Evidence map›Paper›PMID 41220250›Full record

Observational studyJournal of pediatric gastroenterology and nutrition2026

Fecal calprotectin and other biomarkers are not prospectively associated with food protein-induced allergic proctocolitis.

Timothy Sun, Yamini V Virkud, Mary Kirpas, Kate Gregory, Jocelyn De Paz, Isabel O'Connell, Moran Yassour, Wayne Shreffler, Qian Yuan, Victoria Martin

Abstract readObservational Study
In one paragraph

Observational study in Journal of pediatric gastroenterology and nutrition, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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.

Timothy SunPediatric Allergy Immunology, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA.ORCID https://orcid.org/0009-0001-0345-5700
Yamini V VirkudPediatric Allergy Immunology, University of North Carolina, Chapel Hill, North Carolina, USA.
Mary KirpasPediatric Allergy Immunology, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA.
Kate GregoryPediatric Allergy Immunology, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA.
Jocelyn De PazPediatric Allergy Immunology, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA.
Isabel O'ConnellPediatric Allergy Immunology, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA.
Moran YassourMicrobiology & Molecular Genetics Department, Faculty of Medicine, The Hebrew University of Jerusalem, Jerusalem, Israel.
Wayne ShrefflerPediatric Allergy Immunology, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA.
Qian YuanPediatric Gastroenterology, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA.
Victoria MartinPediatric Gastroenterology, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA.

Funding

Systems approach to elucidate the microbiome's influence on the development of food allergies early in lifeK23AI151556 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI MARTIN, VICTORIA MACKENZIE · 2021 to 2025
$998k
NIAID NIH HHS K23 AI151556NIH NIAID K23AI151556, K23AI130408None
6 · The paper itself

Abstract

objectivesDiagnosis of food protein-induced allergic proctocolitis (FPIAP) is challenging due to the lack of noninvasive biomarkers. We evaluated fecal calprotectin, eosinophil-derived neurotoxin (EDN), and zonulin as potential biomarkers for diagnosing FPIAP, while also examining normal ranges in healthy infants under 12 months.

methodsWe analyzed 214 stool samples from 115 infants (63 with clinically diagnosed FPIAP) over the first year of life from a large prospective observational cohort. We examined the range for each biomarker in infants over time and compared biomarker concentrations in infants with and without FPIAP using linear mixed-effects modeling. We also compared biomarker concentrations to existing 16S rRNA microbiome profiles using MaAsLin2.

resultsConcentrations of calprotectin, EDN, and zonulin were not associated with FPIAP at the time of diagnosis (p = 0.81, p = 0.74, p = 0.24, nor longitudinally (p = 0.356, p = 0.0791, p = 0.333). Calprotectin was found to decrease significantly over the first 12 months of life for both groups (p < 0.001), while EDN and zonulin did not significantly change (p = 0.903, p = 0.043). There was no associated dysbiosis or microbial signature with any of the three biomarkers.

conclusionConcentrations of calprotectin, EDN, and zonulin were not associated with clinically diagnosed FPIAP in our cohort. Very high levels of calprotectin are noted in early infancy in asymptomatic healthy infants, and we provide normal ranges across the first year of life for all three biomarkers. This study does not support the use of fecal calprotectin, EDN, or zonulin for diagnosis of FPIAP.

Indexed as

Dietary ProteinsFecesFood HypersensitivityLeukocyte L1 Antigen ComplexProctocolitisBiomarkersCholera ToxinEosinophil-Derived NeurotoxinFemaleGastrointestinal MicrobiomeHaptoglobinsHumansInfantMaleProspective StudiesProtein PrecursorsBiomarkersCholera ToxinDietary ProteinsEosinophil-Derived NeurotoxinHaptoglobinsLeukocyte L1 Antigen ComplexProtein Precursorszonulin16S rRNA microbiomeeosinophil‐derived neurotoxinreference rangesZonulin

Identifiers

PMID41220250
PMCPMC13044856

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Registered trials

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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.