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Amino Acid Feed Children's Study

30 octobre 2017 mis à jour par: Nutricia UK Ltd

An Evaluation of the Tolerance and Acceptability of Neocate Junior an Amino Acid Based Formula for Children

This study of the tolerance and acceptability of an amino acid based feed will assess gastrointestinal (GI) tolerance, product intake and acceptability in relation to taste, smell, texture in 20 patients between 1-10 years currently using or requiring an amino acid based feed for the dietary management of Cows' Milk Allergy and food-allergy-associated conditions, over 4 weeks.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Dietary management of Cows' Milk Allergy (CMA) involves avoiding cow's milk protein in the diet, whilst ensuring that an adequate nutritional intake is achieved with suitable alternative foods or prescribable feeds. A number of studies and clinical insights indicate that CMA is persisting longer than infancy, into later childhood and becoming more complex. If a child has CMA, eliminating the offending allergens whilst maintaining an intake of food that meets their nutritional requirements for growth and development is challenging due to the significant nutritional contribution these foods make to a child's diet, particularly milk and dairy products. This supports the need for alternatives to cow's milk to be available for children >1year of age to help meet their nutritional needs. Aminoacid based feeds are already widely used in clinical practice to meet this need. A new nutritionally complete amino acid based powdered feed for the dietary management of CMA, or other conditions where an amino acid based is recommended, in children aged 1-10yrs old, has been developed.

This study is to support the use of this new amino acid based feed in clinical practice. The study will evaluate the tolerance and acceptability of the amino acid based powdered feed in 20 children aged 1-10yrs of age receiving or requiring an amino acid based feed for the dietary management of CMA and food allergy associated conditions, over 4 weeks. The primary outcome will be gastrointestinal tolerance, with secondary outcomes of compliance, acceptability, nutrient intake and anthropometry.

Type d'étude

Interventionnel

Inscription (Réel)

30

Phase

  • N'est pas applicable

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

1 an à 10 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Male or female
  • Age 1-10 years
  • Currently using or requiring an amino acid based feed
  • Expected to receive at least 30% of their energy intake from the study product
  • Written informed consent from parents / carer

Exclusion Criteria:

  • Parenteral nutrition contributing more than 70% of total energy intake
  • Children with major hepatic or renal dysfunction
  • Participation in other studies within 2 weeks prior to entry of this study
  • Investigator concern around willingness/ability of parent/carer to comply with protocol requirements

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: Amino Acid Feed
An amino acid based multi-nutrient powdered feed
Complément alimentaire: Amino Acid Feed
Each child will receive the amino acid based feed for a period of up to 4 weeks (28 days). The feed prescription will be determined on an individual basis by the Dietitian responsible for the child's nutritional management. The child will take the feed orally or via a pre-existing naso-gastric, gastrostomy or jejunostomy tube.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Gastro intestinal tolerance questionnaire
Délai: 4 weeks
Gastro-intestinal tolerance will be recorded at baseline and on days 1, 2, 3 and 7 of week 1 of the study. During weeks 2 and 3 tolerance will be recorded once at the end of each week on days 14 and 21. During week 4, tolerance will be recorded on days 26, 27 and 28. Tolerance will be recorded using a standardised gastro-intestinal tolerance questionnaire, to be completed by the parents/carer
4 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Compliance with feed prescription (amount prescribed versus consumed)
Délai: 4 weeks
Compliance with feed prescription will be assessed daily throughout the study by recording how much feed was received, to be recorded by the parents/carer. The amount prescribed by the Dietitian will be recorded at the start of the study, and any changes to this prescription also noted
4 weeks
Product acceptability questionnaire
Délai: 4 weeks
Feed acceptability (ease of use) will be assessed at the end of week 4 by questionnaire completed by the parents/carer.
4 weeks
Nutrient intake (energy, protein and micronutrients)
Délai: 4 weeks
Nutrient intake, including the intake of all nutrition provided (including the study product, any parenteral feeding, other enteral tube feeding, foods, drinks etc) will be recorded at baseline and on Day 28 by the Dietitian using 24hour recall, and then in 3 day food diaries at baseline (Days 1, 2 and 3) and Week 4 (Days 26, 27 and 28) by the parent/carer. A dietary analysis program will be used to calculate total dietary intake
4 weeks
Weight (kg)
Délai: 4 weeks
For safety purposes, at baseline and at the end of week 4, body weight (kg) will be measured where possible using standard methods, to the nearest 0.1kg using a weighing scale without heavy clothing. Height will also be measured, wherever possible, using standard measures to the nearest 0.1cm. For children up to 2yrs of age, head circumference will be measured where possible, using standard methods to the nearest 0.1cm
4 weeks
Height (cm)
Délai: 4 weeks
For safety purposes, at baseline and at the end of week 4, body weight (kg) will be measured where possible using standard methods, to the nearest 0.1kg using a weighing scale without heavy clothing. Height will also be measured, wherever possible, using standard measures to the nearest 0.1cm. For children up to 2yrs of age, head circumference will be measured where possible, using standard methods to the nearest 0.1cm
4 weeks
Head circumference (cm)
Délai: 4 weeks
For safety purposes, at baseline and at the end of week 4, body weight (kg) will be measured where possible using standard methods, to the nearest 0.1kg using a weighing scale without heavy clothing. Height will also be measured, wherever possible, using standard measures to the nearest 0.1cm. For children up to 2yrs of age, head circumference will be measured where possible, using standard methods to the nearest 0.1cm
4 weeks
Safety by Adverse Event reporting
Délai: 4 weeks
All adverse events will be recorded, throughout the study.
4 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Nutricia UK Ltd

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 novembre 2015

Achèvement primaire (Réel)

1 octobre 2017

Achèvement de l'étude (Réel)

1 octobre 2017

Dates d'inscription aux études

Première soumission

10 juin 2015

Première soumission répondant aux critères de contrôle qualité

6 octobre 2015

Première publication (Estimation)

7 octobre 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 novembre 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 octobre 2017

Dernière vérification

1 octobre 2017

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NJ002

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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Conditions

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