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L. Reuteri ATCC PTA 5289 & L. Reuteri DSM 17938 for the Treatment of Children With Pharyngitis and/or Tonsillitis

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ClinicalTrials.gov Identifier: NCT03377374
Recruitment Status : Not yet recruiting
First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Pedro Gutierrez Castrellon, Innovacion y Desarrollo de Estrategias en Salud

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

Condition or disease Intervention/treatment Phase
Pharyngitis Tonsillitis Dietary Supplement: Probiotic Other: Placebo Not Applicable

Detailed Description:

Rationale. Acute respiratory infections (ARIs) are a common problem in the first decade of life. The yearly prevalence of respiratory tract infections in an otherwise healthy 3-year old child is about three to 10 infections. Children between 6 months and 5 years are more prone to develop pharyngitis and tonsillitis compared to older children. 60-70% of children with F/T lies within this age group. Aetiology the pharyngitis and tonsillitis is viral in 70% of all cases In developing countries 6/10 cases are treated using antibiotics, regardless of clinical guidelines or standard of care documents recommending only to use symptomatic drugs (NSAID).

Primary outcome. Duration of symptoms and reduction of pain (odynophagia) severity Secondary outcomes. Days with fever secondary to RTIs; Number of children receiving antibiotic treatment in each treatment group; Days of medical office visits or emergency visits; Total amount of medical office visits or emergency visits during the study, secondary to episodes of RTI; Days of absences from day care centre; Direct and Indirect costs Total costs of treatments including visit to private office, visit to emergency department, cost of treatment (NSAIDs + Probiotics vs NSAIDs + Placebo); Frequency of adverse events; Viral/bacterial load (multiplex-PCR); IgA in saliva and Change in salivary inflammatory biomarkers.

Interventions. L. reuteri DSM 17938 + L. reuteri ATCC PTA 5289) will be given 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) giving a daily dose of 4x108 CFU/day. The placebo drops will have identical ingredients except for lacking the bacteria. Five drops are to be taken twice a day (in the morning and in the evening).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial, double blind allocation concealment, parallel assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Randomization list will by assembled by independient organization not related with participant, care provider, investigators or sponsors. eCRF will include randomization selection
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial on the Safety and Efficacy of L. Reuteri ATCC PTA 5289 & L. Reuteri DSM 17938 for the Treatment of Children With Pharyngitis and/or Tonsillitis: A Proof of Concept
Estimated Study Start Date : December 28, 2017
Estimated Primary Completion Date : May 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Probiotic
L. reuteri ATCC PTA 5289 + L. reuteri DSM 17938 at a dose of 2x10^8 Colony Forming Units (CFU)
Dietary Supplement: Probiotic
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.

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




Primary Outcome Measures :
  1. Clinical Improvement [ Time Frame: 10 days ]
    Duration of respiratory symptoms


Secondary Outcome Measures :
  1. Fever improvement [ Time Frame: 10 days ]
    Total number of hours during the study that the child is with temperature >37.5oC measured twice a day since the moment they start to use the interventions and until the last visit into the study

  2. Use of antibiotics [ Time Frame: 10 days ]
    Total amount of days of antibiotic use during the study, secondary to the presence of episodes of RTI, reported since the beginning of the study products administration until the last visit occur

  3. Medical/Emergency visits [ Time Frame: 10 days ]
    Total amount of medical office visits or emergency visits during the study, secondary to episodes of RTI, reported since the beginning of the study products administration until the last visit occurs

  4. Abseentisim [ Time Frame: 10 days ]
    Total amount of days of absences from the day care centre during the study, secondary to the presence of episodes of RTI, reported since the beginning of the study products administration until the last visit occurs.

  5. Costs of intervention [ Time Frame: 10 days ]
    Total costs of treatments including visit to private office, visit to emergency department, cost of treatment (NSAIDs + Probiotics vs NSAIDs + Placebo)

  6. Adverse events [ Time Frame: 10 days ]
    Total number of adverse events which be reported by parents starting after randomization and finishing at the moment of last visit

  7. Inflammatory improvements [ Time Frame: 10 days ]
    Changes in IgA in saliva



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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Use of antibiotics or probiotic products 2 weeks' prior inclusion in the study
  • 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
  • Supplementation of probiotics 2 weeks before inclusion in the study and during the whole study period
  • If the mother is breastfeeding the child participating in the trial the mother should not use supplementation of probiotics 2 weeks before and during the study period
  • Concurrent participation in other clinical trials

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377374


Contacts
Contact: Pedro G Gutierrez Castrellon, MD, MSc, DSc 525540003000 ext 1246 inpcochrane@gmail.com
Contact: Jose A Maya, Pediatrician 525540003000 jamayab@hotmail.com

Locations
Mexico
Hospital General Dr. Manuel Gea Gonzalez Not yet recruiting
Mexico city, Tlalpan, Mexico, 14080
Contact: Patricia Vidal, MSc    525540003000 ext 3717    vidalv.patricia@gmail.com   
Contact: Cesar Godinez, MSc    525540003000 ext 1426    juce_1313@hotmail.com   
Sponsors and Collaborators
Innovacion y Desarrollo de Estrategias en Salud
Investigators
Principal Investigator: Pedro Gutierrez Castrellon, MD, MSc, DSc Innovacion y Desarrollo de Estrategias en Salud

Publications of Results:

Responsible Party: Pedro Gutierrez Castrellon, Head of Research on Translational Research Center on Mother-Child Health, Innovacion y Desarrollo de Estrategias en Salud
ClinicalTrials.gov Identifier: NCT03377374     History of Changes
Other Study ID Numbers: CSUB0140
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pharyngitis
Tonsillitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases