NCT06205966

Brief Summary

This study investigates the effect of Lactobacillus reuteri probiotic strains (ATCC PTA 5289 and DSM 17938) on symptoms of viral upper-respiratory tract infections in children.

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
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable

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

Study Start

First participant enrolled

December 21, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 2, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 16, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

January 16, 2024

Status Verified

January 1, 2024

Enrollment Period

1.9 years

First QC Date

January 2, 2024

Last Update Submit

January 11, 2024

Conditions

Virus Diseases in Children

Outcome Measures

Primary Outcomes (1)

  • Time to healing, defined as number of hours until absence of symptoms (fever, runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired) as well as absence of use of Non-steroidal anti-inflammatory drugs (NSAIDs)

    10 days

Secondary Outcomes (8)

  • Duration of symptoms (runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired)

    10 days

  • Severity of symptoms (runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired) recorded in a "Symptom Diary".

    10 days

  • Duration of fever, defined as the total number of hours that the child has a core temperature >38oC measured twice per day.

    10 days

  • Amount of NSAIDs used.

    10 days

  • Number of children receiving antibiotic treatment in each treatment group.

    10 days

  • +3 more secondary outcomes

Study Arms (2)

Probiotics

ACTIVE COMPARATOR

Study product containing L. reuteri (PTA5289 and DSM 17938) taken orally once in the morning and once in the evening, each time 5 drops.

Dietary Supplement: BioGaia Pharax (L. reuteri PTA 5289 and DSM 17938)

Placebo

PLACEBO COMPARATOR

Placebo taken orally once in the morning and once in the evening, each time 5 drops.

Other: Placebo

Interventions

BioGaia Pharax (L. reuteri PTA 5289 and DSM 17938)DIETARY_SUPPLEMENT

BioGaia Pharax drops (with PTA5289 and DSM 17938) with vitamin D3 will be manufactured and delivered by BioGaia AB as oil suspension.

Probiotics
PlaceboOTHER

Placebo product contains vitamin D3 and is identical to the active product but lacks L. reuteri.

Placebo

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with symptoms of upper respiratory tract infection (coughing/fever/sneezing/runny or congested nose/pharynx pain)
  • Any gender
  • Age from 4 years to 17 years
  • Signing a informed consent form by at least one parent, foster parent or guardian after patient information and by children aged over 6 years
  • Negative Strep test

You may not qualify if:

  • Use of antibiotics or probiotics in the 10 days prior to study enrolment
  • Use of a probiotic other than the test sample during the study
  • Eight or more otitis media within 12 months
  • Two or more bacterial sinusitis within 12 months
  • Two or more pneumonia episodes within 12 months
  • History of two or more invasive infections (meningitis, cellulitis, osteomyelitis, septicaemia)
  • Chronic diarrhea
  • Recurrent deep skin or organ abscesses
  • Persistent superficial candidiasis
  • Use of antibiotics for two months or more to treat respiratory infections within 12 months
  • Gastroesophageal reflux
  • Perennial (e.g., dust mite or mold) or current seasonal hay fever allergy
  • Primary or secondary ciliary dyskinesia
  • Congenital malformations of the respiratory tract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Szent Miklós Szolgálat Kft.

Szigetszentmiklós, Pest County, 2310, Hungary

RECRUITING

Related Publications (1)

  • Maya-Barrios A, Lira-Hernandez K, Jimenez-Escobar I, Hernandez L, Ortiz-Hernandez A, Jimenez-Gutierrez C, Lopez-Velazquez G, Gutierrez-Castrellon P. Limosilactobacillus reuteri ATCC PTA 5289 and DSM 17938 as adjuvants to improve evolution of pharyngitis/tonsillitis in children: randomised controlled trial. Benef Microbes. 2021 Apr 12;12(2):137-145. doi: 10.3920/BM2020.0171. Epub 2021 Apr 1.

    PMID: 33789556BACKGROUND

Central Study Contacts

Gergely Milosevits, MD, PhD

CONTACT

+36308425722drgergelymilosevits@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 2, 2024

First Posted

January 16, 2024

Study Start

December 21, 2023

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

January 16, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)