Evidence map›Paper›PMID 34980887›Full record

Trial reportPediatric research2022

Probiotic supplementation in neonates with congenital gastrointestinal surgical conditions: a pilot randomised controlled trial.

Shripada Rao, Meera Esvaran, Liwei Chen, Anthony D Keil, Ian Gollow, Karen Simmer, Bernd Wemheuer, Patricia Conway, Sanjay Patole

2 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pediatric research, 2022. 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 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
1.7field-weighted citation impact, top 18% 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.

NCT05815433 nacompletednot on this mapstarted 2023, after this paper: background citation

Comparing Impacts of Donor Human Milk to Formula Supplementation on the Gut Microbiome of Full-term Infants Exposed to Antibiotics in Labour: A Pilot Randomized Controlled Trial

TypeinterventionalSponsorUniversity of CalgaryRan2023 to 2025Enrolled105ConditionsMicrobial ColonizationArmsDonor Human Milk - Nutritional Replacement
NCT06177184 narecruitingnot on this mapstarted 2024, after this paper: background citation

DOnor Milk to REpair the Full-term Infant MIcrobiome in Infants Born Via Caesarean Section

TypeinterventionalSponsorUniversity of CalgaryRan2024 to 2027Enrolled90ConditionsMicrobial ColonizationArmsDonor Human Milk - Nutritional Replacement
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Development and Evaluation of a Generative AI Chatbot for Database Searching in Systematic Review.Journal of nursing scholarship : an official publication of Sigma Theta Tau International Honor Society of Nursing · 2026
    Article
  6. Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Impact ofNutrients · 2024
    Review
  12. Review
  13. Review
  14. 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

9 authors at 5 institutions in 3 countries.

Shripada RaoNeonatal Intensive Care Unit, Perth Children's Hospital, Perth, WA, Australia. shripada.rao@health.wa.gov.au.
Meera EsvaranCentre for Marine Science and Innovation at the University of New South Wales (UNSW), Sydney, NSW, Australia.
Liwei ChenSchool of Chemical and Biomedical Engineering, Nanyang Technological University, Singapore, Singapore.
Anthony D KeilDepartment of Microbiology, PathWest Laboratory Medicine, Perth, WA, Australia.
Ian GollowDepartment of Paediatric Surgery, Perth Children's Hospital, Perth, WA, Australia.
Karen SimmerNeonatal Intensive Care Unit, Perth Children's Hospital, Perth, WA, Australia.
Bernd WemheuerCentre for Marine Science and Innovation at the University of New South Wales (UNSW), Sydney, NSW, Australia.
Patricia ConwayCentre for Marine Science and Innovation at the University of New South Wales (UNSW), Sydney, NSW, Australia.
Sanjay PatoleNeonatal Intensive Care Unit, Perth Children's Hospital, Perth, WA, Australia.
Perth Children's HospitalUNSW Sydney · AUNanyang Technological University · SGPathwest Laboratory Medicine · AUUniversity of Western Australia · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate whether probiotic supplementation attenuates gut-dysbiosis in neonates with congenital gastrointestinal surgical conditions (CGISC).

methodsSixty-one neonates (≥35 weeks gestation) with CGISC were randomised to receive daily supplementation with a triple-strain bifidobacterial probiotic (n = 30) or placebo (n = 31) until discharge. Stool microbiota was analysed using 16S ribosomal RNA gene sequencing on samples collected before (T1), 1 week (T2), and 2 weeks (T3) after supplementation and before discharge (T4). The primary outcome was the sum of the relative abundance of potentially pathogenic families of Clostridiaceae, Enterobacteriaceae, Enterococcaceae, Pseudomonaceae, Staphylococcaeae, Streptococcaceae, and Yersiniaceae at T3.

resultsThe median gestational age [38 weeks (IQR: 37.1-38.9)] was similar in both groups. The probiotic group had lower rates of caesarean deliveries (40% versus 70%, p = 0.02). The relative abundance of potentially pathogenic families was lower in the probiotic group compared to placebo at T3 [(median: 50.4 (IQR: 26.6-67.6) versus 67.1 (IQR: 50.9-96.2); p = 0.04). Relative abundance of Bifidobacteriaceae was higher in the probiotic group at T3 [(median: 39.8 (IQR: 24.9-52.1) versus 0.03 (IQR 0.02-2.1); p < 0.001). Stratified analysis continued to show a higher abundance of Bifidobacteriaceae in the probiotic group, irrespective of the mode of delivery.

conclusionsProbiotic supplementation attenuated gut dysbiosis in neonates with CGISC.

trial registrationhttp://www.anzctr.org.au (ACTRN12617001401347). IMPACT: Probiotic supplementation attenuates gut dysbiosis and improves stool short-chain fatty acid levels in neonates with congenital gastrointestinal surgical conditions. This is the second pilot RCT of probiotic supplementation in neonates with congenital gastrointestinal conditions. These findings will pave the way for conducting multicentre RCTs in this area.

Indexed as

Gastrointestinal DiseasesProbioticsBifidobacteriumDysbiosisFatty Acids, VolatileFemaleHumansInfantInfant, NewbornPilot ProjectsPregnancyFatty Acids, Volatile

Identifiers

PMID34980887
PMCPMC8722408
OpenAlexW4205849390

What OpenQuestion holds

Textmetadata
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.