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Pre-, Peri- and Postnatal Programming and Origins of Disease: Early Targeting the Epidemics of Allergy and Overweight (NAMI)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by University of Turku.
Recruitment status was:  Recruiting
Academy of Finland
Information provided by:
University of Turku Identifier:
First received: September 11, 2005
Last updated: October 3, 2012
Last verified: September 2012

Combined programme: Nutrition, Allergy, Mucosal immunology and Intestinal microbiota (NAMI) was created with the objective to reverse the rising trend of chronic inflammatory diseases, such as allergic disease and obesity, by control of the internal and external environments of the infant. To approach this problem, the project aims to characterize

  • how immunology is regulated during pregnancy and early infancy,
  • how the immune interaction between mother and child is influenced by nutritional and microbial factors, and
  • how the regulation is related to disease risk.

Condition Intervention
Allergic Disease
Behavioral: Dietary counselling and placebo
Behavioral: Dietary counselling and probiotics
Dietary Supplement: Placebo capsules
Dietary Supplement: Probiotics
Dietary Supplement: Prebiotics

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Nutrition, Allergy, Mucosal Immunology and Intestinal Microbiota (NAMI): Pre-, Peri- and Postnatal Programming and Origins of Disease: Early Targeting the Epidemics of Allergy and Overweight

Resource links provided by NLM:

Further study details as provided by University of Turku:

Primary Outcome Measures:
  • Number of participants with allergic disease [ Time Frame: Up to 13 years ]
  • Weight gain [ Time Frame: Up to 13 years ]
  • Number of patients with chronic inflammatory disease [ Time Frame: Up to 13 years ]

Secondary Outcome Measures:
  • Innate immune gene expression patterns [ Time Frame: Up to 13 years ]
  • Microbiota composition
    Amount of bacterial cells (per gram of faeces of mothers and infants as well as of breast milk) is measured using multiple methods, i.e. pyrosequencing, HIT-CHIP, qPCR, FISH and DGGE.

  • Plasma glucose [ Time Frame: Up to 13 years ]
  • Cytokines in peripheral blood [ Time Frame: Up to 13 years ]
  • Cytokine profile in breast milk [ Time Frame: Up to 13 years ]
  • Cytokine profile in peripheral blood mononuclear cells (PBMC) [ Time Frame: Up to 13 years ]
  • GHbA1c [ Time Frame: Up to 13 years ]
  • Fatty acids [ Time Frame: Up to 13 years ]
  • Lipoproteins [ Time Frame: Up to 13 years ]
  • Intakes of foods and nutrients [ Time Frame: Up to 13 years ]
  • Blood pressure [ Time Frame: Up to 13 years ]
  • Leukotrienes in peripheral blood [ Time Frame: Up to 13 years ]
  • Adipokines [ Time Frame: Up to 13 years ]
  • Amount of crying in minutes [ Time Frame: Up to 1 year ]
    Crying minutes per day

  • Number of patients with functional gastrointestinal disorders [ Time Frame: Up to 13 years ]
  • Incidence of viral infections [ Time Frame: Up to 13 years ]

Estimated Enrollment: 800
Study Start Date: February 1997
Estimated Study Completion Date: December 2015
Arms Assigned Interventions
Experimental: Probiotics Dietary Supplement: Probiotics
Experimental: Probiotics + Dietary counseling Behavioral: Dietary counselling and probiotics
Counseling to conform with the dietary recommendations. Food products commercially available including spreads and salad dressing. Probiotics
Experimental: Dietary counseling + placebo Behavioral: Dietary counselling and placebo
Counseling to conform with the dietary recommendations. Food products commercially available including spreads and salad dressing. Placebo capsules.
Experimental: Prebiotics Dietary Supplement: Prebiotics
Placebo Comparator: Placebo Dietary Supplement: Placebo capsules
Placebo capsules
No Intervention: Control

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00167700

Contact: Johanna Hvitfelt-Koskelainen, RN +358 2 313 0000 ext 1463

Turku University Central Hospital Recruiting
Turku, Finland, 20520
Contact: Erika Isolauri, MD, PhD    +358 2 313 0000 ext 2433   
Principal Investigator: Erika Isolauri, MD, PhD         
Principal Investigator: Seppo Salminen, PhD         
Principal Investigator: Kirsi Laitinen, PhD         
Sub-Investigator: Marko Kalliomäki, 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         
Sub-Investigator: Ulla Hoppu, PhD         
Sub-Investigator: Raakel Luoto, MD, PhD         
Sub-Investigator: Jonna Normia, MD, PhD         
Sponsors and Collaborators
University of Turku
Academy of Finland
Study Director: Erika Isolauri, MD, PhD University of Turku
  More Information

Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00167700     History of Changes
Other Study ID Numbers: 15214
Study First Received: September 11, 2005
Last Updated: October 3, 2012

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

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Immune System Diseases processed this record on May 22, 2017