Study on OM-85 for Preventing Respiratory Infections in Children with Wheezing Illness (Ages 6 Months to 5 Years)

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What is this study about?

This clinical trial is focused on studying the prevention of Respiratory Tract Infections in children aged between 6 months and 5 years who experience wheezing with lower respiratory illnesses. The treatment being tested is called OM-85, also known as Broncho-Vaxom, which is a medication made from lyophilized bacterial lysates. This means it contains small parts of bacteria that are processed and dried to help stimulate the immune system. The study will compare the effects of OM-85 with a placebo to see if it can reduce the number of respiratory infections in these children.

The purpose of the study is to assess how effective OM-85 is in preventing these infections over a 12-month period. Children participating in the study will be randomly assigned to receive either the OM-85 treatment or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, to ensure unbiased results. The trial will take place in multiple centers, allowing for a diverse group of participants.

Throughout the study, the health of the children will be closely monitored to track the number of respiratory infections they experience. The goal is to determine if OM-85 can significantly reduce these infections compared to the placebo, providing a potential new way to help children with recurrent respiratory issues. The study will last for a total of 12 months, during which the children will receive either the treatment or the placebo and have regular check-ups to assess their health and the effectiveness of the treatment.

1 randomization and baseline visit

Upon joining the study, the child will be randomly assigned to one of three groups: two groups receiving different treatment regimens of OM-85 (Broncho Vaxom) and one group receiving a placebo.

The baseline visit will include assessments to confirm eligibility and gather initial health data.

2 treatment period

The treatment period lasts for 12 months. During this time, the child will take the assigned medication orally in the form of a hard capsule.

The medication, OM-85 or placebo, is administered according to the study protocol, which specifies the dosage and frequency.

3 monitoring and follow-up visits

Regular follow-up visits will be scheduled to monitor the child’s health and response to the treatment.

These visits will include assessments to track the number of respiratory tract infections (RTIs) and wheezing lower respiratory illnesses (wLRIs) experienced by the child.

4 end of treatment evaluation

At the end of the 12-month treatment period, a final evaluation will be conducted to assess the overall efficacy of the treatment.

The primary focus will be on the rate of RTIs and wLRIs experienced during the study.

Who Can Join the Study?

Children must be between 6 months and 5 years old. In Italy, children must be between 1 year and 5 years old.
For children 1 year or older, they must have had at least 4 Respiratory Tract Infections (RTIs), which are infections in the parts of the body involved in breathing, including at least 2 episodes of Wheezing Lower Respiratory Illnesses (wLRIs), which are illnesses that cause a whistling sound when breathing, in the past 12 months. At least one of these episodes must have required a hospital visit or a doctor’s appointment.
For children younger than 1 year, they must have had at least 2 RTIs, including at least 1 episode of wLRIs, in the past 6 months. At least one of these episodes must have required a hospital visit or a doctor’s appointment.
Parents or legal representatives must provide written consent, which means they agree in writing for their child to participate in the study.

Who Cannot Join the Study?

Children who are not between 6 months and 5 years old cannot participate.
Children who do not have repeated episodes of respiratory tract infections (infections in the parts of the body used for breathing) with wheezing lower respiratory illness (a condition where there is a whistling sound while breathing due to illness in the lower part of the breathing system) cannot participate.
Children who have any other medical conditions that might interfere with the study cannot participate.
Children who are taking medications that might affect the study results cannot participate.
Children who have participated in another clinical trial recently cannot participate.
Children who have a known allergy to the study medication cannot participate.
Children whose parents or guardians do not agree to follow the study procedures cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Alergo Med Osrodek Badan Klinicznych Sp. z o.o.	Tarnow	Poland

Other Sites

Site Name	City	Country
St. Josef-Hospital	Bochum	Germany
Promed P.Lach R.Glowacki Sp. j.	Cracow	Poland
Aranyklinika Kft.	Szeged	Hungary
Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Rybarczyk I Partnerzy Spolka Lekarska sp.p.	Siemianowice Slaskie	Poland
Centrum Alergologii Sp. z o.o.	Lublin	Poland
Malopolskie Centrum Alergologii Sp. z o.o.	Cracow	Poland
Balassagyarmati Dr. Kenessey Albert Korhaz Rendelointezet	Balassagyarmat	Hungary
Evangelisches Krankenhaus Duesseldorf	Duesseldorf	Germany
Marien-Hospital Wesel gGmbH	Wesel	Germany
Clinmedica Research sp. z o.o.	Skierniewice	Poland
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Semmelweis University	Budapest	Hungary
Universita’ Di Pisa	Pisa	Italy
Ludwig Maximilian University Of Munich	Munich	Germany
Pratia S.A.	Skorzewo	Poland
Heim Pal Orszagos Gyermekgyogyaszati Intezet	Budapest	Hungary
Przychodnia Specjalistyczna Prosen-Med NZOZ	Warsaw	Poland
Cxukhmbu Rpskpexj &eunt Hbrzqxixox Gtno	Schoenau A. Koenigssee	Germany
Amxgcma Osrpbqeonnf Uorzxpatcutwe Pperf	Parma	Italy
Wazafnbgnug Wcmvoaoqqpowaidewoxy Ckykvyq Oeknxhhhv I Twyhdscireegx Ia Mzoftmvptpn W Lmzhb	Lodz	Poland
Frhigasnyl Kecq	Miskolc	Hungary
Sliqvji Dnwrlgarxjupf éy Rbsjtoyxwxuqhm Kapshrr	Gyula	Hungary
Nqip Efkvkc	Bialystok	Poland
Uyjtexkpog Hxaxkzmi Cjavvgv	Cologne	Germany
Pjitjt fqj Kzdyne urd Jfdstkkxllk	Moenchengladbach	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	12.12.2022
Hungary	Not recruiting	12.12.2022
Italy	Not recruiting	12.12.2022
Poland	Not recruiting	12.12.2022

Trial locations

OM-85 (Broncho Vaxom) is a medication used in this clinical trial to help prevent respiratory tract infections in young children. It is designed to boost the immune system and reduce the frequency of infections in children who have recurrent respiratory issues. The study aims to evaluate how effective OM-85 is when used for both short-term and long-term treatment in children aged between 6 months and 5 years who experience wheezing and lower respiratory illnesses.

Respiratory Tract Infections with Wheezing Lower Respiratory Illness – This condition involves infections in the respiratory tract, which can lead to symptoms such as coughing, sneezing, and difficulty breathing. The presence of wheezing indicates that the lower part of the respiratory system, such as the bronchi or lungs, is affected. These infections can be caused by various viruses or bacteria and are more common in young children. The illness often begins with mild symptoms like a runny nose or sore throat and can progress to more severe symptoms, including wheezing and shortness of breath. The frequency and severity of these infections can vary, and they may recur over time, especially in children with a history of respiratory issues.

Trial ID:

2024-511581-37-00

Protocol code:

BV-2020/08

NCT ID:

NCT05677763

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on OM-85 for Preventing Respiratory Infections in Children with Wheezing Illness (Ages 6 Months to 5 Years)

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