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| Tracking Information | |||||
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| First Received Date ICMJE | September 11, 2005 | ||||
| Last Updated Date | June 9, 2008 | ||||
| Start Date ICMJE | February 1997 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
• 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 ] | ||||
| Original Primary Outcome Measures ICMJE |
Atopic disease (atopic sensitization at 12 months, atopic eczema at 24 months, atopic eczema and asthma at 4 and 7-8 years of age). | ||||
| Change History | Complete list of historical versions of study NCT00167700 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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 | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effects of Maternal Nutrition During Pregnancy and Breast Feeding on the Risk of Allergic Disease in Child | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
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| 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:
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 600 | ||||
| Estimated Completion Date | September 2010 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Finland | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00167700 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 15214 | ||||
| Study Sponsor ICMJE | University of Turku | ||||
| Collaborators ICMJE | Academy of Finland | ||||
| Investigators ICMJE |
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| Information Provided By | University of Turku | ||||
| Verification Date | June 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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