Milk-induced Gastrointestinal Symptoms in Infants

NCT01684319 | Completed

• 1 other identifier: 11-202 (MATPED 11-047)
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Various digestive manifestations are common in infants less than 6 months and have a significant impact on morbidity and quality of life of the family. In a prospective study on more than 2800 Italian infants followed by 0-6 months of life, it was determined that 55% of these children had gastrointestinal symptoms such as regurgitation (23%), colics (20%), constipation (17%) or poor weight gain (15%). However, these symptoms are not very accurate, and their cause is often difficult to determine. Frequently, the pediatrician will exclude cow's milk protein in infant feeding, but without a clear etiological diagnosis was asked. This measure causes significant additional costs through the use of extensively hydrolyzed milk specifically for children and involves an elimination diet of all foods containing cow's milk sometimes for several years. This can negatively influence the growth of the child. If the involvement of milk in these pathologies is suggested by some early studies (35% for colics, 68% in constipation, 42% in gastroesophageal reflux), it is unclear in the current state of knowledge if these gastrointestinal symptoms are actually due to an "allergy" to milk. Moreover, there is no validated diagnostic test for non-IgE-mediated gut allergy. However, various tests have proven their effectiveness in the investigation of non IgE-mediated allergy (eg. LAT, patch tests) and will be used in this study.

Conditions

Gastrointestinal Symptoms in Young Infants

Keywords

Constipation; Gastroeosphageal reflux; Colics

Outcome Measures

Primary Outcomes (1)

• Milk allergy in gastrointestinal diseases in young infants

  Establish the role of milk proteins in gastrointestinal diseases in young infants

  10 weeks

Secondary Outcomes (1)

• Diagnostic tests

  10 weeks

Study Arms (2)

Infant formula milk

PLACEBO COMPARATOR

Infant formula milk adapted to age of infant

Dietary Supplement: Placebo

Formula milk free of milk proteins

ACTIVE COMPARATOR

Milk-free formula milk adapted to age of infant

Dietary Supplement: Formula milk free of cow's milk protein

Interventions

Formula milk free of cow's milk protein DIETARY_SUPPLEMENT

Formula milk free of milk proteins

Placebo DIETARY_SUPPLEMENT

Infant formula milk

Infant formula milk

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants 0-6 month old with at least one of the following symptoms : constipation, gastroesophageal reflux, colics

You may not qualify if:

• Prematurity
• exclusive breastfeeding
• Other cause for symptoms

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Département de l'enfant et de l'adolesent - Hôpitaux Universitaires de Genève

Geneva, Canton of Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Constipation; Colic

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Philippe A Eigenmann, MD

  Hôpitaux Unversitaire de Genève

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 10, 2012
• First Posted: September 12, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 6, 2014

Record last verified: 2014-01

Locations

CH (1)