Synbiotic supplementation in critically ill septic children: randomized controlled trial protocol
This document is a study protocol — no efficacy data have been collected or analyzed; the direction of effect is unknown and insufficient for any clinical conclusion.
| Population | Critically ill children with sepsis admitted to PICU (planned n=54) |
|---|---|
| Intervention | Synbiotic KidiLact (10 probiotic strains + fructooligosaccharides), 2 sachets/day for 7 days, oral or via gavage |
| Comparator | Placebo (composition not specified in available text) |
| Outcome | Interleukin-6 (IL-6); Tumor necrosis factor alpha (TNF-α); C-reactive protein (CRP); Erythrocyte sedimentation rate (ESR); Composite clinical outcomes (mortality, PICU length of stay) |
Summary of findings
| Outcome | Effect | 95% CI | Certainty | Clinical relevance | Notes |
|---|---|---|---|---|---|
| Interleukin-6 (IL-6) | not reported (protocol only) | — | Very low | — | |
| Tumor necrosis factor alpha (TNF-α) | not reported (protocol only) | — | Very low | — | |
| C-reactive protein (CRP) | not reported (protocol only) | — | Very low | — | |
| Erythrocyte sedimentation rate (ESR) | not reported (protocol only) | — | Very low | — | |
| Composite clinical outcomes (mortality, PICU length of stay) | not reported (protocol only) | — | Very low | — |
Context
Pediatric sepsis is a leading cause of PICU mortality, with 10–15% prevalence in Iranian PICUs. Gut microbiota modulation via synbiotics is mechanistically plausible but lacks robust confirmatory evidence in critically ill children. Published protocols serve methodological pre-registration purposes, not reporting of results.
What the study showed
The study reports no results — this is a protocol published before trial execution. No efficacy, safety, or effect size data are available. Any benefit projections in the protocol text are speculative and based on prior literature, not on data from this trial.
How it was done
Planned parallel double-blind RCT, n=54 pediatric sepsis patients, 7-day intervention duration, conducted in a PICU in Iran. Randomization and sample size calculation described in protocol; SPSS 19 planned for analysis with p<0.05 significance threshold.
Effect magnitude
No effect size available — study has not been executed or results not published as of this protocol date. 95% CI not applicable.
Risk of bias
As a protocol, RoB 2 cannot be applied to outcome data. Anticipated methodological risks include: small sample (n=54) with questionable statistical power for multiple outcomes; only 7-day intervention, potentially insufficient for sustained microbiota modulation; placebo composition not detailed; exclusively Iranian population limits generalizability; SPSS 19 is outdated; absence of robust primary clinical outcomes such as mortality or ICU length of stay as declared primary endpoints.
What this study does NOT prove
This study proves neither efficacy, safety, nor absence of effect of synbiotic supplementation in pediatric sepsis — it is exclusively a protocol. It establishes neither causality nor generalizability beyond the Iranian context.
In clinical practice
This protocol provides no basis for changes in clinical practice. Clinicians should not adopt synbiotics for pediatric sepsis based on this document alone. Await publication of primary trial results.
Limitations
As a protocol, RoB 2 cannot be applied to outcome data. Anticipated methodological risks include: small sample (n=54) with questionable statistical power for multiple outcomes; only 7-day intervention, potentially insufficient for sustained microbiota modulation; placebo composition not detailed; exclusively Iranian population limits generalizability; SPSS 19 is outdated; absence of robust primary clinical outcomes such as mortality or ICU length of stay as declared primary endpoints.
What is still missing
Publication of trial results with primary data on IL-6, TNF-α, CRP, and ESR, plus clinical outcomes such as 28-day mortality and PICU length of stay.
Technical appendix
Version history
- 1.0 · 2026-06-22 — Auto-generated under Evidence Standard v1.0