Evidence map›Paper›PMID 29380821›Full record

Trial reportThe American journal of gastroenterology2018

Randomized Double-Blind Placebo-Controlled Crossover Trial for the Diagnosis of Non-Celiac Gluten Sensitivity in Children.

R Francavilla, F Cristofori, L Verzillo, A Gentile, S Castellaneta, C Polloni, V Giorgio, E Verduci, E DʼAngelo, S Dellatte and 1 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The American journal of gastroenterology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02431585 (Prevalence of Gluten Sensitivity in Irritable Bowel Syndrome), which is not on this map. Cited by 23 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 3 pooled it
6.0field-weighted citation impact, top 3% 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.

NCT02431585 naunknown statusnot on this map

Prevalence of Gluten Sensitivity in Irritable Bowel Syndrome: The First Study in Paediatrics. (GS-IBS)

TypeinterventionalSponsorUniversity of BariRan2015 to 2015Enrolled100ConditionsIrritable Bowel Syndrome, Gluten SensitivityArmsgluten, placebo
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 3 syntheses or guidelines pooled it, 67 citations in OpenAlex.

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  2. Pooled it
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  16. An Update on the Assessment and Management of Pediatric Abdominal Pain.Pediatric health, medicine and therapeutics · 2021
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 1 country.

R FrancavillaInterdisciplinary Department of Medicine-Pediatric Section, University of Bari, Bari, Italy.
F CristoforiInterdisciplinary Department of Medicine-Pediatric Section, University of Bari, Bari, Italy.
L VerzilloInterdisciplinary Department of Medicine-Pediatric Section, University of Bari, Bari, Italy.
A GentileInterdisciplinary Department of Medicine-Pediatric Section, University of Bari, Bari, Italy.
S CastellanetaDepartment of Pediatrics, San Paolo Hospital, Bari Italy.
C PolloniDepartment of Pediatrics, Santa Maria del Carmine Hospital, Rovereto TN, Italy.
V GiorgioDepartment of Pediatrics, Catholic University, Rome, Italy.
E VerduciDepartment of Pediatrics, University of Milan, S. Paolo Hospital, Milan, Italy.
E DʼAngeloDepartment of Pediatrics, Santa Maria Incoronata dell'Olmo Hospital.
S DellatteTandoi Group Factory, Corato, Italy.
F IndrioInterdisciplinary Department of Medicine-Pediatric Section, University of Bari, Bari, Italy.
University of Bari Aldo Moro · ITOspedale Pediatrico Giovanni XXIII · ITOspedale San Paolo · ITOspedale San Paolo · ITOspedale Santa Maria · ITSanta Maria Nuova Hospital · ITUniversità Cattolica del Sacro Cuore · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesNon-celiac gluten sensitivity (NCGS) is characterized by intestinal and extra-intestinal symptoms that are related to the ingestion of gluten in subjects who are not affected by either celiac disease (CD) or wheat allergy (WA). In this multicenter study, we aim for the first time to evaluate the prevalence of NCGS in pediatric subjects with chronic functional gastrointestinal symptoms associated with gluten ingestion using a double-blind placebo-controlled (DBPC) gluten challenge with crossover.

methodsAmong 1,114 children with chronic gastrointestinal symptoms (negative CD and WA), those exhibiting a positive correlation between symptoms and gluten ingestion were eligible for a diagnostic challenge including the following phases: run-in, open gluten-free diet (GFD) and DBPC crossover gluten challenge. Patients were randomized to gluten (10 g/daily) and placebo (rice starch) for 2 weeks each, separated by a washout week. The gluten challenge was considered positive in the presence of a minimum 30% decrease of global visual analogue scale between gluten and placebo.

resultsOut of 1,114 children, 96.7% did not exhibit any correlation with gluten ingestion. Thirty-six children were eligible; after the run-in and open GFD, 28 patients entered the gluten challenge. Eleven children (39.2%; 95% CI: 23.6-53.6%) tested positive.

conclusionsThis is the first demonstration of the existence of NCGS in children that reinforce the need for a DBPC for the diagnosis as the diagnosis is ruled out in >60% of cases. The registration identifier in ClinicalsTrials.gov is NCT02431585.

Indexed as

GlutensAdolescentChildCross-Over StudiesDiet, Gluten-FreeDouble-Blind MethodFemaleGastrointestinal DiseasesHumansMaleVisual Analog ScaleGlutens

Identifiers

PMID29380821
OpenAlexW2791231429

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.