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

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ClinicalTrials.gov Identifier: NCT00167700
Recruitment Status : Unknown
Verified September 2012 by University of Turku.
Recruitment status was:  Recruiting
First Posted : September 14, 2005
Last Update Posted : October 4, 2012
Academy of Finland
Information provided by:
University of Turku

Brief Summary:

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 or disease Intervention/treatment Phase
Allergic Disease Obesity Immunology Behavioral: Dietary counselling and placebo Behavioral: Dietary counselling and probiotics Dietary Supplement: Placebo capsules Dietary Supplement: Probiotics Dietary Supplement: Prebiotics Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : February 1997
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Innate immune gene expression patterns [ Time Frame: Up to 13 years ]
  2. 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.

  3. Plasma glucose [ Time Frame: Up to 13 years ]
  4. Cytokines in peripheral blood [ Time Frame: Up to 13 years ]
  5. Cytokine profile in breast milk [ Time Frame: Up to 13 years ]
  6. Cytokine profile in peripheral blood mononuclear cells (PBMC) [ Time Frame: Up to 13 years ]
  7. GHbA1c [ Time Frame: Up to 13 years ]
  8. Fatty acids [ Time Frame: Up to 13 years ]
  9. Lipoproteins [ Time Frame: Up to 13 years ]
  10. Intakes of foods and nutrients [ Time Frame: Up to 13 years ]
  11. Blood pressure [ Time Frame: Up to 13 years ]
  12. Leukotrienes in peripheral blood [ Time Frame: Up to 13 years ]
  13. Adipokines [ Time Frame: Up to 13 years ]
  14. Amount of crying in minutes [ Time Frame: Up to 1 year ]
    Crying minutes per day

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00167700

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

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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: 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
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Study Director: Erika Isolauri, MD, PhD University of Turku
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00167700    
Other Study ID Numbers: 15214
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: October 4, 2012
Last Verified: September 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:
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Nutrition Disorders
Body Weight
Immune System Diseases