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Effect of OM-85 on Respiratory Tract Infections and Adenoid Tissue in Children With Adenoid Hypertrophy

NCT03243565 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2017-10-05

No results posted yet for this study

Summary

Clinical research question: Can OM-85 reduce the recurrence of respiratory tract infections (RTIs) in children with AH by stimulating the immunological response of the host and therefore, as a consequence reduce the size of adenoid tissue in children with adenoid hypertrophy? Can this prevent further complications such as surgery need? Half of participants will receive OM-85, while other half will receive a placebo.

Conditions

  • Adenoid Hypertrophy
  • Adenoid Hyperplasia
  • Respiratory Tract Infections
  • Preschool Children

Interventions

BIOLOGICAL

OM-85

OM-85 is an oral bacterial lysate of 21 different strains of 8 species and sub-species of the most common respiratory tract pathogens.

BIOLOGICAL

Placebo

Pregelatinized starch (Starch 1500)+Mannitol+Magnesium stearate+Anhydrous propyl gallate+Sodium glutamate

Sponsors & Collaborators

  • Dr. Sami Ulus Children's Hospital

    lead OTHER

Principal Investigators

  • Serap Ozmen · Health of Science University, Dr Sami Ulus Maternity and Children Research and Training Hospital, Ankara, TURKEY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2019-05-01
Completion
2019-05-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03243565 on ClinicalTrials.gov