Full Text View
Tabular View
No Study Results Posted
Related Studies
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.
Verified by University of Turku, June 2008
First Received: September 11, 2005   Last Updated: June 9, 2008   History of Changes
Sponsors and Collaborators: University of Turku
Academy of Finland
Information provided by: University of Turku
ClinicalTrials.gov Identifier: NCT00167700
  Purpose

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.


Condition Intervention
Atopic Eczema
Rhinitis
Asthma
Behavioral: Dietary counselling and products with favourable fat content
Dietary Supplement: Placebo capsules

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Turku:

Primary Outcome Measures:
  • • 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 ]

Secondary Outcome Measures:
  • • 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 ]

Estimated Enrollment: 600
Study Start Date: February 1997
Estimated Study Completion Date: September 2010
Arms Assigned Interventions
1: Experimental
Probiotics + Dietary counseling
Behavioral: Dietary counselling and products with favourable fat content
Counseling to conform with the dietary recommendations. Food products commercially available including spreads and salad dressing. Probiotics
2: Placebo Comparator
Control + placebo
Dietary Supplement: Placebo capsules
Placebo capsules
3: Experimental
Dietary counseling + placebo
Behavioral: Dietary counselling and products with favourable fat content
Counseling to conform with the dietary recommendations. Food products commercially available including spreads and salad dressing. Placebo capsules.

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00167700

Contacts
Contact: Johanna Hvitfelt-Koskelainen, RN +358 2 313 0000 ext 1463 Johanna.Hvitfelt-Koskelainen@tyks.fi

Locations
Finland
Turku University Central Hospital Recruiting
Turku, Finland, 20520
Contact: Erika Isolauri, MD, PhD     +358 2 313 0000 ext 2433     erika.isolauri@utu.fi    
Principal Investigator: Erika Isolauri, MD, PhD            
Principal Investigator: Seppo Salminen, PhD            
Principal Investigator: Kirsi Laitinen, PhD            
Sub-Investigator: Marko Kalliomäki, MD, PhD            
Sub-Investigator: Miguel Gueimonde, PhD            
Sub-Investigator: Tiina Ojala, MD, PhD            
Sub-Investigator: Samuli Rautava, MD, PhD            
Sub-Investigator: Minna-Maija Grönlund, MD, PhD            
Sub-Investigator: Merja Nermes, MD, PhD            
Sub-Investigator: Maria Carmen Collado, PhD            
Sponsors and Collaborators
University of Turku
Academy of Finland
Investigators
Study Director: Erika Isolauri, MD, PhD University of Turku
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: 15214
Study First Received: September 11, 2005
Last Updated: June 9, 2008
ClinicalTrials.gov Identifier: NCT00167700     History of Changes
Health Authority: Finland: Ministry of Social Affairs and Health

Keywords provided by University of Turku:
atopic disease
probiotics
gut microbiota
allergy
nutrition
growth
allergic rhinitis
atopic sensitization
risk-markers of life-style related diseases

Study placed in the following topic categories:
Otorhinolaryngologic Diseases
Dermatitis, Atopic
Skin Diseases
Asthma
Rhinitis
Eczema
Hypersensitivity
Genetic Diseases, Inborn
Respiratory Tract Diseases
Respiratory Tract Infections
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:
Otorhinolaryngologic Diseases
Dermatitis, Atopic
Skin Diseases
Immune System Diseases
Rhinitis
Nose Diseases
Hypersensitivity
Genetic Diseases, Inborn
Respiratory Tract Diseases
Respiratory Tract Infections
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

ClinicalTrials.gov processed this record on July 02, 2009