Acute Otitis MediaPROMARNCT03614117
Effect of a New Probiotic Strain on Recurrent Acute Otitis Media in Children (PROMAR)
A study testing Lactobacillus salivarius PS7 during 6 months and Lactobacillus salivarius PS7 during 3 months in people with Acute Otitis Media, run by ProbiSearch SL at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 4 years
- Conditions the study is for
- Acute Otitis Media
- What is being tested?
- Lactobacillus salivarius PS7 during 6 months and Lactobacillus salivarius PS7 during 3 months
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 1 siteSpain
- Study dates
- 2 Oct 2018to 6 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario QuirónSalud Pozuelo
Pozuelo de Alarcón, Madrid, 28223
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of a Probiotic on Recurrent Acute Otitis Media (rAOM) in Children
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.
Read the detailed description
The parent or legal guardian of the minors will be contacted during a visit to the pediatrician for suspected AOM to request their participation in the study, which will be voluntary.
The study visits will take place at the primary care center or hospital. During Visit 1, the inclusion and exclusion criteria will be verified, and the informed consent will be signed. Information will be collected on the demographic profile, characteristics of the AOM episode and the prescribed treatment; and the participants will be randomized. The investigator will give the parent or guardian the product corresponding to the first treatment period (3 months) and will explain how to administer it to the child, as well as when the next visits will take place and what they will entail. Instructions will be given to start the administration of the product as soon as possible after the collection of the first stool sample. A sample will be collected from the outer ear most affected by the AOM using a sterile swab (Day 0). The investigator will go over, with the parent or legal guardian, the details of the diary to be completed (Annex II), how to record the data on product administration, fever episodes, days of school or daycare missed, unscheduled visits to the pediatrician, as well as data related to the frequency and characteristics of the stools in the event of AOM episodes and/or antibiotic treatment. The investigator will inform the parent or legal guardian that, during the child's participation in the study, the child cannot take any probiotic supplement.
During Visit 2, a sample will be taken from the same ear as in the previous visit using a sterile swab. Any questions regarding completing the diary will be discussed. The leftover product from the first treatment period will be collected and the study product corresponding to the second supplement administration period will be dispensed.
At the third visit (Visit 3, after 6 months of product administration), a sample will be collected from the same ear as in previous visits using a sterile swab. Any leftover product from the second treatment period will be collected.
During the fourth visit (Visit 4, after 1 month of observation), a sample will be collected from the same ear as in previous visits using a sterile swab. The completed diary will be collected.
Throughout the duration of the child's participation in the study (7 months), additional visits to the pediatrician (study investigator) may take place. If an episode of AOM, otitis externa or respiratory tract infection occurs during the intervention period, the investigator will make a diagnosis and will start the necessary treatment. In the course of new AOM episodes, during the intervention period, the administration of the product will not be interrupted. If the AOM episode occurs during the observation period, the investigator will proceed according to his/her routine practice. At the additional visits taking place, relevant data will be collected on the possible Adverse Events (AEs) or Serious Adverse Events (SAEs), as well as on the concomitant medication.
- Conditions
- Acute Otitis Media
- Being tested
- Lactobacillus salivarius PS7 during 6 months, Lactobacillus salivarius PS7 during 3 months, placebo
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus salivarius PS7 during 6 monthsDietary supplement
Also called Lactobacillus salivarius CECT9422 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.
Lactobacillus salivarius PS7 during 3 monthsDietary supplement
Also called Lactobacillus salivarius CECT9422 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.
placeboDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| L.salivarius PS7 6-months | Active comparator | Lactobacillus salivarius PS7 during 6-months; approximately 1*10E9 colony forming unit (CFU) of L. salivarius PS7 in 1 sachet per day to be diluted in water by mouth for 6-months. Receives: Dietary Supplement: Lactobacillus salivarius PS7 during 6 months |
| L. salivarius PS7 + placebo (3+3) | Active comparator | Lactobacillus salivarius PS7 during 3 months; approximately 1*10E9 CFU of L. salivarius PS7 in 1 sachet per day to be diluted in water by mouth for 3-months followed by 3 months oral administration of 1sachet per day of placebo supplement to be diluted in water. Receives: Dietary Supplement: Lactobacillus salivarius PS7 during 3 months |
| Control group | Placebo comparator | Placebo supplement in 1 sachet per day to be diluted in water by mouth for 6-months. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of AOM episodes
Number of AOM episodes suffered by participants
Measured: 7 months
Secondary outcomes (4)
Patients (%) with at least one AOM episode during the intervention and follow-up periods.
% of patients with at least one AOM episode
Measured: 7 months
Number of AOM episodes after 3 months of product intake.
Number of AOM episodes suffered by participants after 3 months of product intake
Measured: 3 months
Time from onset of first AOM episode to the onset of the next episode.
Number of days from onset of first AOM episode to the onset of the next episode.
Measured: 7 months
Adverse events and/or serious adverse events
The number, duration and possible relationship of (serious) adverse events to the study product.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start2 Oct 2018
- Primary completion6 Jul 2020
- Study completion6 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an interventional, randomized, double-blind, placebo-controlled, parallel-group study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProbiSearch SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Casen Recordati S.L.
- Responsible party
- Sponsor
- Investigators
- Susana Manzano, PhD, Study chair, ProbiSearch SL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614117
- Sponsor's protocol ID
- OTR/17.01
- Acronym
- PROMAR
- Status last verified
- Oct 2020
- First submitted
- 30 Jul 2018
- Last updated
- 22 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of a Probiotic on Recurrent Acute Otitis Media (rAOM) in Children
- ClinicalTrials.gov ID
- NCT03614117
- Acronym / sponsor ID
- PROMAR / OTR/17.01
- Conditions
- Acute Otitis Media
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- ProbiSearch SLIndustry (pharma, biotech, devices)
- Collaborators
- Casen Recordati S.L.
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 6 Jul 2020 (actual)
- Study completion
- 6 Jul 2020 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The parent or legal guardian of the minors will be contacted during a visit to the pediatrician for suspected AOM to request their participation in the study, which will be voluntary.
The study visits will take place at the primary care center or hospital. During Visit 1, the inclusion and exclusion criteria will be verified, and the informed consent will be signed. Information will be collected on the demographic profile, characteristics of the AOM episode and the prescribed treatment; and the participants will be randomized. The investigator will give the parent or guardian the product corresponding to the first treatment period (3 months) and will explain how to administer it to the child, as well as when the next visits will take place and what they will entail. Instructions will be given to start the administration of the product as soon as possible after the collection of the first stool sample. A sample will be collected from the outer ear most affected by the AOM using a sterile swab (Day 0). The investigator will go over, with the parent or legal guardian, the details of the diary to be completed (Annex II), how to record the data on product administration, fever episodes, days of school or daycare missed, unscheduled visits to the pediatrician, as well as data related to the frequency and characteristics of the stools in the event of AOM episodes and/or antibiotic treatment. The investigator will inform the parent or legal guardian that, during the child's participation in the study, the child cannot take any probiotic supplement.
During Visit 2, a sample will be taken from the same ear as in the previous visit using a sterile swab. Any questions regarding completing the diary will be discussed. The leftover product from the first treatment period will be collected and the study product corresponding to the second supplement administration period will be dispensed.
At the third visit (Visit 3, after 6 months of product administration), a sample will be collected from the same ear as in previous visits using a sterile swab. Any leftover product from the second treatment period will be collected.
During the fourth visit (Visit 4, after 1 month of observation), a sample will be collected from the same ear as in previous visits using a sterile swab. The completed diary will be collected.
Throughout the duration of the child's participation in the study (7 months), additional visits to the pediatrician (study investigator) may take place. If an episode of AOM, otitis externa or respiratory tract infection occurs during the intervention period, the investigator will make a diagnosis and will start the necessary treatment. In the course of new AOM episodes, during the intervention period, the administration of the product will not be interrupted. If the AOM episode occurs during the observation period, the investigator will proceed according to his/her routine practice. At the additional visits taking place, relevant data will be collected on the possible Adverse Events (AEs) or Serious Adverse Events (SAEs), as well as on the concomitant medication.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is an interventional, randomized, double-blind, placebo-controlled, parallel-group study.
| Arm | Type | Receives |
|---|---|---|
| L.salivarius PS7 6-months | Active comparator | Dietary Supplement: Lactobacillus salivarius PS7 during 6 monthsLactobacillus salivarius PS7 during 6-months; approximately 1*10E9 colony forming unit (CFU) of L. salivarius PS7 in 1 sachet per day to be diluted in water by mouth for 6-months. |
| L. salivarius PS7 + placebo (3+3) | Active comparator | Dietary Supplement: Lactobacillus salivarius PS7 during 3 monthsLactobacillus salivarius PS7 during 3 months; approximately 1*10E9 CFU of L. salivarius PS7 in 1 sachet per day to be diluted in water by mouth for 3-months followed by 3 months oral administration of 1sachet per day of placebo supplement to be diluted in water. |
| Control group | Placebo comparator | Dietary Supplement: placeboPlacebo supplement in 1 sachet per day to be diluted in water by mouth for 6-months. |
Who may qualify
- Ages
- 1 year to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus salivarius PS7 during 6 monthsAlso: Lactobacillus salivarius CECT9422 during 6 months7 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 | L.salivarius PS7 6-months |
| Lactobacillus salivarius PS7 during 3 monthsAlso: Lactobacillus salivarius CECT9422 during 3 months7 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 | L. salivarius PS7 + placebo (3+3) |
| placebo7 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. | Dietary supplement | Control group |
Primary outcome
Number of AOM episodes
Time frame: 7 months
Number of AOM episodes suffered by participants
4 secondary outcomes
Patients (%) with at least one AOM episode during the intervention and follow-up periods.
Time frame: 7 months
Number of AOM episodes after 3 months of product intake.
Time frame: 3 months
Time from onset of first AOM episode to the onset of the next episode.
Time frame: 7 months
Adverse events and/or serious adverse events
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susana Manzano, PhD study chair
ProbiSearch SL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus salivarius PS7 during 6 months and Lactobacillus salivarius PS7 during 3 months in people with Acute Otitis Media, run by ProbiSearch SL at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of AOM episodes (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.