CClinicalTrials.gg
Status unknownNCT01542970PROOM-3Updated Mar 5, 2012

Can Supplementation With Lactobacillus Reuteri and Omega-3 Fatty Acids During Pregnancy and Lactation Reduce the Risk of Allergic Disease in Infancy?

An interventional study of Placebo and Omega-3 fatty acids in Allergy and Gastrointestinal Function, sponsored by Ostergotland County Council, Sweden. Status unknown at 1 site in Sweden. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-05.

Sponsored by Ostergotland County Council, Sweden · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
496
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

The incidence of allergic disease has increased worldwide during the last decades. Initially, a lot of effort has been put in elucidating which of the known risk factors commonly associated to the development of allergic disease early in life was the cause of this increase. Studies showing a reduced incidence of allergic disease in the former socialist countries in comparison to countries with a "Western lifestyle" have shown that risk factors as allergen exposure, environmental pollution and tobacco exposure are also present in societies with a less affluent lifestyle. This suggests the disappearance of factor protecting against the development of allergic diseases in affluent environment.The development of allergic diseases begins during the first year of life with eczema, both non-IgE- and IgE-associated, and food allergy, progressing during childhood with the development of asthma bronchiale, also both non-IgE- and IgE-associated, and later development of allergic rhinoconjunctivitis, i.e. the atopic march. The immune system of the neonate is influenced by maternal immunity, both via the placenta and breast milk. Thus, the immunological interaction between the mother and her offspring is close during pregnancy and lactation. The association of cord blood IgE levels with maternal but not paternal atopic heredity, may depend on a possibly stronger placental Th2 shift in atopic mothers. Thus, factors influencing/protecting against the development of allergic disease early in life, would be important already during pregnancy, birth and early postnatal life. Two major hypotheses have been assessed during the last decade: Proper microbial stimulation, including the establishment of the gut flora in infancy and the relationship between low omega 3-polyunsaturated fatty acids in the western diet and the incidence of allergic disease.

This is a double blind randomized study. Families with at least one parent/sibling with clinical symptoms/history of allergic disease will be invited to participate in this study. Pregnant mothers will be included in the study at the 20th week of gestation. They will be randomized to 4 study groups, one will receive placebo capsules, the second will receive omega-3 PUFA supplementation and placebo regarding L. reuteri, the third will receive L. reuteri and placebo regarding omega-3 PUFA and the fourth group will receive both omega-3 PUFA and L. reuteri supplementation. Omega-3 supplementation will be given to mothers from pregnancy and lactation while L. reuteri will be given to the mothers during pregnancy and later to the children during the first year of life.The children will be clinically followed by an allergy nurse regularly. Questionnaires regarding data on environment, siblings, pets, breast feeding, smoking exposure, upper respiratory and other infections and clinical symptoms of allergic disease will be filled regularly. Skin prick tests (SPTs) will be performed in the children at 6 and 12 months with milk, egg, wheat, peanut and cat. At 24 months, timothy and birch allergen extracts will be added. A pediatrician will assess the children at 24 months of life and whenever it is needed during the study period. Dietary habits will be assessed during pregnancy (25th gestational week) and 6 months after child birth. Blood samples in the children will be taken from cord blood and at 6, 12 and 24 months of life. Maternal blood samples will be taken at 20th weeks of gestation and at child birth. Milk samples will be collected 1-4 days after partus and monthly during the first 4 months of lactation. Maternal gastrointestinal function will be addressed by validated diary cards. Saliva from the children and fecal samples from mother and child will also be collected according to the following protocol.

02

Conditions studied

  • Allergy
  • Gastrointestinal Function

Keywords

  • intervention
  • lactobacillus reuteri
  • omega-3 fatty acids
  • pregnancy
  • lactation
  • allergic symptoms
  • IgE associated disease
  • gastrointestinal function
03

In context

Lead sponsor

Ostergotland County Council, Sweden is the lead sponsor of 17 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • pregnant women expecting a child with at least one parent or a sibling with clinical symptoms/history of allergic disease
  • breastfeeding for at least 3 months is mandatory for inclusion in the statistical assessment in the study

Exclusion criteria

Exclusion Criteria:

  • mothers with fish allergy
  • twin pregnancy
  • mothers previously/currently using omega-3 PUFA or probiotic dietary supplementation
  • children born before gestational week 33 or seriously ill will be excluded from the study.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
496 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Placebo for both L. reuteri and omega-3 fatty acids.

    Dietary Supplement: Placebo · Dietary Supplement: Refined coconut and peanut oil without L. reuteri

  • Experimental
    L. reuteri and placebo

    Active Lactobacillus reuteri and placebo for omega-3 fatty acids

    Dietary Supplement: Placebo · Dietary Supplement: L. reuteri

  • Experimental
    Omega-3 fatty acids and placebo

    Placebo for L. reuteri and active for omega-3 fatty acids

    Dietary Supplement: Omega-3 fatty acids · Dietary Supplement: Refined coconut and peanut oil without L. reuteri

  • Experimental
    L. reuteri and omega-3 fatty acids

    Active L. reuteri and active omega-3 fatty acids

    Dietary Supplement: L. reuteri

Interventions

  • Dietary supplementPlacebo

    Olive oil

  • Dietary supplementOmega-3 fatty acids

    Omega-3 PUFA treatment comprises of maternal supplementation of 3 capsules of Pikasol® (1g capsules containing 640 mg ω-3 PUFA) 2 times daily during pregnancy and lactation.

  • Dietary supplementRefined coconut and peanut oil without L. reuteri

    2x20 drops daily to the mother from gw 20 and from birth to the child during the first year of life

  • Dietary supplementL. reuteri

    The L. reuteri supplementation comprises of L. reuteri suspension 109 colony forming units (CFU) in oil (refined coconut and peanut oil) (20 droplets x 2 daily) to the mothers during pregnancy and 108 CFU (5 droplets x 1) to the children during the first years of life

06

What researchers measure

Primary outcomes

  1. IgE associated disease

    A food reaction is defined as gastrointestinal symptoms, hives, aggravated eczema or wheezing following ingestion of a certain food with recovery after food elimination from the diet and reoccurrence of symptoms after ingestion of the particular food. Eczema is characterized as reoccurring, itching eczematous and lichenified or nummular dermatitis. Doctor diagnosed wheezing at least three times during the first two years is required for the diagnosis of asthma. If specific positive SPT or serum IgE antibodies is present, the food reaction, eczema in defined as IgE associated.

    Time frame: 2 years of age

Secondary outcomes

  1. Maternal gastrointestinal function

    Maternal gastrointestinal function will be addressed by validated diary cards. The mothers will record every single stool, stool consistency, and corresponding defecatory symptoms (urgency, straining, and feeling of incomplete evacuation) for seven days at gestational week 25 and 35. Stool consistency will be defined by the Bristol Stool Form Scale. The mothers will also record every meal, and episodes (start and ending time) of abdominal pain and bloating.

    Time frame: 20th gestational week to 6 months post partum

07

Study locations

1 of 1 sites recruiting
  • Allergicentrum, Universitetssjukhuset
    Linköping, 58185, Sweden
    Recruiting
08

References and documents

Publications

  • Huoman J, Martinez-Enguita D, Olsson E, Ernerudh J, Nilsson L, Duchen K, Gustafsson M, Jenmalm MC. Combined prenatal Lactobacillus reuteri and omega-3 supplementation synergistically modulates DNA methylation in neonatal T helper cells. Clin Epigenetics. 2021 Jun 30;13(1):135. doi: 10.1186/s13148-021-01115-4. PubMed 34193262 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01542970
Lead sponsor
Ostergotland County Council, Sweden
Responsible party
Karel Duchén, MD (MD, Ostergotland County Council, Sweden) — Principal investigator
First posted
Mar 2, 2012
Start date
Feb 2012
Primary completion
Jun 2017 (estimated)
Completion
Jun 2017 (estimated)
Last update
Mar 5, 2012

Study contacts

Karel M Duchén, MD, PhD
Contact
Karel.Duchen.Munoz@lio.se
+46-10-103 1355
Karel M Duchén, MD, PhD
principal investigator · Ostergotland County Council, Sweden
Maria C Jenmalm, PhD
principal investigator · Linkoeping University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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