Respiratory Tract InfectionsNCT02687503

Impact of Probiotic Use on Immune Cell Function in Children

A study testing Probiotic in people with Respiratory Tract Infections, run by University of Wisconsin, Madison at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 to 36 months
Conditions the study is for: Respiratory Tract Infections
What is being tested?: Probiotic
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 2 sitesUnited States
Study dates: 15 May 2017to 8 Mar 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 12 to 36 months
All sexes
No healthy volunteers
Child

Who may be able to join

Healthy children greater than 12 months-36 months of age
English speaking parent
Child has not received a live vaccine such as MMR or Varicella in the past 2 weeks

Who cannot join

Asthma/allergic rhinitis
Premature birth (< 36 weeks gestation)
Known to be lactose intolerant
Immunodeficiency or any underlying problem requiring the use of steroids or other immunosuppressive agents
Use of nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen in the last 2 weeks
Currently taking probiotics, have received probiotics in the previous two weeks or are unwilling to refrain from the use of non-study probiotics during the next 30 days

Show all 9Show fewer

Any antibiotic treatment in the last 2 weeks
Conditions which might interfere with dispersion of the probiotic after oral administration such as short gut or anomalies of the digestive tract
Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

UW Health 20 S. Park Clinic
Madison, Wisconsin, 53715
UW Health West Towne Clinic
Madison, Wisconsin, 53717

Other trials in United States

About this study

Probiotics are microorganisms that are believed to provide health benefits when consumed. The term probiotic is currently used to name ingested microorganisms associated with beneficial effects to humans and animals. Probiotics are popularized in the lay literature for many different clinical problems. They have been studied in infants and children as a preventive or treatment for a variety of infections. Studies on the medical benefits of probiotics have yet to reveal a cause-effect relationship, and their medical effectiveness has yet to be conclusively proven for most of the studies conducted thus far. The putative benefit of probiotics in the prevention of infection relates to potential benefits to the innate and adaptive immune systems of infants.

The goals of this investigation are to study immune system cell function and microbiome in children who are taking probiotics.

To accomplish this goal, we propose a pilot study for which we will obtain blood and nasopharyngeal and stool samples prior to and post probiotic use in children greater than 12 months-36 months over a 27-38 day period

Conditions: Respiratory Tract Infections
Being tested: Probiotic
Keywords: Immune system, Probiotics
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.

ProbioticDietary supplement
All children will receive a daily dose of probiotic (10⁹ cfu of L.acidophilus NCFM and B. lactis, Bi-07), a commercially available probiotic. Parents will give probiotic in 1 ounce of milk or water once a day for 30 days in an open label fashion.

Study groups in NCT02687503
Study group	Role	What they receive
Daily dose of probiotic	Other	All children enrolled into the study will receive a daily dose of probiotic Receives: Dietary Supplement: Probiotic

What is being measured

The primary outcome is the main question the study is designed to answer.

Innate immune cell multiparameter flow cytometry assay
The primary measurement will be plasmacytoid dendritic cell responses to various TLR agonists (CpGA, R848) and intact human rhinovirus. Variables measured will include pDC frequency, frequency of IFN-alpha and TNF-alpha producing cells and geometric mean fluorescence intensity of these cytokines using an optimized and standardized multi-parameter flow cytometry assay.
Measured: 3 months

Secondary outcomes (1)

Isolation of peripheral blood mononuclear cells (PBMC) by density gradient
Multi-parameter flow cytometry will be used to determine the frequency of CD25+CD127-/loFoxp3+CD4+ T cells. Function will be indirectly CD25+ determined by quantifying the level of TSDR demethylation in Treg cells.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 May 20178 Mar 2019

First posted22 Feb 2016 (estimated)
Study start15 May 2017
Primary completion29 Nov 2017
Study completion8 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (35)Papers the sponsor has linked to this study.
Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
More trials run by University of Wisconsin, MadisonThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02687503
Sponsor's protocol ID: 2015-0884
Other IDs: A536700, SMPH\PEDIATRICS\PEDIATRICS
Status last verified: Mar 2019
First submitted: 25 Jan 2016
Last updated: 24 Dec 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Olenec JP, Kim WK, Lee WM, Vang F, Pappas TE, Salazar LE, Evans MD, Bork J, Roberg K, Lemanske RF Jr, Gern JE. Weekly monitoring of children with asthma for infections and illness during common cold seasons. J Allergy Clin Immunol. 2010 May;125(5):1001-1006.e1. doi: 10.1016/j.jaci.2010.01.059. Epub 2010 Apr 14.
PubMed 20392488
Hatakka K, Savilahti E, Ponka A, Meurman JH, Poussa T, Nase L, Saxelin M, Korpela R. Effect of long term consumption of probiotic milk on infections in children attending day care centres: double blind, randomised trial. BMJ. 2001 Jun 2;322(7298):1327. doi: 10.1136/bmj.322.7298.1327.
PubMed 11387176
Hojsak I, Abdovic S, Szajewska H, Milosevic M, Krznaric Z, Kolacek S. Lactobacillus GG in the prevention of nosocomial gastrointestinal and respiratory tract infections. Pediatrics. 2010 May;125(5):e1171-7. doi: 10.1542/peds.2009-2568. Epub 2010 Apr 19.
PubMed 20403940
Lin JS, Chiu YH, Lin NT, Chu CH, Huang KC, Liao KW, Peng KC. Different effects of probiotic species/strains on infections in preschool children: A double-blind, randomized, controlled study. Vaccine. 2009 Feb 11;27(7):1073-9. doi: 10.1016/j.vaccine.2008.11.114. Epub 2008 Dec 27.
PubMed 19114073
Maldonado J, Canabate F, Sempere L, Vela F, Sanchez AR, Narbona E, Lopez-Huertas E, Geerlings A, Valero AD, Olivares M, Lara-Villoslada F. Human milk probiotic Lactobacillus fermentum CECT5716 reduces the incidence of gastrointestinal and upper respiratory tract infections in infants. J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):55-61. doi: 10.1097/MPG.0b013e3182333f18.
PubMed 21873895
Merenstein D, Murphy M, Fokar A, Hernandez RK, Park H, Nsouli H, Sanders ME, Davis BA, Niborski V, Tondu F, Shara NM. Use of a fermented dairy probiotic drink containing Lactobacillus casei (DN-114 001) to decrease the rate of illness in kids: the DRINK study. A patient-oriented, double-blind, cluster-randomized, placebo-controlled, clinical trial. Eur J Clin Nutr. 2010 Jul;64(7):669-77. doi: 10.1038/ejcn.2010.65. Epub 2010 May 19.
PubMed 20485304
Taipale T, Pienihakkinen K, Isolauri E, Larsen C, Brockmann E, Alanen P, Jokela J, Soderling E. Bifidobacterium animalis subsp. lactis BB-12 in reducing the risk of infections in infancy. Br J Nutr. 2011 Feb;105(3):409-16. doi: 10.1017/S0007114510003685. Epub 2010 Sep 24.
PubMed 20863419
Luoto R, Ruuskanen O, Waris M, Kalliomaki M, Salminen S, Isolauri E. Prebiotic and probiotic supplementation prevents rhinovirus infections in preterm infants: a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2014 Feb;133(2):405-13. doi: 10.1016/j.jaci.2013.08.020. Epub 2013 Oct 13.
PubMed 24131826
Giovannini M, Agostoni C, Riva E, Salvini F, Ruscitto A, Zuccotti GV, Radaelli G; Felicita Study Group. A randomized prospective double blind controlled trial on effects of long-term consumption of fermented milk containing Lactobacillus casei in pre-school children with allergic asthma and/or rhinitis. Pediatr Res. 2007 Aug;62(2):215-20. doi: 10.1203/PDR.0b013e3180a76d94.
PubMed 17597643
Kukkonen K, Savilahti E, Haahtela T, Juntunen-Backman K, Korpela R, Poussa T, Tuure T, Kuitunen M. Long-term safety and impact on infection rates of postnatal probiotic and prebiotic (synbiotic) treatment: randomized, double-blind, placebo-controlled trial. Pediatrics. 2008 Jul;122(1):8-12. doi: 10.1542/peds.2007-1192.
PubMed 18595980
Leyer GJ, Li S, Mubasher ME, Reifer C, Ouwehand AC. Probiotic effects on cold and influenza-like symptom incidence and duration in children. Pediatrics. 2009 Aug;124(2):e172-9. doi: 10.1542/peds.2008-2666. Epub 2009 Jul 27.
PubMed 19651563
Rautava S, Salminen S, Isolauri E. Specific probiotics in reducing the risk of acute infections in infancy--a randomised, double-blind, placebo-controlled study. Br J Nutr. 2009 Jun;101(11):1722-6. doi: 10.1017/S0007114508116282. Epub 2008 Nov 6.
PubMed 18986600
Rerksuppaphol S, Rerksuppaphol L. Randomized controlled trial of probiotics to reduce common cold in schoolchildren. Pediatr Int. 2012 Oct;54(5):682-7. doi: 10.1111/j.1442-200X.2012.03647.x. Epub 2012 Jul 10.
PubMed 22507276
Sazawal S, Dhingra U, Hiremath G, Sarkar A, Dhingra P, Dutta A, Verma P, Menon VP, Black RE. Prebiotic and probiotic fortified milk in prevention of morbidities among children: community-based, randomized, double-blind, controlled trial. PLoS One. 2010 Aug 13;5(8):e12164. doi: 10.1371/journal.pone.0012164.
PubMed 20730056
Weizman Z, Asli G, Alsheikh A. Effect of a probiotic infant formula on infections in child care centers: comparison of two probiotic agents. Pediatrics. 2005 Jan;115(1):5-9. doi: 10.1542/peds.2004-1815.
PubMed 15629974

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Respiratory Tract Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Probiotic Use on Immune Cell Function in Children
ClinicalTrials.gov ID: NCT02687503
Acronym / sponsor ID: 2015-0884
Conditions: Respiratory Tract Infections
Keywords: Immune system, Probiotics
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Collaborators: Danisco
Study start: 15 May 2017 (actual)
Primary completion: 29 Nov 2017 (actual)
Study completion: 8 Mar 2019 (actual)
First posted: 22 Feb 2016 (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 goals of this investigation are to study immune system cell function and microbiome in children who are taking probiotics.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Daily dose of probiotic	Other	Dietary Supplement: ProbioticAll children enrolled into the study will receive a daily dose of probiotic

Who may qualify

Ages: 12 to 36 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Healthy children greater than 12 months-36 months of age
English speaking parent
Child has not received a live vaccine such as MMR or Varicella in the past 2 weeks

Key exclusion criteria (9 listed)

Asthma/allergic rhinitis
Premature birth (< 36 weeks gestation)
Known to be lactose intolerant
Immunodeficiency or any underlying problem requiring the use of steroids or other immunosuppressive agents
Use of nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen in the last 2 weeks

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
ProbioticAll children will receive a daily dose of probiotic (10⁹ cfu of L.acidophilus NCFM and B. lactis, Bi-07), a commercially available probiotic. Parents will give probiotic in 1 ounce of milk or water once a day for 30 days in an open label fashion.	Dietary supplement	Daily dose of probiotic

Primary outcome

Innate immune cell multiparameter flow cytometry assay
Time frame: 3 months
The primary measurement will be plasmacytoid dendritic cell responses to various TLR agonists (CpGA, R848) and intact human rhinovirus. Variables measured will include pDC frequency, frequency of IFN-alpha and TNF-alpha producing cells and geometric mean fluorescence intensity of these cytokines using an optimized and standardized multi-parameter flow cytometry assay.

1 secondary outcome

Isolation of peripheral blood mononuclear cells (PBMC) by density gradient
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 24 Dec 2019.
Background: PubMed 20392488Olenec JP, Kim WK, Lee WM, Vang F, Pappas TE, Salazar LE, Evans MD, Bork J, Roberg K, Lemanske RF Jr, Gern JE. Weekly monitoring of children with asthma for infections and illness during common cold seasons. J Allergy Clin Immunol. 2010 May;125(5):1001-1006.e1. doi: 10.1016/j.jaci.2010.01.059. Epub 2010 Apr 14.
Background: PubMed 11387176Hatakka K, Savilahti E, Ponka A, Meurman JH, Poussa T, Nase L, Saxelin M, Korpela R. Effect of long term consumption of probiotic milk on infections in children attending day care centres: double blind, randomised trial. BMJ. 2001 Jun 2;322(7298):1327. doi: 10.1136/bmj.322.7298.1327.
Background: PubMed 20403940Hojsak I, Abdovic S, Szajewska H, Milosevic M, Krznaric Z, Kolacek S. Lactobacillus GG in the prevention of nosocomial gastrointestinal and respiratory tract infections. Pediatrics. 2010 May;125(5):e1171-7. doi: 10.1542/peds.2009-2568. Epub 2010 Apr 19.
Background: PubMed 19114073Lin JS, Chiu YH, Lin NT, Chu CH, Huang KC, Liao KW, Peng KC. Different effects of probiotic species/strains on infections in preschool children: A double-blind, randomized, controlled study. Vaccine. 2009 Feb 11;27(7):1073-9. doi: 10.1016/j.vaccine.2008.11.114. Epub 2008 Dec 27.
Background: PubMed 21873895Maldonado J, Canabate F, Sempere L, Vela F, Sanchez AR, Narbona E, Lopez-Huertas E, Geerlings A, Valero AD, Olivares M, Lara-Villoslada F. Human milk probiotic Lactobacillus fermentum CECT5716 reduces the incidence of gastrointestinal and upper respiratory tract infections in infants. J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):55-61. doi: 10.1097/MPG.0b013e3182333f18.
Background: PubMed 20485304Merenstein D, Murphy M, Fokar A, Hernandez RK, Park H, Nsouli H, Sanders ME, Davis BA, Niborski V, Tondu F, Shara NM. Use of a fermented dairy probiotic drink containing Lactobacillus casei (DN-114 001) to decrease the rate of illness in kids: the DRINK study. A patient-oriented, double-blind, cluster-randomized, placebo-controlled, clinical trial. Eur J Clin Nutr. 2010 Jul;64(7):669-77. doi: 10.1038/ejcn.2010.65. Epub 2010 May 19.
Background: PubMed 20863419Taipale T, Pienihakkinen K, Isolauri E, Larsen C, Brockmann E, Alanen P, Jokela J, Soderling E. Bifidobacterium animalis subsp. lactis BB-12 in reducing the risk of infections in infancy. Br J Nutr. 2011 Feb;105(3):409-16. doi: 10.1017/S0007114510003685. Epub 2010 Sep 24.
Background: PubMed 24131826Luoto R, Ruuskanen O, Waris M, Kalliomaki M, Salminen S, Isolauri E. Prebiotic and probiotic supplementation prevents rhinovirus infections in preterm infants: a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2014 Feb;133(2):405-13. doi: 10.1016/j.jaci.2013.08.020. Epub 2013 Oct 13.
Background: PubMed 17597643Giovannini M, Agostoni C, Riva E, Salvini F, Ruscitto A, Zuccotti GV, Radaelli G; Felicita Study Group. A randomized prospective double blind controlled trial on effects of long-term consumption of fermented milk containing Lactobacillus casei in pre-school children with allergic asthma and/or rhinitis. Pediatr Res. 2007 Aug;62(2):215-20. doi: 10.1203/PDR.0b013e3180a76d94.
Background: PubMed 18595980Kukkonen K, Savilahti E, Haahtela T, Juntunen-Backman K, Korpela R, Poussa T, Tuure T, Kuitunen M. Long-term safety and impact on infection rates of postnatal probiotic and prebiotic (synbiotic) treatment: randomized, double-blind, placebo-controlled trial. Pediatrics. 2008 Jul;122(1):8-12. doi: 10.1542/peds.2007-1192.
Background: PubMed 19651563Leyer GJ, Li S, Mubasher ME, Reifer C, Ouwehand AC. Probiotic effects on cold and influenza-like symptom incidence and duration in children. Pediatrics. 2009 Aug;124(2):e172-9. doi: 10.1542/peds.2008-2666. Epub 2009 Jul 27.
Background: PubMed 18986600Rautava S, Salminen S, Isolauri E. Specific probiotics in reducing the risk of acute infections in infancy--a randomised, double-blind, placebo-controlled study. Br J Nutr. 2009 Jun;101(11):1722-6. doi: 10.1017/S0007114508116282. Epub 2008 Nov 6.
Individual participant dataSharing planned: No

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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.

2 sites 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 Respiratory Tract Infections, run by University of Wisconsin, Madison at 2 sites in United States.

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 3 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 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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. 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?

Innate immune cell multiparameter flow cytometry assay (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 NCT02687503, which also lists 35 linked publications.

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 24 Dec 2019.