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HERDIN Record #: PCHRDPC990196 Submitted: 16 May 2007 Modified: 01 July 2020

The use of lyophilized bacterial lysate (OM-85 BV) in the prevention of recurrent respiratory tract infections in children with left-to-right shunts and those without.

Juliet J. Balderas,
Mayonelo R. Yanilla,
Ma. Chona T. Capulong,
Wilberto L. Lopez

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BACKGROUND: Recurrent respiratory tract infections among children with cardiac left-to-right shunts compared to those without occur because of an increased pulmonary to systematic flow ratio and/or concomitant pulmonary hypertension. One probability for this risk in developing recurrent infections is an acquired immunodeficiency state.

OBJECTIVE: To determine the effect of oral immunotherapy using Lyophilized Bacterial Lysate (OM-85 BV) in children with congenital left-to-right cardiac shunts by measuring their serum IgG, IgM and IgA levels before and after administration and compare them with children without shunt lesions. We wanted further to compare the frequency of respiratory tract infection and the need for antibiotics between the two study groups.

MATERIALS AND METHODS: This is a double-blind prospective study involving 30 children with congenital left-to-right cardiac shunts in Group I (ages 9 months to 7 years) consulting at a tertiary subspecialty hospital for respiratory tract infection. Control population (Group II) were those without left-to-right shunts involving 24 children age-matched with those with shunt, and consulting at a general pediatrics outpatients clinic for respiratory tract infection. Subjects in both population were randomly assigned to placebo and study groups. Both study groups were given 3.5 mg Lyophilized Bacterial Lysate (OM-85 BV) for 10 days for three consecutive months. A placebo was given to the control groups. Blood samples for immunoglobulin levels were taken at Day 0 and Day 90 (20 days after the last dose).

RESULTS: There was a significant decrease in URI episodes in both study groups and use of antibiotics likewise decrease (p value 0.01) compared with the placedo. The decrease in those without CHD was likewise significant but was not significantly different from the placebo. This was attributed to their being a low risk population for frequent URI. IgM and IgA levels increased in both study groups, but a more significant rise among those without congenital left-to-right shunts (p0.01) may indicate an immunodeficient state among children with left-to-right shunts.

CONCLUSION: Oral administration of lyophilized Bacterial Lysate to high risk children with left-to-right shunts as immunotherapy decreases URI episodes and bacterial pneumonia and probably helps mount an immune response as noted in the increased level of serum IgM and IgA levels. Longer observation period from 6 months to 1 year is recommended in both study groups.

Publication Type
Publication Sub Type
Journal Article, Original
Philippine Journal of Cardiology
Publication Date
October-December 1998
LocationLocation CodeAvailable FormatAvailability
Philippine Council for Health Research and Development Box No. 44 Fulltext Print Format
Philippine Council for Health Research and Development Fulltext pdf (Request Document)
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