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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University of Turku
Sponsor:
Collaborator:
Academy of Finland
Information provided by:
University of Turku
ClinicalTrials.gov Identifier:
NCT00167700
First received: September 11, 2005
Last updated: October 3, 2012
Last verified: September 2012
  Purpose

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
Obesity
Immunology
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
  • Weight gain [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
  • Number of patients with chronic inflammatory disease [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Innate immune gene expression patterns [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
  • Microbiota composition [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Cytokines in peripheral blood [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
  • Cytokine profile in breast milk [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
  • Cytokine profile in peripheral blood mononuclear cells (PBMC) [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
  • GHbA1c [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
  • Fatty acids [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
  • Lipoproteins [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
  • Intakes of foods and nutrients [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
  • Leukotrienes in peripheral blood [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
  • Adipokines [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
  • Amount of crying in minutes [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Crying minutes per day

  • Number of patients with functional gastrointestinal disorders [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
  • Incidence of viral infections [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]

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

  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
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 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: 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
Investigators
Study Director: Erika Isolauri, MD, PhD University of Turku
  More Information

Additional Information:
Publications:

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

ClinicalTrials.gov Identifier: NCT00167700     History of Changes
Other Study ID Numbers: 15214
Study First Received: September 11, 2005
Last Updated: October 3, 2012
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

Additional relevant MeSH terms:
Hypersensitivity
Obesity
Overweight
Immune System Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014