CompletedNot Applicable

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

Spain222 participantsStarted 2018-10-02

Plain-language summary

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.

Who can participate

Age range

1 Year – 4 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children 1 to 4 years of age with rAOM (3 episodes of AOM in the last 6 months, or 4 in the last 12 months). * Written informed consent signed by one of parents or legal guardian with the express or tacit consent of the other. * Presence of an AOM episode at the time of inclusion in the study. Exclusion Criteria: * chronic conditions under regular medication, such as asthma, allergic rhinitis… * congenital or acquired immunodeficiency, * taking systemic corticoid in the last 3 months for longer than 1 month * under present prophylactic antibiotic treatment * Down syndrome, * cleft lip or palate, * chronic tympanic perforation, * craniofacial abnormalities, * sleep apnea syndrome, * planned tympanostomy or tonsillectomy during the months of the study, * short bowel syndrome or any surgery in the gastrointestinal tract, * intestinal epithelial barrier defect (e.g., chronic diarrhea, intestinal inflammation), * metabolic disorders (diabetes, etc.), * heart failure and cardiac medical history (e.g. artificial heart valve, medical history of infective endocarditis, rheumatic fever or cardiac malformation), * uncertainty of the investigator regarding the willingness or capacity of the parents or legal guardian of the child to comply with the requirements of the protocol.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of AOM episodes

Timeframe: 7 months

Trial details

NCT IDNCT03614117

SponsorProbiSearch SL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-07-06

View on ClinicalTrials.gov More Acute Otitis Media trials