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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00167700
First Posted: September 14, 2005
Last Update Posted: October 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Academy of Finland
Information provided by:
University of Turku
  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
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

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
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


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:
Kalliomäki M, Salminen S, Arvilommi H, Kero P, Koskinen P, Isolauri E. Probiotics in primary prevention of atopic disease: a randomised placebo-controlled trial. Lancet. 2001 Apr 7;357(9262):1076-9.
Kalliomäki M, Salminen S, Poussa T, Arvilommi H, Isolauri E. Probiotics and prevention of atopic disease: 4-year follow-up of a randomised placebo-controlled trial. Lancet. 2003 May 31;361(9372):1869-71.
Laiho K, Lampi AM, Hamalainen M, Moilanen E, Piironen V, Arvola T, Syrjanen S, Isolauri E. Breast milk fatty acids, eicosanoids, and cytokines in mothers with and without allergic disease. Pediatr Res. 2003 Apr;53(4):642-7. Epub 2003 Jan 29.
Laitinen K, Kalliomäki M, Poussa T, Lagström H, Isolauri E. Evaluation of diet and growth in children with and without atopic eczema: follow-up study from birth to 4 years. Br J Nutr. 2005 Oct;94(4):565-74.
Collado MC, Laitinen K, Salminen S, Isolauri E. Maternal weight and excessive weight gain during pregnancy modify the immunomodulatory potential of breast milk. Pediatr Res. 2012 Jul;72(1):77-85. doi: 10.1038/pr.2012.42. Epub 2012 Mar 27.
Laitinen K, Poussa T, Isolauri E; Nutrition, Allergy, Mucosal Immunology and Intestinal Microbiota Group. Probiotics and dietary counselling contribute to glucose regulation during and after pregnancy: a randomised controlled trial. Br J Nutr. 2009 Jun;101(11):1679-87. doi: 10.1017/S0007114508111461. Epub 2008 Nov 19.
Hoppu U, Isolauri E, Laakso P, Matomäki J, Laitinen K. Probiotics and dietary counselling targeting maternal dietary fat intake modifies breast milk fatty acids and cytokines. Eur J Nutr. 2012 Mar;51(2):211-9. doi: 10.1007/s00394-011-0209-0. Epub 2011 May 31.
Niinivirta K, Isolauri E, Laakso P, Linderborg K, Laitinen K. Dietary counseling to improve fat quality during pregnancy alters maternal fat intake and infant essential fatty acid status. J Nutr. 2011 Jul;141(7):1281-5. doi: 10.3945/jn.110.137083. Epub 2011 May 18.
Ilmonen J, Isolauri E, Poussa T, Laitinen K. Impact of dietary counselling and probiotic intervention on maternal anthropometric measurements during and after pregnancy: a randomized placebo-controlled trial. Clin Nutr. 2011 Apr;30(2):156-64. doi: 10.1016/j.clnu.2010.09.009.
Luoto R, Laitinen K, Nermes M, Isolauri E. Impact of maternal probiotic-supplemented dietary counseling during pregnancy on colostrum adiponectin concentration: a prospective, randomized, placebo-controlled study. Early Hum Dev. 2012 Jun;88(6):339-44. doi: 10.1016/j.earlhumdev.2011.09.006. Epub 2011 Sep 25.
Ojala T, Aaltonen J, Siira S, Jalonen J, Ekholm E, Ekblad U, Laitinen K. Fetal cardiac sympathetic activation is linked with maternal body mass index. Early Hum Dev. 2009 Sep;85(9):557-60. doi: 10.1016/j.earlhumdev.2009.05.009. Epub 2009 Jun 12.
Luoto R, Laitinen K, Nermes M, Isolauri E. Impact of maternal probiotic-supplemented dietary counselling on pregnancy outcome and prenatal and postnatal growth: a double-blind, placebo-controlled study. Br J Nutr. 2010 Jun;103(12):1792-9. doi: 10.1017/S0007114509993898. Epub 2010 Feb 4.
Collado MC, Isolauri E, Laitinen K, Salminen S. Effect of mother's weight on infant's microbiota acquisition, composition, and activity during early infancy: a prospective follow-up study initiated in early pregnancy. Am J Clin Nutr. 2010 Nov;92(5):1023-30. doi: 10.3945/ajcn.2010.29877. Epub 2010 Sep 15.
Aaltonen J, Ojala T, Laitinen K, Poussa T, Ozanne S, Isolauri E. Impact of maternal diet during pregnancy and breastfeeding on infant metabolic programming: a prospective randomized controlled study. Eur J Clin Nutr. 2011 Jan;65(1):10-9. doi: 10.1038/ejcn.2010.225. Epub 2010 Oct 13.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Pärtty A, Lehtonen L, Kalliomäki M, Salminen S, Isolauri E. Probiotic Lactobacillus rhamnosus GG therapy and microbiological programming in infantile colic: a randomized, controlled trial. Pediatr Res. 2015 Oct;78(4):470-5. doi: 10.1038/pr.2015.127. Epub 2015 Jul 7.
Luoto R, Ruuskanen O, Waris M, Kalliomäki M, Salminen S, Isolauri E. Prebiotic and probiotic supplementation prevents rhinovirus infections in preterm infants: a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2014 Feb;133(2):405-13. doi: 10.1016/j.jaci.2013.08.020. Epub 2013 Oct 13.
Pärtty A, Luoto R, Kalliomäki M, Salminen S, Isolauri E. Effects of early prebiotic and probiotic supplementation on development of gut microbiota and fussing and crying in preterm infants: a randomized, double-blind, placebo-controlled trial. J Pediatr. 2013 Nov;163(5):1272-7.e1-2. doi: 10.1016/j.jpeds.2013.05.035. Epub 2013 Jul 31.
Cabrera-Rubio R, Collado MC, Laitinen K, Salminen S, Isolauri E, Mira A. The human milk microbiome changes over lactation and is shaped by maternal weight and mode of delivery. Am J Clin Nutr. 2012 Sep;96(3):544-51. doi: 10.3945/ajcn.112.037382. Epub 2012 Jul 25.
Grześkowiak Ł, Collado MC, Mangani C, Maleta K, Laitinen K, Ashorn P, Isolauri E, Salminen S. Distinct gut microbiota in southeastern African and northern European infants. J Pediatr Gastroenterol Nutr. 2012 Jun;54(6):812-6. doi: 10.1097/MPG.0b013e318249039c.
Grześkowiak Ł, Grönlund MM, Beckmann C, Salminen S, von Berg A, Isolauri E. The impact of perinatal probiotic intervention on gut microbiota: double-blind placebo-controlled trials in Finland and Germany. Anaerobe. 2012 Feb;18(1):7-13. doi: 10.1016/j.anaerobe.2011.09.006. Epub 2011 Sep 29.
Huurre A, Kalliomäki M, Rautava S, Rinne M, Salminen S, Isolauri E. Mode of delivery - effects on gut microbiota and humoral immunity. Neonatology. 2008;93(4):236-40. Epub 2007 Nov 16.

ClinicalTrials.gov Identifier: NCT00167700     History of Changes
Other Study ID Numbers: 15214
First Submitted: September 11, 2005
First Posted: September 14, 2005
Last Update Posted: October 4, 2012
Last Verified: September 2012

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:
Overweight
Hypersensitivity
Body Weight
Signs and Symptoms
Immune System Diseases


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