NCT03377374

Brief Summary

RCT in children (6m to 5y) with pharyngitis and/or tonsillitis who will be allocated to receive for 10 days L. reuteri DSM 17938 + L. reuteri ATCC PTA 5289) at a dose of 2x10\^8 Colony Forming Units (CFU). Five drops are to be taken twice a day (in the morning and in the evening) or placebo drops, as treatment for clinical condition. Duration of symptoms and reduction of pain (odynophagia) severity during treatment will be measured as primary outcome

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 29, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

December 28, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2019

Completed
Last Updated

June 20, 2019

Status Verified

June 1, 2019

Enrollment Period

5 months

First QC Date

November 29, 2017

Last Update Submit

June 18, 2019

Conditions

PharyngitisTonsillitis

Outcome Measures

Primary Outcomes (1)

  • Clinical Improvement

    Duration of respiratory symptoms

    10 days

Secondary Outcomes (7)

  • Fever improvement

    10 days

  • Use of antibiotics

    10 days

  • Medical/Emergency visits

    10 days

  • Abseentisim

    10 days

  • Costs of intervention

    10 days

  • +2 more secondary outcomes

Study Arms (2)

Probiotic

EXPERIMENTAL

L. reuteri ATCC PTA 5289 + L. reuteri DSM 17938 at a dose of 2x10\^8 Colony Forming Units (CFU)

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Five drops of Placebo taken twice a day (in the morning and in the evening).

Other: Placebo

Interventions

ProbioticDIETARY_SUPPLEMENT

L. reuteri Prodentis oil drops (L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289) will be given at a dose of 2x108 Colony Forming Units (CFU). Five drops are to be taken twice a day (in the morning and in the evening) giving a daily dose of 4x108 CFU/day.

Probiotic
PlaceboOTHER

Five drops of Placebo taken twice a day (in the morning and in the evening).

Placebo

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Healthy Infants suffering from pharyngitis and/or tonsillitis
  • Born at term (36 weeks of gestation)
  • Any gender
  • months to 5 years old
  • Birth weight \>2500 g
  • Same socioeconomic background
  • Written informed consent from at least one parent or legal guardian

You may not qualify if:

  • Eight or more new ear infections (otitis media) within 12 months
  • Two or more serious sinus infections within 12 months
  • Two or more episodes of pneumonia within 12 months
  • Two or more invasive infections in the history (meningitis, cellulitis, osteomyelitis, septicaemia)
  • Failure to gain weight or grow normally
  • Chronic diarrhoea
  • Recurrent deep skin or organ abscesses,
  • Persistent superficial candidiasis after 1 year of age
  • Use of two or more months on antibiotics for respiratory infections on the last year before considered eligible
  • Gastroesophageal reflux
  • Allergy
  • Asthma
  • A1-antitrypsin deficeincy
  • Primary or secondary ciliary dyskenisia
  • Congenital anomalies of respiratory tract
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Dr. Manuel Gea Gonzalez

Mexico City, Tlalpan, 14080, Mexico

Location

Related Publications (5)

  • Laursen RP, Larnkjaer A, Ritz C, Hauger H, Michaelsen KF, Molgaard C. Probiotics and Child Care Absence Due to Infections: A Randomized Controlled Trial. Pediatrics. 2017 Aug;140(2):e20170735. doi: 10.1542/peds.2017-0735. Epub 2017 Jul 3.

    PMID: 28674113RESULT

  • Gerasimov SV, Ivantsiv VA, Bobryk LM, Tsitsura OO, Dedyshin LP, Guta NV, Yandyo BV. Role of short-term use of L. acidophilus DDS-1 and B. lactis UABLA-12 in acute respiratory infections in children: a randomized controlled trial. Eur J Clin Nutr. 2016 Apr;70(4):463-9. doi: 10.1038/ejcn.2015.171. Epub 2015 Oct 14.

    PMID: 26463725RESULT

  • Taipale TJ, Pienihakkinen K, Isolauri E, Jokela JT, Soderling EM. Bifidobacterium animalis subsp. lactis BB-12 in reducing the risk of infections in early childhood. Pediatr Res. 2016 Jan;79(1-1):65-9. doi: 10.1038/pr.2015.174. Epub 2015 Sep 15.

    PMID: 26372517RESULT

  • 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.

    PMID: 21873895RESULT

  • 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.

    PMID: 20485304RESULT

MeSH Terms

Conditions

PharyngitisTonsillitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Pedro Gutierrez Castrellon, MD, MSc, DSc

    Innovacion y Desarrollo de Estrategias en Salud

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Randomization list will by assembled by independient organization not related with participant, care provider, investigators or sponsors. eCRF will include randomization selection
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial, double blind allocation concealment, parallel assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research on Translational Research Center on Mother-Child Health

Study Record Dates

First Submitted

November 29, 2017

First Posted

December 19, 2017

Study Start

December 28, 2017

Primary Completion

May 30, 2018

Study Completion

February 11, 2019

Last Updated

June 20, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)