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

NACompletedINTERVENTIONAL
Enrollment

222

Participants

Timeline

Start Date

October 2, 2018

Primary Completion Date

July 6, 2020

Study Completion Date

July 6, 2020

Conditions
Acute Otitis Media
Interventions
DIETARY_SUPPLEMENT

Lactobacillus salivarius PS7 during 6 months

7 months intervention study: A 6 months intervention period and 1 month follow-up after intervention finishing time. During the 6 months of intervention the participants will intake one daily dose of the product that contains 1\*10E9 CFU of L. salivarius PS7. Then, a 1 month follow-up period will be completed.

DIETARY_SUPPLEMENT

Lactobacillus salivarius PS7 during 3 months

7 months intervention study: A 6 months intervention period and 1 month follow-up after intervention finishing time. During the 3 months of intervention the participants will intake one daily dose of the product that contains 1\*10E9 CFU of L. salivarius PS7. After that, the participants will intake one daily dose of the placebo. Then, a 1 month follow-up period will be completed.

DIETARY_SUPPLEMENT

placebo

7 months intervention study: A 6 months intervention period and 1 month follow-up after intervention finishing time. During the 6 months of intervention the participants will intake one daily dose of placebo supplement.Then, a 1 month follow-up period will be completed.

Trial Locations (1)

28223

Hospital Universitario QuirónSalud Pozuelo, Pozuelo de Alarcón

All Listed Sponsors
collaborator

Casen Recordati S.L.

INDUSTRY

lead

ProbiSearch SL

INDUSTRY

NCT03614117 - Effect of a New Probiotic Strain on Recurrent Acute Otitis Media in Children (PROMAR) | Biotech Hunter | Biotech Hunter