Oral Bacterial Extract for Wheezing

(ORBEX Trial)

Not currently recruiting at 12 trial locations

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Arizona

Must not be taking: Corticosteroids, Immunotherapy, Immunosuppressants, others

Disqualifiers: Asthma, Seizures, Cardiac disorder, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an oral treatment called Broncho-Vaxom (an oral bacterial extract) can delay the first episode of wheezing in young children. It targets infants at higher risk for wheezing illnesses, particularly those with a family history of asthma or certain skin conditions like atopic dermatitis (a type of eczema). Participants take the treatment for 10 days each month over two years. Suitable candidates for this trial are children under 18 months with a family history of asthma or atopic dermatitis, but without a current asthma diagnosis or serious health conditions. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken inhaled or systemic corticosteroids for respiratory illness in the month before joining. It's best to discuss your current medications with the study team.

Is there any evidence suggesting that Broncho-Vaxom is likely to be safe for humans?

Research has shown that Broncho-Vaxom, also known as OM-85, is generally safe. Studies have found it to be well-tolerated in children and effective in preventing frequent respiratory infections. In one study, children did not experience serious side effects, indicating its safety for them.

Another study found that Broncho-Vaxom effectively treats sudden respiratory infections and prevents recurrence, supporting its strong safety record. Notably, Broncho-Vaxom is already used in other countries to boost the immune system, suggesting it is considered safe there.

Overall, while no treatment is perfect, evidence suggests that Broncho-Vaxom is generally safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for wheezing, which often involves bronchodilators and steroids, Broncho-Vaxom is unique because it harnesses the power of bacterial lysates to potentially boost the immune system. This approach is different because it targets the underlying immune response rather than just alleviating symptoms. Researchers are excited about Broncho-Vaxom as it could offer a preventive strategy, reducing the frequency and severity of wheezing episodes by priming the immune system to respond more effectively to respiratory pathogens.

What evidence suggests that Broncho-Vaxom might be an effective treatment for wheezing?

Research has shown that Broncho-Vaxom, an oral medication, can help prevent breathing problems in children. In this trial, participants will receive either Broncho-Vaxom or a placebo. Studies have found that Broncho-Vaxom can reduce the duration of infections, fevers, coughs, and wheezing in children. In some studies, children who took Broncho-Vaxom experienced fewer respiratory infections and required fewer antibiotics than those who did not. Evidence also indicates that it can delay the first moderate breathing flare-up in children. These findings suggest that Broncho-Vaxom might effectively prevent wheezing and other respiratory issues. ^{1 5 6 7 8}

Who Is on the Research Team?

Wayne J Morgan, MD

Principal Investigator

University of Arizona

Dave T Mauger, PhD

Principal Investigator

Penn State University, Data Coordinating Center

Fernando D Martinez, MD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for infants aged 6-18 months at high risk of wheezing illnesses and asthma, due to a family history of asthma, eczema, or sibling with asthma. They must not have had more than two prior WLRI episodes or certain treatments like steroids and immunotherapy. The child's family should be able to communicate in English/Spanish and stay in the study area for 3 years.

Inclusion Criteria

Adequate completion of informed consent process with written documentation. The participant's legally acceptable representative must have provided the appropriate written informed consent.

I have a parent/guardian who can talk to the study team in English or Spanish.

My child's guardian has a working phone.

Exclusion Criteria

Participants may not have been born earlier than 36 weeks of gestation.

I have not been diagnosed with asthma by a doctor.

You should not have experienced any severe lung infections in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Broncho-Vaxom® or placebo for ten days each month for two consecutive years

24 months

Observation

Three-year observation period to monitor the time to occurrence of the first WLRI episode while off study drug

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Broncho-Vaxom

Trial Overview The trial tests if Broncho-Vaxom (BV), given monthly for two years to high-risk infants, can delay the first episode of wheezing lower respiratory tract illness over three years without treatment. Infants will either receive BV or a placebo.

How Is the Trial Designed?

Group I: Broncho-Vaxom (BV) Active Control 1 Intervention

One capsule of Broncho-Vaxom for children contains: 3.5 mg of lyophilized bacterial lysates of Haemophilus influenzae, Streptococcus (pneumonia, pyogenes and sanguinis (viridans)), Klebsiella (pneumoniae and ozaenae), Staphylococcus aureus and Moraxella catarrhalis. The content of the capsule will be mixed with a palatable liquid such as fruit juice.

Group II: Placebo Placebo Group 1 Intervention

A placebo capsule will be used that will be indistinguishable from the active study drug.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02148796

NCT02148796 | Oral Bacterial Extract for the Prevention of ... The primary objective of this study is to evaluate if Broncho-Vaxom® given to high risk infants for 10 days, monthly, for two consecutive years can increase ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11296687/

A critical analysis of the effect of OM-85 for the prevention of ... Several randomized clinical trials (RCTs) have been performed to determine the efficacy of OM-85 in preventing acute RTIs, acute wheezing episodes, and/or ...

3. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT02148796

Oral Bacterial Extract for the Prevention of Wheezing Lower ... This is a five year parallel arm, double-blind, placebo-controlled trial for the prevention of WLRI into the third to seventh year of life.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1567576917304198

Broncho-Vaxom in pediatric recurrent respiratory tract ... The Broncho-Vaxom group was more effective than control groups in relation to the duration of antibiotics course, infections, fever, cough, and wheezing, ...

5. bmcpulmmed.biomedcentral.com bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-023-02665-4

Effect of Broncho-Vaxom (OM-85) on the frequency of chronic ... BV use was associated with a significantly lower risk of moderate and moderate-to-severe exacerbations, and a delay in the first moderate ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7883224/

Efficacy and safety of OM‐85 in paediatric recurrent ... The impact of OM‐85 consumption on recurrent respiratory tract infections may have a great effect as a tool to improve subjects' immunity.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0149291896800622

Use of Broncho-Vaxom® in private practice: Phase IV trial ... We conclude that Broncho-Vaxom is effective and safe for the treatment of acute episodes of respiratory tract infections and for preventing recurrences.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6438742/

Broncho-Vaxom® (OM-85 BV) soluble components ... Broncho-Vaxom® (OM-85 BV) is an extract of infectious respiratory bacteria that is used as an immunostimulant outside of the United States for the prevention ...