echinacea, analgesics/anti-rheumatics, anti-phlogistics, antitussives/expectorants, influenza remedies, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, probiotics) within the last 4 weeks prior to study start
- habitual usage of nasal drops/spray
- pregnancy or nursing
- alcohol / drug abuse
- simultaneous participation in another clinical trial or participation in a clinical trial within the last 30 days
- insufficient compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefit and Tolerability of a Probiotic Product in Subjects With Increased Susceptibility to Common Cold
The objective of this study is to assess the benefit and tolerability of a probiotic product in subjects with increased susceptibility to common cold.
- Being tested
- Probiotic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Active comparator | Dietary supplement Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Dietary supplement Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of cold symptoms
Severity of cold symptoms based on the questionnaire WURSS-21 during the cold episodes throughout the study period, in comparison between verum and placebo group
Measured: 3 months
Secondary outcomes (1)
Incidence of common cold episodes
Measured: 3 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 2013 (estimated)
- Study startOct 2013
- Primary completionMay 2016
- Study completion17 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Viral Infections of the Upper Respiratory TractStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 899 participants (actual)
Sponsor and investigators
- Lead sponsor
- Probi AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013934
- Sponsor's protocol ID
- PAB/011013
- Status last verified
- Dec 2013
- First submitted
- 6 Dec 2013
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ahren IL, Hillman M, Nordstrom EA, Larsson N, Niskanen TM. Fewer Community-Acquired Colds with Daily Consumption of Lactiplantibacillus plantarum HEAL9 and Lacticaseibacillus paracasei 8700:2. A Randomized, Placebo-Controlled Clinical Trial. J Nutr. 2021 Jan 4;151(1):214-222. doi: 10.1093/jn/nxaa353.
PubMed 33296464
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit and Tolerability of a Probiotic Product in Subjects With Increased Susceptibility to Common Cold
- ClinicalTrials.gov ID
- NCT02013934
- Acronym / sponsor ID
- PAB/011013
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 899 participants (actual)
- Lead sponsor
- Probi ABIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- May 2016 (actual)
- Study completion
- 17 May 2016 (actual)
- First posted
- 17 Dec 2013 (estimated)
- 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 objective of this study is to assess the benefit and tolerability of a probiotic product in subjects with increased susceptibility to common cold.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Active comparator | Dietary Supplement: ProbioticDietary supplement |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDietary supplement |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- males and females
- age 18-70 years
- increased risk for common cold (at least 4 episodes within 12 months)
- commitment to adhere to former diet and physical activity
- commitment not to use any products that may influence the study outcome (e.g. immune suppressants/immune stimulants, including paramedication such as e.g. Echinacea, analgesics/anti-rheumatics, anti-phlogistics, antitussives/expectorants, influenza remedies, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, probiotics) during the study (except for rescue medication, see 7.5)
Key exclusion criteria (23 listed)
- acute / chronic upper / lower airways disease
- chronic cough of any origin
- any allergic reaction that may influence the study outcome (e.g. acute/chronic rhinitis)
- history of nasal reconstructive surgery
- presence of nasal ulcers or nasal polyps
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 |
|---|---|---|
| Probiotic | Dietary supplement | Probiotics |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Severity of cold symptoms
Time frame: 3 months
Severity of cold symptoms based on the questionnaire WURSS-21 during the cold episodes throughout the study period, in comparison between verum and placebo group
1 secondary outcome
Incidence of common cold episodes
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Derived from this study: PubMed 33296464Ahren IL, Hillman M, Nordstrom EA, Larsson N, Niskanen TM. Fewer Community-Acquired Colds with Daily Consumption of Lactiplantibacillus plantarum HEAL9 and Lacticaseibacillus paracasei 8700:2. A Randomized, Placebo-Controlled Clinical Trial. J Nutr. 2021 Jan 4;151(1):214-222. doi: 10.1093/jn/nxaa353.
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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 Viral Infections of the Upper Respiratory Tract, run by Probi AB at 1 site in Germany.
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 6 inclusion and 23 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: finished, as of the sponsor's last update on 17 Apr 2018. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Severity of cold symptoms (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02013934, which also lists 1 linked publication.
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 17 Apr 2018.