EED INTERVENTIONS: PRE- AND PRO-BIOTIC SAFETY Produced by: - - PowerPoint PPT Presentation
6/6/2016 EED INTERVENTIONS: PRE- AND PRO-BIOTIC SAFETY Produced by: Dietrich, C.; Kidane, L.; Babigumira, J. EED Interventions | Agenda Agenda Timeline Project Background and Objectives Key Takeaways Approach & Rationale
EED Interventions
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6/6/2016
EED Interventions
| ¨ Timeline ¨ Project Background and Objectives ¨ Key Takeaways ¨ Approach & Rationale ¨ Methods ¨ Results ¨ Discussion and Next Steps
Agenda
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EED Interventions
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Timeline
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EED Interventions
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Project Background and Objectives
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¨ Very few studies conducted in LMICs ¨ Bifidobacteria and Lactobacillus are the most common genus of
¨ Majority of studies demonstrated no differences in SAEs, adverse
¤ If there were differences, typically pre- and pro-biotics had positive
¨ Difficult to detect significant growth changes in healthy children
Takeaways
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EED Interventions
| ¨ Focus on the inclusion of a stunting measures such
¨ Probiotic or prebiotic as an intervention, no
¨ Expanded to populations beyond LMICs ¨ Analyze safety and efficacy of probiotics in
¤ Adverse events ¤ Infection
Approach & Rationale
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¨ Database: Embase ¨ 'phase 1 trial'/exp OR 'phase 1 trial' OR 'safety' OR 'safety'/exp OR safety
¨ 403 hits
Methods
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| ¨ Prospective studies investigating
¨ Human Subjects ¨ Children <18 ¨ Safety and efficacy trials
¤ Key words: tolerability, safety,
¤ Bactermia or microbiome related
¨ Prioritized: Growth
¨ Retrospective studies, editorials
¨ Animal models/in vitro studies ¨ Adults, including provision to
¨ Combination interventions
¤ E.g. Abx+probiotics
¨ Oral health, potentially non-
¨ No indication of safety other
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Methods
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Methods
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Results
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Results
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Results
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Results
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Results
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Results
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Results
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Results
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Results
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Results
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| ¨ Hosni et al, 2012
¤ Extremely low-birth-weight infants ¤ Enteral feeding ¤ LGG - 500 million CFU + Bifidobacterium infan:s - 500 million CFU ¤ Growth velocity: 14.9 ± 6.5 g/day vs. 12.6 ± 4.5 g/day (p=0.05)
¨ Hays et al, 2015
¤ LBW infants (GA between 25 and 31 weeks, birthweight: 700-1600 g) ¤ Bifidobacterium lac:c; Bifidobacterium longum; or combina<on ¤ No significant differences in LAZ, WAZ, weight gain or head circumference in
Results
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EED Interventions
| ¨ Non-significant differences across the majority
¨ Firmansyah et al, 2011
¤ Change in WAZ – ITT (12 to 16 months) ¤ Syn: 0.11 ± 0.40 vs. Ctl: 0.02 ± 0.40
¨ Gil-campos et al, 2011
¤ LAZ: p=0.021; Syn higher than Ctl w/ Pre (curves shown in Fig. 3) ¤ Length gain (cm/day): Syn higher than Ctl w/ Pre p = 0.038
Results
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Results
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Results
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Timeline
6/6/2016
= Check-In Point
and scope
approach
extract data