L. plantarum ATCC 202195 plus FOS,
does it really help with Reduced sepsis or death by 60 days in healthy, relatively mature rural newborns?
research showsThe grade is C with 56 points. A double-blind placebo-controlled trial across 149 villages in Odisha, India followed 4,556 newborns who weighed at least 2,000 g, were at least 35 weeks' gestation, and had no morbidity at enrollment. Sepsis or death occurred in about 5.4% versus 9.0%, RR 0.60 (95% CI 0.48–0.74), an absolute reduction of about 3.6 points. The calculated NNT is about 28, but the source table reports 27 (19–47), which takes precedence. The trial stopped at 4,556 of a planned 8,442 infants after reaching its prespecified O'Brien–Fleming efficacy boundary. Evidence applies only to the exact patented ATCC 202195 strain plus 150 mg FOS combination.
ads claimThis cannot be compressed into 'probiotics prevent neonatal sepsis.' The strain number, FOS combination, dosing, birth weight, gestational age, health status, and rural context must match.
Useful facts when choosing a product
- The decisive intervention was L. plantarum ATCC 202195 plus FOS.
- Evidence that Korean retail infant products display this strain number was not identified.
- Deaths alone were six versus four, and benefit was driven mainly by less sepsis.
Chamgap Semantic Classification Code
Candidate index · review held
UNK.exact-synbiotic-combination-of-lactiplantibacillus-plantarum-atcc-202195-plus-fructooligosaccharide.UNK.sepsis-or-death-by-in-healthy-relatively-mature-rural-newborns.reduce.placeboUnknown > exact synbiotic combination of Lactiplantibacillus plantarum ATCC 202195 plus fructooligosaccharide > Unknown > sepsis or death by in healthy, relatively mature rural newborns > Reduction claim > Placebo
An automated migration candidate, not an issued permanent code; exact claim scope remains under review. This machine-generated migration candidate helps retrieval but is not a permanent assignment. The original verdict ID and URL remain authoritative.
What the research actually shows
The study was funded by Eunice Kennedy Shriver NICHD grants U01 HD 40574 and R01 HD 53719, with no NICHD role in design, collection, analysis, interpretation, or writing. Individual randomization, double masking, assigned-group analysis of 4,556 infants, and the prespecified composite primary outcome are documented, but the concrete implementation of allocation concealment is not reported. The DSMB unblinded data after 4,556 of the planned 8,442 infants had enrolled; consensus that the prespecified O'Brien–Fleming efficacy boundary had been reached led to early termination.
Why this is classified as C (56)
The prespecified hard composite improved by about 3.6 points, but unreported allocation-concealment implementation and early stopping at 4,556 of a planned 8,442 are two limitations, making B2 and capping the grade at C with 56 points.
Counterpoint. The effect is strain- and combination-specific and is not evidence for critically ill or extremely preterm infants.
Rejudgment record. Cross-check applied — The NIH-funded trial reduced its prespecified hard composite by about 3.6 points, but allocation-concealment implementation was not reported and the trial stopped at 4,556 of a planned 8,442 after reaching its prespecified O'Brien–Fleming efficacy boundary
| Endpoint | H | Hard endpoint - actual events such as death |
| Replication | R1 | Single confirmatory trial |
| Independence | I2 | Decisive evidence is publicly or non-profit funded |
| Effect size | E+ | Meets the clinically important threshold |
Stored derived and displayed grades match; this is not a current recalculation or validity check (C).
Sub-claim grades by effect
This ingredient is marketed for several effects. A single overall grade blends strong and weak claims together, so each effect is graded separately here. The overall grade reflects the strongest disconfirming or core claim.
| Effect (sub-claim) | Grade | Basis |
|---|---|---|
| Reduced sepsis or death with ATCC 202195 plus FOS | C | RR was 0.60 with an absolute reduction of about 3.6 points, but concealment implementation was unreported and the trial stopped early. |
| The same effect from generic infant probiotics | ? | Different strains and combinations are not direct evidence. |
Cross-check — AI research and Codex final gate
Evidence Table
| Study | Design | Sample | Funding | Endpoint | Result | Weight |
|---|---|---|---|---|---|---|
| Panigrahi P et al. 2017 Odisha synbiotic trial | Double-blind placebo-controlled randomized trial across 149 villages; stopped early at a prespecified efficacy boundary | Planned 8,442; 4,556 randomized and analyzed through 60 days | Eunice Kennedy Shriver NICHD, NIH grants U01 HD 40574 and R01 HD 53719; the institute had no research role | Composite of sepsis or death by 60 days | About 5.4% versus 9.0%, RR 0.60 (95% CI 0.48–0.74), absolute difference about -3.6 points, source-table NNT 27 (19–47) versus calculated NNT about 28; deaths 6 versus 4 | Single large publicly funded trial of the exact strain-plus-FOS combination; allocation-concealment implementation unreported and stopped early |
Receipt — 1 References
All 1 cited sources were verified for existence at the original page (as of 2026-08-18).
Final verification and publication gate: Codex · Evidence date: 2026-08-18 · Corrections: none
Cite this verdict
[Chamgap] L. plantarum ATCC 202195 plus FOS x sepsis or death in rural newborns — Evidence Grade C·56. 1 cited sources checked. Source: https://chamgap.com/en/verdicts/immunity/lp-atcc-202195-fos-rural-newborn-sepsis/ · CC BY 4.0CC BY 4.0 — free to use with attribution; do not distort grades, numbers, or verdict meaning.
What this document does and does not do
Chamgap is an information source. It reports what research has and has not confirmed; it does not tell readers what to take or buy. That decision belongs to readers and, when needed, medical or legal professionals. This verdict reflects literature available up to the search date and may change as new research appears. Nothing here is medical advice.