|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | University of Turku |
|---|---|
| Collaborator: |
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 |
| 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.
|
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:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Johanna Hvitfelt-Koskelainen, RN | +358 2 313 0000 ext 1463 | Johanna.Hvitfelt-Koskelainen@tyks.fi |
| 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 | |
| Study Director: | Erika Isolauri, MD, PhD | University of Turku |
More Information
| 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 |
|
atopic disease probiotics gut microbiota allergy nutrition |
growth allergic rhinitis atopic sensitization risk-markers of life-style related diseases |
|
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 |