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

NCT00167700 | Unknown

• 1 other identifier: 15214
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Disease; Obesity; Immunology

Keywords

atopic disease; probiotics; gut microbiota; allergy; nutrition; growth; allergic rhinitis; atopic sensitization; risk-markers of life-style related diseases

Outcome Measures

Primary Outcomes (3)

• Number of participants with allergic disease

  Up to 13 years

• Weight gain

  Up to 13 years

• Number of patients with chronic inflammatory disease

  Up to 13 years

Secondary Outcomes (16)

• Innate immune gene expression patterns

  Up to 13 years

• Microbiota composition

• Plasma glucose

  Up to 13 years

• Cytokines in peripheral blood

  Up to 13 years

• Cytokine profile in breast milk

  Up to 13 years

Study Arms (6)

Probiotics

EXPERIMENTAL

Dietary Supplement: Probiotics

Probiotics + Dietary counseling

EXPERIMENTAL

Behavioral: Dietary counselling and probiotics

Dietary counseling + placebo

EXPERIMENTAL

Behavioral: Dietary counselling and placebo

Prebiotics

EXPERIMENTAL

Dietary Supplement: Prebiotics

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo capsules

Control

NO INTERVENTION

Interventions

Dietary counselling and placebo BEHAVIORAL

Counseling to conform with the dietary recommendations. Food products commercially available including spreads and salad dressing. Placebo capsules.

Dietary counseling + placebo

Dietary counselling and probiotics BEHAVIORAL

Counseling to conform with the dietary recommendations. Food products commercially available including spreads and salad dressing. Probiotics

Probiotics + Dietary counseling

Placebo capsules DIETARY_SUPPLEMENT

Placebo capsules

Placebo

Probiotics DIETARY_SUPPLEMENT

Probiotics

Prebiotics DIETARY_SUPPLEMENT

Prebiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women from families with at least one family member having an allergic disease

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Turku: lead
• Academy of Finland: collaborator

Study Sites (1)

Turku University Central Hospital

Turku, 20520, Finland

RECRUITING

Related Publications (24)

• Kalliomaki 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. doi: 10.1016/S0140-6736(00)04259-8.

  PMID: 11297958 RESULT

• Kalliomaki 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. doi: 10.1016/S0140-6736(03)13490-3.

  PMID: 12788576 RESULT

• 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. doi: 10.1203/01.PDR.0000055778.58807.C8. Epub 2003 Jan 29.

  PMID: 12612204 RESULT

• Laitinen K, Kalliomaki M, Poussa T, Lagstrom 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. doi: 10.1079/bjn20051503.

  PMID: 16197582 RESULT

• 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.

  PMID: 22453296 RESULT

• 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.

  PMID: 19017418 RESULT

• Hoppu U, Isolauri E, Laakso P, Matomaki 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.

  PMID: 21626296 RESULT

• 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.

  PMID: 21593355 RESULT

• 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.

  PMID: 20970896 RESULT

• 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.

  PMID: 21945174 RESULT

• 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.

  PMID: 19524376 RESULT

• 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.

  PMID: 20128938 RESULT

• 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.

  PMID: 20844065 RESULT

• 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.

  PMID: 20948557 RESULT

• Luoto R, Partty A, Vogt JK, Rautava S, Isolauri E. Reversible aberrancies in gut microbiome of moderate and late preterm infants: results from a randomized, controlled trial. Gut Microbes. 2023 Dec;15(2):2283913. doi: 10.1080/19490976.2023.2283913. Epub 2023 Nov 27.

  PMID: 38010080 DERIVED

• Davidson SJ, Barrett HL, Price SA, Callaway LK, Dekker Nitert M. Probiotics for preventing gestational diabetes. Cochrane Database Syst Rev. 2021 Apr 19;4(4):CD009951. doi: 10.1002/14651858.CD009951.pub3.

  PMID: 33870484 DERIVED

• Partty A, Kalliomaki M, Salminen S, Isolauri E. Infantile Colic Is Associated With Low-grade Systemic Inflammation. J Pediatr Gastroenterol Nutr. 2017 May;64(5):691-695. doi: 10.1097/MPG.0000000000001340.

  PMID: 27478897 DERIVED

• Partty A, Lehtonen L, Kalliomaki 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.

  PMID: 26151493 DERIVED

• Luoto R, Ruuskanen O, Waris M, Kalliomaki 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.

  PMID: 24131826 DERIVED

• Partty A, Luoto R, Kalliomaki 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.

  PMID: 23915796 DERIVED

• 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.

  PMID: 22836031 DERIVED

• Grzeskowiak L, 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.

  PMID: 22228076 DERIVED

• Grzeskowiak L, Gronlund 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.

  PMID: 21979491 DERIVED

• Huurre A, Kalliomaki 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. doi: 10.1159/000111102. Epub 2007 Nov 16.

  PMID: 18025796 DERIVED

MeSH Terms

Conditions

Obesity; Hypersensitivity; Rhinitis, Allergic

Interventions

Probiotics; Prebiotics

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Immune System Diseases; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides

Study Officials

• Erika Isolauri, MD, PhD

  University of Turku

  STUDY DIRECTOR

Central Study Contacts

Johanna Hvitfelt-Koskelainen, RN

CONTACT

+358 2 313 0000; Johanna.Hvitfelt-Koskelainen@tyks.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2005
• First Posted: September 14, 2005
• Study Start: February 1, 1997
• Study Completion: December 1, 2015
• Last Updated: October 4, 2012

Record last verified: 2012-09

Locations

FI (1)