Infections, Upper Respiratory TractPIP-UNCT03636191
The Effect of a Probiotic on Upper Respiratory Tract Infections
A study testing Probiotic strain in people with Infections, Upper Respiratory Tract, run by Chr Hansen at 1 site in United Kingdom.
Trial summary
This study is a randomized, double-blind, placebo-controlled, two-armed, parallel-group study in healthy children aged 2-6 years. The study will investigate the effect of daily intake of a probiotic on Upper Respiratory Tract Infections (URTI) during a 16-week intervention. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Upper Respiratory Tract
- What is being tested?
- Probiotic strain
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 619 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2018to 30 Aug 2019
- 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 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 2-6 years, both inclusive, at the time of informed consent
- No URTI at the time of inclusion as assessed by a GP
- Attending day-care with at least 10 children or primary school with at least 10 children in the class for at least 20 hours a week
- Generally healthy as determined by a GP
- Guardian consents to participate in the study and to comply with all its procedures
Who cannot join
- Any known concomitant chronic infections, chronic systemic diseases, autoimmune diseases (e.g. asthma), immunodeficiency, metabolic diseases, chronic respiratory tract diseases including respiratory allergies and cystic fibrosis, congenital cardiac defects.
- Suspected or challenge-proved food allergy
- Use of any prescribed immune suppressive medications at enrolment
- Use of oral or IV antibiotics in the 1 month before randomisation
- Not willing to exclude pre/pro/synbiotics during the study
- Intake of Echinacea, high dose vitamins or Zinc four weeks before and during the study period.
Show all 9Show fewer
- Language limitations regarding interviews or questionnaires
- Participation in other clinical studies in the last 2 months
- Planning extensive travel (for >1 month) during the duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Lactobacillus Rhamnosus (LGG®) on the Defence Against Pathogens in the Upper Respiratory Tract in Healthy Children - a Single-center, Randomized, Double-blind, Placebo-controlled Study With 16 Weeks Intervention.
This study is a randomized, double-blind, placebo-controlled, two-armed, parallel-group study in healthy children aged 2-6 years. The study will investigate the effect of daily intake of a probiotic on Upper Respiratory Tract Infections (URTI) during a 16-week intervention.
- Conditions
- Infections, Upper Respiratory Tract
- Being tested
- Probiotic strain, Placebo
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic strainDietary supplement
Lactobacillus
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Not described Receives: Dietary Supplement: Probiotic strain |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of URTI
The incidence of URTI measured as the number of URTI episodes diagnosed by a GP according to the prespecified, well-defined criteria, adjusted for sample size.
Measured: 16 weeks
Secondary outcomes (6)
The incidence of URTI with pathogens
The incidence of URTI measured as the number of URTI episodes diagnosed by a GP according to the prespecified, well-defined criteria, for which a pathogen is identified in nasal swabs, adjusted for sample size.
Measured: 16 weeks
The Number of days with URTI symptoms
The number of days with URTI symptoms for URTIs that were diagnosed by a GP, adjusted for sample size.
Measured: 16 weeks
The number of days with temperature ≥ 38 °C
The number of days with temperature ≥ 38 °C during an URTI episode, which was diagnosed by a GP, adjusted for sample size.
Measured: 16 weeks
WURSS-K score
The Area under Curve for daily Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K) score (range: not sick - very sick) during an URTI episode, which was diagnosed by a GP, adjusted for sample size.
Measured: 16 weeks
The number of subjects with one or more episode of URTI
The number of subjects with one or more episode of URTI, which was diagnosed by a GP, adjusted for sample size.
Measured: 16 weeks
The number of days of absence from daycare or primary school
The number of days of absence from daycare or primary school during an URTI, which was diagnosed by a GP, adjusted for sample size.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Sep 2018
- Primary completion13 Apr 2019
- Study completion30 Aug 2019
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 Infections, 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 619 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chr Hansen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Onorach Clinical, CPS Research
- Responsible party
- Sponsor
- Investigators
- Gordon Crawford, DRCOG, Principal investigator, CPS Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636191
- Sponsor's protocol ID
- HND-IM-030
- Acronym
- PIP-U
- Status last verified
- Jul 2020
- First submitted
- 16 Aug 2018
- Last updated
- 10 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Damholt A, Keller MK, Baranowski K, Brown B, Wichmann A, Melsaether C, Eskesen D, Westphal V, Arltoft D, Habicht A, Gao Q, Crawford G. Lacticaseibacillus rhamnosus GG DSM 33156 effects on pathogen defence in the upper respiratory tract: a randomised, double-blind, placebo-controlled paediatric trial. Benef Microbes. 2022 Feb 28;13(1):13-23. doi: 10.3920/BM2021.0065. Epub 2021 Dec 13.
PubMed 34895109
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lactobacillus Rhamnosus (LGG®) on the Defence Against Pathogens in the Upper Respiratory Tract in Healthy Children - a Single-center, Randomized, Double-blind, Placebo-controlled Study With 16 Weeks Intervention.
- ClinicalTrials.gov ID
- NCT03636191
- Acronym / sponsor ID
- PIP-U / HND-IM-030
- Conditions
- Infections, Upper Respiratory Tract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 619 participants (actual)
- Lead sponsor
- Chr HansenIndustry (pharma, biotech, devices)
- Collaborators
- Onorach Clinical, CPS Research
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 13 Apr 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 17 Aug 2018 (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.
This study is a randomized, double-blind, placebo-controlled, two-armed, parallel-group study in healthy children aged 2-6 years. The study will investigate the effect of daily intake of a probiotic on Upper Respiratory Tract Infections (URTI) during a 16-week intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Probiotic strain |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 2-6 years, both inclusive, at the time of informed consent
- No URTI at the time of inclusion as assessed by a GP
- Attending day-care with at least 10 children or primary school with at least 10 children in the class for at least 20 hours a week
- Generally healthy as determined by a GP
- Guardian consents to participate in the study and to comply with all its procedures
Key exclusion criteria (9 listed)
- Any known concomitant chronic infections, chronic systemic diseases, autoimmune diseases (e.g. asthma), immunodeficiency, metabolic diseases, chronic respiratory tract diseases including respiratory allergies and cystic fibrosis, congenital cardiac defects.
- Suspected or challenge-proved food allergy
- Use of any prescribed immune suppressive medications at enrolment
- Use of oral or IV antibiotics in the 1 month before randomisation
- Not willing to exclude pre/pro/synbiotics during the study
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 strainLactobacillus | Dietary supplement | Probiotic |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
The incidence of URTI
Time frame: 16 weeks
The incidence of URTI measured as the number of URTI episodes diagnosed by a GP according to the prespecified, well-defined criteria, adjusted for sample size.
6 secondary outcomes
The incidence of URTI with pathogens
Time frame: 16 weeks
The Number of days with URTI symptoms
Time frame: 16 weeks
The number of days with temperature ≥ 38 °C
Time frame: 16 weeks
WURSS-K score
Time frame: 16 weeks
The number of subjects with one or more episode of URTI
Time frame: 16 weeks
The number of days of absence from daycare or primary school
Time frame: 16 weeks
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 10 Jul 2020.
- Derived from this study: PubMed 34895109Damholt A, Keller MK, Baranowski K, Brown B, Wichmann A, Melsaether C, Eskesen D, Westphal V, Arltoft D, Habicht A, Gao Q, Crawford G. Lacticaseibacillus rhamnosus GG DSM 33156 effects on pathogen defence in the upper respiratory tract: a randomised, double-blind, placebo-controlled paediatric trial. Benef Microbes. 2022 Feb 28;13(1):13-23. doi: 10.3920/BM2021.0065. Epub 2021 Dec 13.
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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.
Gordon Crawford, DRCOG principal investigator
CPS Research
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 strain in people with Infections, Upper Respiratory Tract, run by Chr Hansen at 1 site in United Kingdom.
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 5 inclusion and 9 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 10 Jul 2020. 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 United Kingdom. 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?
The incidence of URTI (time frame: 16 weeks). 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 NCT03636191, 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 10 Jul 2020.