Status:
COMPLETED
L. Reuteri ATCC PTA 5289 & L. Reuteri DSM 17938 for the Treatment of Children With Pharyngitis and/or Tonsillitis
Lead Sponsor:
Innovacion y Desarrollo de Estrategias en Salud
Conditions:
Pharyngitis
Tonsillitis
Eligibility:
All Genders
6-5 years
Phase:
NA
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 (...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03377374
Start Date
December 28 2017
End Date
February 11 2019
Last Update
June 20 2019
Active Locations (1)
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1
Hospital General Dr. Manuel Gea Gonzalez
Mexico City, Tlalpan, Mexico, 14080