Protocol for the validation of sensitivity and specificity of the Cow's Milk-related Symptom Score (CoMiSS) against open food challenge in a single-blinded, prospective, multicentre trial in infants

Fecha de publicación: 01/05/2018

Autores de IIS La Fe

Carmen Ribes Koninckx

Autor

Participantes ajenos a IIS La Fe

Vandenplas, Y
Mukherjee, R
Dupont, C
Eigenmann, P
Host, A
Kuitunen, M
Shah, N
Szajewska, H
von Berg, A
Heine, RG
Zhao, ZY
Chinese CoMiSS Investigator Team

Grupos

Enfermedad celíaca e Inmunopatología digestiva

Leader

Carmen Ribes Koninckx

Abstract

Introduction The symptoms of cow's milk protein allergy (CMPA) in infancy can be non-specific which may delay a correct diagnosis and cause adverse clinical outcomes. The diagnosis of non-IgE-mediated CMPA is particularly complex as it involves a 2 to 4 week elimination diet followed by oral food challenge (OFC). The Cow's Milk-related Symptom Score (CoMiSS) is a clinical resource for primary healthcare providers which aims to increase awareness of CMPA symptoms to facilitate an earlier diagnosis. The aim of the present study is to assess if the CoMiSS can be used as a potential diagnostic tool in infants with suspected CMPA. Methods and analysis Exclusively formula-fed infants aged 0-6 months presenting with symptoms suggestive of CMPA will be included in this prospective, multicentre trial which will be conducted in 10 centres in China. All infants will commence a 2-week trial of an amino acid-based formula (AAF) while eliminating all cow milk protein from their diets. After the AAF treatment period, infants will undergo an open OFC in hospital with standard cow's milk formula, followed by an open home challenge for another 2 weeks. Clinical symptoms will be documented on standardised symptom scorecards. The CoMiSS will be determined at study entry (CoMiSS 1, before the start of the AAF), after 2 weeks (CoMiSS 2, before the OFC) and after a further period of 2 weeks or when symptoms suggestive of CMPA reappear (CoMiSS 3). Weight and length will be measured at each visit. The difference between CoMiSS 1 and 2 as a predictor of the OFC outcome will also be assessed. The diagnostic accuracy of the baseline CoMiSS will be calculated. Ethics and dissemination The study was approved by the Hunan Children's Hospital Medical Ethics Committee, Hunan, China. The findings of this trial will be submitted for publication in a peer-reviewed journal in paediatric nutrition or gastroenterology. Abstracts will be submitted to the relevant national and international conferences.

Datos de la publicación

ISSN/ISSNe:: 2044-6055, 2044-6055
Tipo:: Article
Páginas:: -
DOI:: 10.1136/bmjopen-2017-019968
Factor de Impacto:: 1,321 SCImago ℠
Cuartil:: Q1 SCImago ℠

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Métricas

Filiaciones

Vandenplas, Y:: Vrije Univ Brussel, UZ Brussel, KidZ Hlth Castle, Brussels, Belgium
Mukherjee, R:: Cytel Software Corp, Cambridge, MA USA
Dupont, C:: Univ Paris 05, Hop Necker Enfants Malad, Paris, France

Grp Hop Inst Catholique Lille, Hop St Vincent de Paul, Clin Pediat St Antoine, Lille, France
Eigenmann, P:: Univ Hosp Geneva, Paediat Allergy Unit, Geneva, Switzerland
Host, A:: Odense Univ Hosp, Hans Christian Andersen Childrens Hosp, Dept Paediat, Odense, Denmark
Kuitunen, M:: Univ Helsinki, Childrens Hosp, Helsinki, Finland

Univ Helsinki, Cent Hosp, Helsinki, Finland
Ribes-Koninkx, C:: La Fe Univ Hosp, Paediat Gastroenterol & Hepatol Unit, Valencia, Spain
Shah, N:: Great Ormond St Hosp Sick Children, London, England

Katholieke Univ Leuven, Leuven, Belgium
Szajewska, H:: Med Univ Warsaw, Dept Paediat, Warsaw, Poland
von Berg, A:: Marien Hosp, Res Inst, Dept Paediat, Wezel, Germany
Heine, RG:: Nestle Hlth Sci, Vevey, Switzerland
Zhao, ZY:: Univ Sch Med, Childrens Hosp Zhejiang, Hangzhou, Zhejiang, Peoples R China