NCT03614117

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 2, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2020

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

1.8 years

First QC Date

July 30, 2018

Last Update Submit

October 20, 2020

Conditions

Acute Otitis Media

Outcome Measures

Primary Outcomes (1)

  • Number of AOM episodes

    Number of AOM episodes suffered by participants

    7 months

Secondary Outcomes (4)

  • Patients (%) with at least one AOM episode during the intervention and follow-up periods.

    7 months

  • Number of AOM episodes after 3 months of product intake.

    3 months

  • Time from onset of first AOM episode to the onset of the next episode.

    7 months

  • Adverse events and/or serious adverse events

    7 months

Other Outcomes (1)

  • Variables assessing compliance with the protocol

    7 months

Study Arms (3)

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.

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.

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.

Dietary Supplement: placebo

Interventions

Lactobacillus salivarius PS7 during 6 monthsDIETARY_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 the product that contains 1\*10E9 CFU of L. salivarius PS7. Then, a 1 month follow-up period will be completed.

Also known as: Lactobacillus salivarius CECT9422 during 6 months
L.salivarius PS7 6-months
Lactobacillus salivarius PS7 during 3 monthsDIETARY_SUPPLEMENT

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.

Also known as: Lactobacillus salivarius CECT9422 during 3 months
L. salivarius PS7 + placebo (3+3)
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.

Control group

Eligibility Criteria

Age1 Year - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario QuirónSalud Pozuelo

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Susana Manzano, PhD

    ProbiSearch SL

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is an interventional, randomized, double-blind, placebo-controlled, parallel-group study.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2018

First Posted

August 3, 2018

Study Start

October 2, 2018

Primary Completion

July 6, 2020

Study Completion

July 6, 2020

Last Updated

October 22, 2020

Record last verified: 2020-10

Locations

ES(1)