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AzTrials

AllergyPROOM-3NCT01542970

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

A study testing Omega-3 fatty acids, Refined coconut and peanut oil without L. reuteri and L. reuteri in people with Allergy and Gastrointestinal Function, run by Ostergotland County Council, Sweden at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Allergy, Gastrointestinal Function
What is being tested?
Omega-3 fatty acids, Refined coconut and peanut oil without L. reuteri and L. reuteri
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
496 participants
Where
1 siteSweden
Study dates
Feb 2012to Jun 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Karel M Duchén, MD, PhD contact

+46-10-103 1355

Karel.Duchen.Munoz@lio.se

Sweden1 site, 1 recruiting
  • Allergicentrum, Universitetssjukhuset

    Linköping, 58185

    Recruiting

Other trials in Sweden

About this study

Official title: Combined Dietary Supplementation With Lactobacillus Reuteri and Omega-3 PUFA During Pregnancy and Postnatally in Relation to Development of IgE-associated Disease During Infancy

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.

Being tested
Placebo, Omega-3 fatty acids, Refined coconut and peanut oil without L. reuteri, L. reuteri
Keywords
intervention, lactobacillus reuteri, omega-3 fatty acids, pregnancy, lactation, allergic symptoms, IgE associated disease, gastrointestinal function
Medical subject headings
Hypersensitivity, Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDietary supplement

    Olive oil

  • Omega-3 fatty acidsDietary supplement

    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.

  • Refined coconut and peanut oil without L. reuteriDietary supplement

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

  • L. reuteriDietary supplement

    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

Study groups in NCT01542970
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo for both L. reuteri and omega-3 fatty acids.
Receives: Dietary Supplement: Placebo; Dietary Supplement: Refined coconut and peanut oil without L. reuteri
L. reuteri and placeboExperimentalActive Lactobacillus reuteri and placebo for omega-3 fatty acids
Receives: Dietary Supplement: Placebo; Dietary Supplement: L. reuteri
Omega-3 fatty acids and placeboExperimentalPlacebo for L. reuteri and active for omega-3 fatty acids
Receives: Dietary Supplement: Omega-3 fatty acids; Dietary Supplement: Refined coconut and peanut oil without L. reuteri
L. reuteri and omega-3 fatty acidsExperimentalActive L. reuteri and active omega-3 fatty acids
Receives: Dietary Supplement: L. reuteri

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years of age

Secondary outcomes (1)
  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.

    Measured: 20th gestational week to 6 months post partum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionJun 2017 (estimated)
  4. Study completionJun 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
496 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01542970
Sponsor's protocol ID
FaLr-013
Acronym
PROOM-3
Status last verified
Mar 2012
First submitted
27 Feb 2012
Last updated
5 Mar 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Al-Kaabawi A, Landberg E, Marti M, Severin E, Tingo L, Duchen K, Jenmalm MC. Effects of maternal allergy and supplementation with omega-3 fatty acid and probiotic on human milk oligosaccharides. Pediatr Allergy Immunol. 2025 Aug;36(8):e70162. doi: 10.1111/pai.70162.

    PubMed 40747696
  • Ahlberg E, Marti M, Govindaraj D, Severin E, Duchen K, Jenmalm MC, Tingo L. Immune-related microRNAs in breast milk and their relation to regulatory T cells in breastfed children. Pediatr Allergy Immunol. 2023 Apr;34(4):e13952. doi: 10.1111/pai.13952.

    PubMed 37102392
  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Omega-3 fatty acids, Refined coconut and peanut oil without L. reuteri and L. reuteri in people with Allergy and Gastrointestinal Function, run by Ostergotland County Council, Sweden at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Karel M Duchén, MD, PhD (+46-10-103 1355, Karel.Duchen.Munoz@lio.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IgE associated disease (time frame: 2 years of age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01542970, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2012.

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