Evidence map›Paper›PMID 24840511›Full record

Trial reportJournal of pediatric gastroenterology and nutrition2014

Effects of term infant formulas containing high sn-2 palmitate with and without oligofructose on stool composition, stool characteristics, and bifidogenicity.

Manjiang Yao, Eric L Lien, Maria R Z Capeding, Margaret Fitzgerald, Kalathur Ramanujam, Rebecca Yuhas, Robert Northington, Jowena Lebumfacil, Lin Wang, Patricia A DeRusso

2 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of pediatric gastroenterology and nutrition, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 40 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03331276 nacompletednot on this mapstarted 2017, after this paper: background citation

Growth and Safety Study of an Infant Formula for Healthy Term Infants

TypeinterventionalSponsorBuilding Block Nutritionals, LLCRan2017 to 2019Enrolled260ConditionsInfant DevelopmentArmsBBN, Brand
NCT04593147 nacompletednot on this mapstarted 2020, after this paper: background citation

Phase II Growth and Safety Study of an Infant Formula for Healthy Term Infants

TypeinterventionalSponsorBuilding Block Nutritionals, LLCRan2020 to 2021Enrolled131ConditionsInfant DevelopmentArmsBBN, Brand
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Manjiang Yao*Research and Development, Nestlé Nutrition, King of Prussia, PA †Department of Food Science and Human Nutrition, University of Illinois, Urbana ‡Department of Pediatrics, Asian Hospital and Medical Center, Muntinlupa City, Philippines §Research and Development, Wyeth Nutritionals Ireland, Askeaton ||Medical Affairs Department, Wyeth Philippines Inc, Makati City, Philippines ¶Worldwide Research and Development, Pfizer Inc, Peapack, NJ #Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA.
Eric L Lien
Maria R Z Capeding
Margaret Fitzgerald
Kalathur Ramanujam
Rebecca Yuhas
Robert Northington
Jowena Lebumfacil
Lin Wang
Patricia A DeRusso

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesLevels of stool fatty acid soaps and beneficial bacteria differ between formula-fed and breast-fed infants; addition of specific formula ingredients may reduce these differences. This study evaluated the effects of a term infant formula containing high sn-2 palmitate term infant formula (sn-2) or an identical formula supplemented with oligofructose (OF) at 2 concentrations (sn-2+3 g/L OF, sn-2+5 g/L OF) on stool composition, stool characteristics, and fecal bifidobacteria.

methodsHealthy, term formula-fed infants 7 to 14 days old (n = 300) were randomized in a double-blind manner to receive standard formula (control), sn-2, sn-2+3 g/L OF, or sn-2+5 g/L OF for 8 weeks. Human milk (HM)-fed infants (n = 75) were studied in parallel. Stool samples were collected from all subjects at week 8 for fatty acid soaps and mineral content, and from a subset at baseline and week 8 for bifidobacteria. Stool characteristics were assessed via 3-day diary.

resultsThe sn-2 group had 46% less stool soap palmitate (P < 0.001) and softer stools than control (20% more mushy soft stools, P = 0.026; 50% fewer formed stools, P = 0.003). Addition of OF resulted in even fewer formed stools versus control (65% fewer for sn-2+3 g/L OF, 79% fewer for sn-2+5 g/L OF), with 5 g/L OF more closely resembling that of HM-fed infants. Both sn-2 (P < 0.05) and sn-2 with OF groups (P < 0.01) had significantly higher fecal bifidobacteria concentrations than control at week 8, not differing from HM-fed infants.

conclusionsHigh sn-2-palmitate formulas led to reduced stool soaps, softer stools, and increased bifidobacteria, whereas addition of OF further improved stool consistency. Those modifications brought outcomes in formula-fed infants closer to that in HM-fed infants.

Indexed as

BifidobacteriumDietary SupplementsAdultBreast FeedingConstipationDefecationDouble-Blind MethodFecesFemaleHardnessHumansInfantInfant FoodInfant FormulaInfant, NewbornMaleoligofructoseOligosaccharidesPalmitates

Identifiers

PMID24840511
PMCPMC4222706

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.