Condition category
Skin and Connective Tissue Diseases
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
04/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Dineke Klaassen

ORCID ID

Contact details

Numico Research B.V.
P.O. Box 7005
Wageningen
6700 CA
Netherlands
-
Dineke.Klaassen@numico-research.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of early nutrition in high-risk infants on allergy prevention during the first 12 months of life

Acronym

PATCH

Study hypothesis

It is expected that feeding a new hypoallergenic formula will result in a lower occurrence of Atopic Eczema Dermatitis Syndrome (AEDS) compared to giving a standard formula in infants with a high risk of developing atopic disease.

Ethics approval

Received from local medical ethics committee

Study design

Multicentre randomised double-blind active-controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Atopic disease

Intervention

Nutritional intervention starting between the age of 0 to 28 days after birth with formula feeding until the age of 26 weeks in a double-blind, randomised, parallel manner. The study will also include a group of exclusively breastfed infants.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Cumulative incidence of AEDS. Diagnosis according to modified Hanifin and Rajka criteria and SCORAD index of 10 or higher.

Secondary outcome measures

1. Severity and course of AEDS
2. Gastro-intestinal tract characteristics
3. Faecal microbiota
4. Immunological blood parameters

Overall trial start date

31/01/2006

Overall trial end date

31/07/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Newborn infants
2. High risk classification for atopic disease (at lease one of the parents with documented allergic disease)

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

1200

Participant exclusion criteria

1. Premature delivery
2. Twins
3. Neonatal illnesses
4. Significant congenital abnormalities
5. Intake of cow's milk based formula before randomisation

Recruitment start date

31/01/2006

Recruitment end date

31/07/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Numico Research B.V.
Wageningen
6700 CA
Netherlands

Sponsor information

Organisation

Numico Research BV (Netherlands)

Sponsor details

PO Box 7005
Wageningen
6700 CA
Netherlands

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Numico Research BV (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27111273

Publication citations

Additional files

Editorial Notes

04/05/2016: Publication reference added.