Evidence map›Paper›PMID 39567910›Full record

Trial reportBMC pediatrics2024

Common gastrointestinal symptoms in healthy infants receiving goat milk-based formula or cow's milk-based formula: a double-blind, randomized, controlled trial.

P Maximino, L van Lee, Yvonne N Meijer-Krommenhoek, L van der Zee, H da Costa Ribeiro Junior

Registry-linked trialAbstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in BMC pediatrics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06395571 (Common Gastrointestinal Symptoms in Healthy Infants Receiving Goat Milk-based Formula or Cow Milk-based Formula), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT06395571 nacompletednot on this map

Common Gastrointestinal Symptoms in Healthy Infants Receiving Goat Milk-based Formula or Cow Milk-based Formula: a Double-blind, Randomized Controlled Trial

TypeinterventionalSponsorAusnutria Hyproca B.V.Ran2019 to 2019Enrolled56ConditionsGastrointestinal Diseases, Infant Nutrition DisordersArmsGoat milk-based infant formula, Cow's milk-based infant formula
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. 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

5 authors.

P MaximinoAusnutria B.V, Zwolle, The Netherlands.
L van LeeAusnutria B.V, Zwolle, The Netherlands.
Yvonne N Meijer-KrommenhoekAusnutria B.V, Zwolle, The Netherlands. yvonne.meijer-krommenhoek@ausnutria.nl.
L van der ZeeAusnutria B.V, Zwolle, The Netherlands.
H da Costa Ribeiro JuniorHospital Professor Edgard Santos, Federal University of Bahia, Salvador, Brazil.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess common gastrointestinal symptoms in healthy Brazilian infants receiving goat milk-based formula (GMF) compared to cow's milk-based formula (CMF).

methodsWe performed a 24-weeks double-blind, randomized, controlled study in Brazil, enrolling healthy infants from 3 to 12 months of age. Primary outcome were the gastrointestinal (GI) symptoms stool consistency, regurgitation frequency and crying duration. Secondary outcomes were growth trajectories and hemoglobin levels. Repeated mixed models were used to compare outcomes variables between GMF and CMF groups, while adjusting for age at baseline.

resultsFifty-six infants were recruited and randomly allocated in the GMF (n = 26) and the CMF (n = 30) group. Scores on all measured GI symptoms were low and similar among the groups throughout intervention period and improved over time. Average age- and sex-adjusted WHO z-scores of weight, length, head circumference, and weight-for-length were all within +/-1 SD and similar between groups, indicating adequate growth. Serum hemoglobin was 11.1 (SD 0.7) g/dL in infants fed GMF and 11.0 (SD 0.8) g/dL in infants fed CMF after the intervention and was similar between groups.

conclusionGMF was well tolerated, safe and supported adequate growth in infants. This was shown by the low occurrence of GI symptoms, adequate blood hemoglobin levels and adequate growth within WHO standards.

trial registrationThe clinical trial was approved by the ethics committee of the Federal University of Bahia under number CAAE06923319.5.0000.5577. The study was retrospectively registered in clinicaltrials.gov on 02/05/2024 under identifier NCT06395571.

Indexed as

GoatsInfant FormulaMilkAnimalsBrazilCattleCryingDouble-Blind MethodFemaleGastrointestinal DiseasesHemoglobinsHumansInfantMaleHemoglobinsBreast-milk substitutesGoat milk-based infant formulaInfant formulaInfant Nutrition

Identifiers

PMID39567910
PMCPMC11577781

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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.