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The Effects of Maternal Nutrition During Pregnancy and Breast Feeding on the Risk of Allergic Disease in Child (NAMI)
This study is currently recruiting participants.
Study NCT00167700   Information provided by University of Turku
First Received: September 11, 2005   Last Updated: June 9, 2008   History of Changes

September 11, 2005
June 9, 2008
February 1997
 
• Child: Atopy and atopic diseases (1, 2, 4, 7-8 and 10 years of age) and gut microbiota • Mother: Nutritional and immunological status and weight development during pregnancy, lactation and up to 7 years postpartum [ Time Frame: 6 months ]
Atopic disease (atopic sensitization at 12 months, atopic eczema at 24 months, atopic eczema and asthma at 4 and 7-8 years of age).
Complete list of historical versions of study NCT00167700 on ClinicalTrials.gov Archive Site
  • • Growth and development, nutritional (lipid, glucose, vitamin metabolism) and immunological (cytokines, leukotrienes, adipokines) status, cardiovascular disease risk factors (blood pressure) and intakes of foods and nutrients from infancy to 7 years [ Time Frame: 6 months ]
  • • Maternal dietary intakes of foods and nutrients during pregnancy, lactation and up to 7 years postpartum. [ Time Frame: 6 months ]
  • • Associations between maternal and offspring nutritional and immunological status, and transfer of microbiota, microbiological composition and interaction, and health indicators of child (allergy, cardiovascular disease risk markers, weight development [ Time Frame: 6 months ]
Growth and well-being, nutritional and immunological status in infancy, growth at 4-8 years, intake of foods and nutrients during pregnancy and child's age of 6, 12, 24, 48 and 72 months, lipid metabolism and vitamin status. Cardiovascular risk factors
 
The Effects of Maternal Nutrition During Pregnancy and Breast Feeding on the Risk of Allergic Disease in Child
Nutrition, Allergy, Mucosal Immunology and Intestinal Microbiota (NAMI): Early Nutrition and Later Consequences - The Effects of Maternal Nutrition During Pregnancy and Breast Feeding on the Risk of Allergic Disease in Child

The objective of the project is to accomplish intervention studies to provide a new direction in the search for scientifically validated means of treating and preventing allergic inflammation and atopic diseases at an early age; to explore contributing dietary factors and to identify novel immunomodulatory tools.

Industrialized countries worldwide have been faced with a progressive increase in immune-mediated health problems such as allergic, autoimmune and inflammatory diseases. Atopic eczema, allergic rhinitis and asthma affect approximately 30% of the population, and allergic diseases constitute the most common chronic diseases of childhood. New approaches in the fight against allergic diseases are clearly called for, the target being the persistence of the allergic responder pattern beyond infancy. Such T helper (TH) 2-skewed immune type, universal at an early age, may be balanced by cytokines secreted by TH1, TH3 and Tr1 cells, partially as a result of stimulation by the gut microbiota. The project has demonstrated that specific strains of the healthy gut microbiota (probiotics) may aid in degradation/ structural modification of antigens, normalization of the properties of aberrant indigenous microbiota and of gut barrier functions, regulation of the secretion of inflammatory mediators, and direction of the development of the immune system during the critical period of life when these functions are immature and the risk of allergic disease is heightened. Based on previous demonstrations, a combined program: Nutrition, Allergy, Mucosal immunology and Intestinal microbiota (NAMI)- has been created. The current research interest is directed towards health promotion and reducing the risk of disease evaluating the probiotic effects with specific foods and nutrients, and assessing their interactions in optimal combination and food matrix.

Pregnant women with a positive family history of atopic disease are enrolled. The study is divided into three different sections.

In the first section, probiotics/ placebo has been given to mothers (N=159) 2-4 weeks before term. After delivery probiotics/placebo was administered orally to the infants or consumed by breastfeeding mothers for 6 months. The infants are clinically followed until 10 years of age.

In the second section, the same design is applied to analyze the probiotic mechanisms; pregnant women (n=192) with history of allergy or symptoms of atopic diseases and who intend to breastfeed for at least 2 months are randomized to receive probiotics/placebo before delivery until 2 months after delivery, and the infants will be clinically followed until 2 years of age.

In the third section, women (n=256) from families with at least one family member having an allergic disease have been recruited from maternal welfare clinics and randomly assigned to study groups:

  1. control group, (placebo)
  2. intervention group 1 (diet counseling and placebo) and
  3. intervention group 2 (diet counseling and probiotics), probiotic administered in a double-blind fashion Diet counseling and probiotic supplementation will be continued for the recommended period of exclusive breast feeding. The mothers and their infants will be clinically followed until child's age of 7years.
 
Interventional
Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
  • Atopic Eczema
  • Rhinitis
  • Asthma
  • Behavioral: Dietary counselling and products with favourable fat content
  • Dietary Supplement: Placebo capsules
  • Experimental: Probiotics + Dietary counseling
  • Placebo Comparator: Control + placebo
  • Experimental: Dietary counseling + placebo

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
600
September 2010
 

Inclusion Criteria:

  • Pregnant women from families with at least one family member having an allergic disease

Exclusion Criteria:

  • Women presenting severe immunological or other chronic diseases (rheumatoid arthritis, diabetes, inflammatory bowel disease, thyroid diseases, malignancies etc.)
  • Women who cannot be expected to comply with treatment
  • Women currently participating or having participated in other clinical trial during the last 2 months prior to the beginning of the intervention.
Female
18 Years and older
No
Contact: Johanna Hvitfelt-Koskelainen, RN +358 2 313 0000 ext 1463 Johanna.Hvitfelt-Koskelainen@tyks.fi
Finland
 
NCT00167700
 
15214
University of Turku
Academy of Finland
Study Director: Erika Isolauri, MD, PhD University of Turku
University of Turku
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP