PROBISEARCH, leading company in probiotic research, has recently finished recruiting the 222 participants as planned for the PROMAR study. This is a randomized, double blind, placebo-controlled clinical trial to evaluate the effect of Lactobacillus salivarius PS7 strain on recurrent Acute Otitis Media (rAOM) in babies.
Acute Otitis Media (AOM) is an inflammatory process of the middle ear that is characterized by the sudden onset of one or more local or systemic symptoms of inflammation in the middle ear, including ear pain or painful pull of the ear in infants and babies, ear discharge, fever, irritability, anorexia, vomiting and diarrhea. If there are three or more episodes of AOM in a six-month period or four episodes in one year with periods of total recovery, with no liquid discharge in the middle ear, between each episode, this is considered to be recurrent AOM (rAOM).
The most common pathogens associated with OAM are Streptococcus pneumoniae, Haemophilus influenzae and Moraxella.
Peak OAM incidence happens at 6-24 months of age. Nearly 50% of babies will develop an episode of OAM at 3-6 months old. It is estimated that before the age of 3, 50% to 85% of babies will have an episode of OAM and before the age of 5, 30% of the babies has rOAM.
The primary objective of PROMAR is to investigate the effect of the new probiotic strain Lactobacillus salivarius PS7 on the incidence of episodes of acute otitis media in children with recurrent Acute Otitis Media (rOAM) during the period of intervention.
Additionally the study is also intended to investigate the number of OAM episodes 3 months after intervention, number of OAM episodes at the 7 month follow-up, duration and severity of Acute Otitis Media (AOM) episodes among participating babies, and the presence of pathogenic strains in the ear mucosa of babies with rOAM, as well as the incidence and duration of otitis externa and other infections in the upper respiratory tract.
This study involves 68 participating researchers from 24 public and private institutions in different autonomous regions in Spain.
PROBISEARCH has a Clinical Trial Department with expertise in the design, implementation, development and follow-up of clinical trials with probiotics. Trials are conducted in accordance with local and international Good Clinical Practices.
PROBISEARCH is located in Madrid Technology Park. Founded in 2011 by a group of scientists from the Complutense University of Madrid, PROBISEARCH’s mission is to offer new probiotic products to prevent and treat a range of human and animal diseases where the microbiota plays a role.
PROBISEARCH was acquired in 2016 by biotechnology group Zendal with the aim of continuing with this mission and integrating this knowledge and expertise within a more wide-ranging offering in the field of Probiotics for human and animal health.