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

October 3, 2012 updated by: University of Turku

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

While allergic diseases comprise the most common chronic disease in childhood, obesity is the most prevalent nutritional disorder among children throughout the world. In Europe, an estimated 20% of children and adolescents are overweight with one-third of these being considered obese. Moreover, escalation of these problems is expected in the future, since the velocity of propagation is highest in children. Although genetic factors can determine the propensity of an individual to become allergic or obese, these unlikely explain the recent and progressive worldwide increases in incidence. Rather, it would appear that the environmental changes more directly shape the risk during a critical period of life when the scene is set for the consolidation of the immune responder type. Prenatal environmental exposures may alter gene expression via epigenetic mechanisms, heritable changes in gene expression occurring without alterations in the DNA sequences.

Specifically current research interest is directed towards health promotion and reducing the risk of disease evaluating the probiotic effects with specific foods and nutrients, and assessing their interactions in optimal combination and food matrix. For this purpose a series of interventions studies evaluate the both the optimal timing of probiotic intervention and the optimal mode of administration.

Sections:

Prenatal

RCT 2 Randomized, parallel-design clinical trial of 3 groups. Pregnant women (n=256) from families with at least one member having an allergic disease have been recruited from maternal welfare clinics and randomly assigned to control group or one of the intervention groups. Mothers in the dietary intervention groups received dietary counselling with specific attention to the quality and quantity of fat in the diet. To promote the achievement of current dietary recommendations, mothers have been provided with foods which have a favourable fat composition (e.g. spreads). The subjects in the intervention groups have been further randomized (double-blind randomization) to receive either placebo or a probiotic preparation, 1010 cfu of both Lactobacillus rhamnosus GG and Bifidobacterium lactis and controls received placebo in a single-blind manner. Dietary food products and probiotic supplementation have been continued from the 1st trimester of pregnancy until the end of exclusive breast feeding, maximum of 6 months.

Perinatal

RCT 1 Randomized double-blind, placebo-controlled study of 2 groups. Pregnant women (n=159) have been randomized into one of the study groups 2-4 weeks before term to receive placebo (microcrystalline cellulose) or probiotic Lactobacillus rhamnosus GG (ATCC 53103; 1010 cfu). After delivery probiotics/ placebo were administered orally to the infants for 6 months. General information to prevent allergy has been given in written form to all: to breast-feed for at least 4-6 months; to begin solid foods at 4-6 months; no smoking by caretakers.

RCT 3 Randomized double-blind, placebo-controlled clinical trial of 3 groups. Pregnant women (n=241) with a history of atopic diseases have been assigned to one of the treatment groups: to receive for 2 months before delivery and for 2 months thereafter, when they are breast-feeding, either placebo or Lactobacillus rhamnosus and Bifidobacterium longum or Lactobacillus paracasei and Bifidobacterium longum.

Postnatal

RCT 4 Randomized double-blind, placebo-controlled study of 3 groups. Neonates (n=94) fulfilling the following criteria: gestational age at birth between 32nd and 36th weeks, weight over 1500 g and no congenital defects of gastrointestinal system or other defects that prevent enteral nutrition, have been randomized to receive either placebo (microcrystalline cellulose) or a probiotic preparation (Lactobacillus rhamnosus GG, ATCC 53103) or a prebiotic preparation (a mixture of Polydextrose and Galacto-oligosaccharideOS in a 1:1 ratio). The treatment continues for 2 months.

RCT 5 Randomized double-blind, placebo-controlled clinical trial of 2 groups. 2-6 weeks old formula- and breast-fed colic infants (n=30), who cry without medical cause for 3h/d, for 3days/week, have been randomized to receive either placebo (microcrystalline cellulose) or a probiotic preparation (Lactobacillus rhamnosus GG, ATCC 53103) for 4 weeks. Formula-fed infants receive extensively hydrolysed formula and mothers of breast-fed infants avoid cow's milk in their diet.

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
      • Turku, Finland, 20520
        • Recruiting
        • Turku University Central Hospital
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Dietary supplement: Placebo capsules
Placebo capsules
NO_INTERVENTION: Control
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with allergic disease
Time Frame: Up to 13 years
Up to 13 years
Weight gain
Time Frame: Up to 13 years
Up to 13 years
Number of patients with chronic inflammatory disease
Time Frame: Up to 13 years
Up to 13 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Innate immune gene expression patterns
Time Frame: Up to 13 years
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
Up to 13 years
Cytokines in peripheral blood
Time Frame: Up to 13 years
Up to 13 years
Cytokine profile in breast milk
Time Frame: Up to 13 years
Up to 13 years
Cytokine profile in peripheral blood mononuclear cells (PBMC)
Time Frame: Up to 13 years
Up to 13 years
GHbA1c
Time Frame: Up to 13 years
Up to 13 years
Fatty acids
Time Frame: Up to 13 years
Up to 13 years
Lipoproteins
Time Frame: Up to 13 years
Up to 13 years
Intakes of foods and nutrients
Time Frame: Up to 13 years
Up to 13 years
Blood pressure
Time Frame: Up to 13 years
Up to 13 years
Leukotrienes in peripheral blood
Time Frame: Up to 13 years
Up to 13 years
Adipokines
Time Frame: Up to 13 years
Up to 13 years
Amount of crying in minutes
Time Frame: Up to 1 year
Crying minutes per day
Up to 1 year
Number of patients with functional gastrointestinal disorders
Time Frame: Up to 13 years
Up to 13 years
Incidence of viral infections
Time Frame: Up to 13 years
Up to 13 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Collaborators

Academy of Finland

Investigators

  • Study Director: Erika Isolauri, MD, PhD, University of Turku

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1997

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (ESTIMATE)

September 14, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

October 4, 2012

Last Update Submitted That Met QC Criteria

October 3, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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