Evidence map›Paper›PMID 35684099›Full record

ArticleNutrients2022

Effects of an Amino Acid-Based Formula Supplemented with Two Human Milk Oligosaccharides on Growth, Tolerability, Safety, and Gut Microbiome in Infants with Cow's Milk Protein Allergy.

Michael S Gold, Patrick J Quinn, Dianne E Campbell, Jane Peake, Joanne Smart, Marnie Robinson, Michael O'Sullivan, Josef Korbinian Vogt, Helle Krogh Pedersen, Xiaoqiu Liu and 2 more

Registry-linked trialOpen access · goldAbstract readMulticenter Study
In one paragraph

Article in Nutrients, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03661736 (Growth of Infants With Cow's Milk Allergy Fed an Amino Acid-based Formula Containing Two Human Milk Oligosaccharides), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
3.5field-weighted citation impact, top 6% of its field
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.

NCT03661736 completednot on this map

Growth of Infants With Cow's Milk Allergy Fed an Amino Acid-based Formula Containing Two Human Milk Oligosaccharides: Comparison With World Health Organization (WHO) Growth Standards in an Observational, Single-arm Study

TypeobservationalSponsorSociété des Produits Nestlé (SPN)Ran2018 to 2020Enrolled33ConditionsCow Milk AllergyArmsFood for Specific Medical Purpose
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Review
  8. Article
  9. Observational
  10. Review
  11. Review
  12. Review
  13. Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Review
  19. Article
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

12 authors at 9 institutions in 3 countries.

Michael S GoldDepartment of Allergy & Immunology, Women's and Children's Hospital, University of Adelaide, Adelaide, SA 5006, Australia.
Patrick J QuinnDepartment of Allergy & Immunology, Women's and Children's Hospital, University of Adelaide, Adelaide, SA 5006, Australia.
Dianne E CampbellDepartment of Allergy & Clinical Immunology, Children's Hospital at Westmead, University of Sydney, Sydney, NSW 2145, Australia.
Jane PeakeQueensland Paediatric Immunology and Allergy Service, Queensland Children's Hospital, University of Queensland, South Brisbane, QLD 4101, Australia.ORCID 0000-0001-9003-5861
Joanne SmartPaediatric Allergy Services, Epworth Hospital, Richmond, VIC 3121, Australia.
Marnie RobinsonMelbourne Allergy Centre & Children's Specialists Medical Group, Parkville, VIC 3152, Australia.
Michael O'SullivanDepartment of Immunology, Perth Children's Hospital, Nedlands, WA 6009, Australia.
Josef Korbinian VogtClinical Microbiomics, DK-2100 Copenhagen, Denmark.
Helle Krogh PedersenClinical Microbiomics, DK-2100 Copenhagen, Denmark.
Xiaoqiu LiuBiostatistics and Data Science Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW 2042, Australia.
Elham Pazirandeh-MicolNestlé Health Science, CH-1800 Vevey, Switzerland.
Ralf G HeineNestlé Health Science, CH-1800 Vevey, Switzerland.ORCID 0000-0002-3343-0379
Clinical Microbiomics (Denmark) · DKNestlé (Switzerland) · CHWomen's and Children's Hospital · AUEpworth Hospital · AUPrincess Margaret Hospital for Children · AURoyal Children's Hospital · AUThe University of Queensland · AUThe University of Sydney · AUUNSW Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This open-label, non-randomized, multicenter trial (Registration: NCT03661736) aimed to assess if an amino acid-based formula (AAF) supplemented with two human milk oligosaccharides (HMO) supports normal growth and is well tolerated in infants with a cow's milk protein allergy (CMPA). Term infants aged 1-8 months with moderate-to-severe CMPA were enrolled. The study formula was an AAF supplemented with 2'-fucosyllactose (2'-FL) and lacto-N-neotetraose (LNnT). Infants were fed the study formula for 4 months and were offered to remain on the formula until 12 months of age. Tolerance and safety were assessed throughout the trial. Out of 32 infants (mean age 18.6 weeks; 20 (62.5%) male), 29 completed the trial. During the 4-month principal study period, the mean weight-for-age Z score (WAZ) increased from -0.31 at the baseline to +0.28 at the 4-months' follow-up. Linear and head growth also progressed along the WHO child growth reference, with a similar small upward trend. The formula was well tolerated and had an excellent safety profile. When comparing the microbiome at the baseline to the subsequent visits, there was a significant on-treatment enrichment in HMO-utilizing bifidobacteria, which was associated with a significant increase in fecal short-chain fatty acids. In addition, we observed a significant reduction in the abundance of fecal Proteobacteria, suggesting that the HMO-supplemented study formula partially corrected the gut microbial dysbiosis in infants with CMPA.

Indexed as

Gastrointestinal MicrobiomeMilk HypersensitivityAmino AcidsAnimalsCattleFemaleHumansInfantInfant FormulaMaleMilk, HumanOligosaccharidesAmino AcidsOligosaccharides2′-fucosyllactosebifidobacteriadysbiosisgut microbiomehypoallergenic formulalacto-N-neotetraosemetagenomic sequencingshort chain fatty acids

Identifiers

PMID35684099
PMCPMC9182596
OpenAlexW4281769486

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.