OP PAD Follow up - Primary prevention of atopic disease with prebiotics and the role of the intestinal microflora – Follow up.

Observational, double-blind, controlled follow up study as an extension of a double-blind controlled and randomised study that investigates the effect of partial hydrolysed formula feeding (IF and FOF) supplemented with a mixture of prebiotics in healthy term born infants during their first year of life (during OP PAD) on the prevalence of atopic diseases at 6 years of life.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON28130

Enrollment

Registered

2012-07-03

Start date

2010-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Risk, to develop atopic diseases.

Interventions

NA (Follow-up study).

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children who have completed the OP PAD study; 2. Written informed consent of both patents; 3. Age < 6.5 years.

Exclusion criteria

Exclusion criteria: Investigator's uncertainty about the willingness or ability of the subjects to comply with the protocol requirements.

Design outcomes

Primary

Measure	Time frame
The primary objective of this study was to investigate the occurrence of allergic diseases (allergic eczema, allergic asthma) until the age of 6 years based on presence of allergic symptoms such as eczema, allergic rhinitis and wheeze in children included in the previous OP PAD study, who were at risk of developing allergic disease, and had received either a partial hydrolysed infant formula supplemented with a prebiotic mixture of scGOS/lcFOS/pAOS or a partial hydrolysed infant formula without prebiotics or who were fully breastfed during the first year of life.	—

Measure

Time frame

The primary objective of this study was to investigate the occurrence of allergic diseases (allergic eczema, allergic asthma) until the age of 6 years based on presence of allergic symptoms such as eczema, allergic rhinitis and wheeze in children included in the previous OP PAD study, who were at risk of developing allergic disease, and had received either a partial hydrolysed infant formula supplemented with a prebiotic mixture of scGOS/lcFOS/pAOS or a partial hydrolysed infant formula without prebiotics or who were fully breastfed during the first year of life.

—

Secondary

Measure	Time frame
Secondary objective of this study is to investigate in the OP PAD study participants at 6 years of age the following: 1. In case of allergic manifestations the severity of atopic dermatitis and allergic asthma; 2. Allergic rhinitis; 3. Lung function measurements; 4. Immunological Parameters; 5. Intestinal flora.	—

Contacts

Public ContactNutricia Research

Nutricia Research - Advanced Medical Nutrition;

barbara.mourmans@nutricia.comTelephone: +31 (0)30 209 5000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)