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

Pharyngitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03377374
• Other study ID #: CSUB0140
• Status: Completed
• Phase: N/A
• Start date: December 28, 2017
• Est. completion date: February 11, 2019

Study information

• Verified date: June 2019
• Source: Innovacion y Desarrollo de Estrategias en Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 11, 2019
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharyngitis
• Tonsillitis

Intervention

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.

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

Locations

Country	Name	City	State
Mexico	Hospital General Dr. Manuel Gea Gonzalez	Mexico city	Tlalpan

Sponsors (1)

Lead Sponsor	Collaborator
Innovacion y Desarrollo de Estrategias en Salud

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

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 — View Citation

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

Maldonado J, Cañabate F, Sempere L, Vela F, Sánchez AR, Narbona E, López-Huertas E, Geerlings A, Valero AD, Olivares M, Lara-Villoslada F. Human milk probiotic Lactobacillus fermentum CECT5716 reduces the incidence of gastrointestinal and upper respirator — View Citation

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 s — View Citation

Taipale TJ, Pienihäkkinen K, Isolauri E, Jokela JT, Söderling 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Improvement	Duration of respiratory symptoms	10 days
Secondary	Fever improvement	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	10 days
Secondary	Use of antibiotics	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	10 days
Secondary	Medical/Emergency visits	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	10 days
Secondary	Abseentisim	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.	10 days
Secondary	Costs of intervention	Total costs of treatments including visit to private office, visit to emergency department, cost of treatment (NSAIDs + Probiotics vs NSAIDs + Placebo)	10 days
Secondary	Adverse events	Total number of adverse events which be reported by parents starting after randomization and finishing at the moment of last visit	10 days
Secondary	Inflammatory improvements	Changes in IgA in saliva	10 days