NCT03614117: PROMAR

Effect of a New Probiotic Strain on Recurrent Acute Otitis Media in Children (PROMAR)

Completed NA Last updated 22 October 2020

What this trial tests

NA trial testing Lactobacillus salivarius PS7 during 6 months in Acute Otitis Media in 222 participants. Completed in 6 July 2020.

Timeline

2 October 2018

Primary endpoint
6 July 2020

6 July 2020

Quick facts

Lead sponsor	ProbiSearch SL
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	222
Start date	2 October 2018
Primary completion	6 July 2020
Estimated completion	6 July 2020
Sites	1 location across Spain

Drugs / interventions tested

• Lactobacillus salivarius PS7 during 6 months
• Lactobacillus salivarius PS7 during 3 months
• placebo

Conditions studied

• Acute Otitis Media — all drugs for Acute Otitis Media →

Sponsor

ProbiSearch SL — full company profile →

Who can join

Adults 1 to 4, any sex, with Acute Otitis Media. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strain Lactobacillus salivarius PS7 on Acute Otitis Media (AOM) in children with recurrent AOM history. The study duration will be 7 months, which includes a 6-month product administration and a 1-month follow-up period. Participants will be randomized assigned to one of the three study groups: the control group; a 3 months probiotic +3 months placebo consumption group and a 6 months probiotic consumption group. The efficacy of the probiotic strain to reduce the incidence of AOM episodes will be assessed by counting AOM episodes occurring in study participants, during the entire intervention and follow-up periods, by bilateral comparison of each of the treatment groups with the control group according to the following hypothesis: "The number of AOM episodes occurring in participants who take the probiotic is the same as that for the participants in the control group. λc = λe". Where λc is the mean incidence of AOM in the control group and λe is the mean incidence of AOM in the groups taking the probiotic strain Lactobacillus salivarius PS7 obtained with 95% confidence interval.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Probiotics for preventing acute otitis media in children.
   Scott AM, Clark J, Julien B, Islam F, et al · · 2019 · cited 20× · PMID 31210358 · DOI 10.1002/14651858.cd012941.pub2