AsthmaNCT00159523
Impact in Off-spring of Mothers After Perinatal Daily Intake of a Probiotic
A study testing Probiotic in people with Asthma and Dermatitis, Atopic, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
A probiotic (Lactobacillus rhamnosus GG) supplement to pregnant women the last four weeks of pregnancy and three months after birth is expected to give a 40% reduction in risk of atopic sensitisation and allergic disease at two years of age, compared to placebo. Read more about this study
- Who is it for?
- Ages 30 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Asthma, Dermatitis, Atopic, Rhinitis, Allergic, Perennial
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 416 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2003to Sep 2007
- 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 30 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All pregnant women understanding Norwegian language and who has signed an informed consent form, can be included.
- Inclusion must take place before week 36 in the pregnancy.
- The woman must plan to breast-feed the first 4 months after birth.
- She must live in Trondheim.
Who cannot join
- Not being able to fill in the questionnaire in Norwegian language
- Lactose intolerance
- Consumption of probiotics earlier in the pregnancy.
- Intention to move from Trondheim in the next 25 months.
- Pregnant women in risk of eclampsia, or other serious disease that can influence beast-feeding or care for the child.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Perinatal Daily Supplement of a Probiotic (Lactobacillus Rhamnosus GG), Given to Mothers, on Immunological Development, Atopic Sensitisation and Allergic Disease in Their Off-spring
A probiotic (Lactobacillus rhamnosus GG) supplement to pregnant women the last four weeks of pregnancy and three months after birth is expected to give a 40% reduction in risk of atopic sensitisation and allergic disease at two years of age, compared to placebo.
Read the detailed description
To investigate how probiotics given to pregnant women during the last 4 weeks of pregnancy and the first 4 months after birth influence the establishment and composition of the gut microflora in children from birth until two years of age.
At the same time to investigate the relationship between gut flora composition and the development of the immune system.
To investigate the relationship between supplement of probiotics to pregnant and breast-feeding women, the microbial composition of the gut flora in their children, the development of the childrens' immune system, and the prevalence of atopic sensitisation and atopic disease at two years of age.
- Conditions
- Asthma, Dermatitis, Atopic, Rhinitis, Allergic, Perennial
- Being tested
- Probiotic, placebo
- Keywords
- Prevention, Probiotics, Allergy, Hypersensitivity
- Medical subject headings
- Asthma, Dermatitis, Atopic, Rhinitis, Allergic, Perennial, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Also called Lactobacillus rhamnosus GG
placeboBiological
| Study group | Role | What they receive |
|---|---|---|
| probiotic | Experimental | Not described Receives: Dietary Supplement: Probiotic |
| placebo | Placebo comparator | Not described Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age
Measured: 2 years
Secondary outcomes (8)
Atopic sensitization
Measured: 2 years
Positive skin prick test (SPT), elevated total IgE and elevated specific IgE
Measured: 2 years
Intestinal microflora
Measured: 2 years
Intestinal colonisation with LGG.
Measured: 2 years
Oral cavity colonisation with LGG.
Measured: 2 years
Immunomarkers
Measured: 2 years
TGF in breastmilk
Measured: 2 years
Cytokine profile from activated PBMC
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Tine, St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Anne Katarina Cartfjord, Director, Study director, Faculty of Medicine, NTNU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159523
- Sponsor's protocol ID
- 097-03
- Status last verified
- Aug 2015
- First submitted
- 8 Sep 2005
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Dotterud CK, Storro O, Johnsen R, Oien T. Probiotics in pregnant women to prevent allergic disease: a randomized, double-blind trial. Br J Dermatol. 2010 Sep;163(3):616-23. doi: 10.1111/j.1365-2133.2010.09889.x. Epub 2010 Jun 9.
PubMed 20545688Simpson MR, Dotterud CK, Storro O, Johnsen R, Oien T. Perinatal probiotic supplementation in the prevention of allergy related disease: 6 year follow up of a randomised controlled trial. BMC Dermatol. 2015 Aug 1;15:13. doi: 10.1186/s12895-015-0030-1.
PubMed 26232126Zakiudin DP, Ro ADB, Videm V, Oien T, Simpson MR. Systemic inflammatory proteins in offspring following maternal probiotic supplementation for atopic dermatitis prevention. Clin Mol Allergy. 2023 Jul 29;21(1):5. doi: 10.1186/s12948-023-00186-3.
PubMed 37516841Schei K, Simpson MR, Avershina E, Rudi K, Oien T, Juliusson PB, Underhill D, Salamati S, Odegard RA. Early Gut Fungal and Bacterial Microbiota and Childhood Growth. Front Pediatr. 2020 Nov 9;8:572538. doi: 10.3389/fped.2020.572538. eCollection 2020.
PubMed 33240830Schei K, Avershina E, Oien T, Rudi K, Follestad T, Salamati S, Odegard RA. Early gut mycobiota and mother-offspring transfer. Microbiome. 2017 Aug 24;5(1):107. doi: 10.1186/s40168-017-0319-x.
PubMed 28837002Simpson MR, Ro AD, Grimstad O, Johnsen R, Storro O, Oien T. Atopic dermatitis prevention in children following maternal probiotic supplementation does not appear to be mediated by breast milk TSLP or TGF-beta. Clin Transl Allergy. 2016 Jul 22;6:27. doi: 10.1186/s13601-016-0119-6. eCollection 2016.
PubMed 27453775Simpson MR, Brede G, Johansen J, Johnsen R, Storro O, Saetrom P, Oien T. Human Breast Milk miRNA, Maternal Probiotic Supplementation and Atopic Dermatitis in Offspring. PLoS One. 2015 Dec 14;10(12):e0143496. doi: 10.1371/journal.pone.0143496. eCollection 2015.
PubMed 26657066Dotterud CK, Avershina E, Sekelja M, Simpson MR, Rudi K, Storro O, Johnsen R, Oien T. Does Maternal Perinatal Probiotic Supplementation Alter the Intestinal Microbiota of Mother and Child? J Pediatr Gastroenterol Nutr. 2015 Aug;61(2):200-7. doi: 10.1097/MPG.0000000000000781.
PubMed 25782657
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Perinatal Daily Supplement of a Probiotic (Lactobacillus Rhamnosus GG), Given to Mothers, on Immunological Development, Atopic Sensitisation and Allergic Disease in Their Off-spring
- ClinicalTrials.gov ID
- NCT00159523
- Acronym / sponsor ID
- 097-03
- Conditions
- Asthma, Dermatitis, Atopic, Rhinitis, Allergic, Perennial
- Keywords
- Prevention, Probiotics, Allergy, Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Tine, St. Olavs Hospital
- Study start
- Dec 2003
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A probiotic (Lactobacillus rhamnosus GG) supplement to pregnant women the last four weeks of pregnancy and three months after birth is expected to give a 40% reduction in risk of atopic sensitisation and allergic disease at two years of age, compared to placebo.
Detailed description
To investigate how probiotics given to pregnant women during the last 4 weeks of pregnancy and the first 4 months after birth influence the establishment and composition of the gut microflora in children from birth until two years of age.
At the same time to investigate the relationship between gut flora composition and the development of the immune system.
To investigate the relationship between supplement of probiotics to pregnant and breast-feeding women, the microbial composition of the gut flora in their children, the development of the childrens' immune system, and the prevalence of atopic sensitisation and atopic disease at two years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotic | Experimental | Dietary Supplement: Probiotic |
| placebo | Placebo comparator | Biological: placebo |
Who may qualify
- Ages
- 30 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- All pregnant women understanding Norwegian language and who has signed an informed consent form, can be included.
- Inclusion must take place before week 36 in the pregnancy.
- The woman must plan to breast-feed the first 4 months after birth.
- She must live in Trondheim.
Key exclusion criteria (5 listed)
- Not being able to fill in the questionnaire in Norwegian language
- Lactose intolerance
- Consumption of probiotics earlier in the pregnancy.
- Intention to move from Trondheim in the next 25 months.
- Pregnant women in risk of eclampsia, or other serious disease that can influence beast-feeding or care for the child.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticAlso: Lactobacillus rhamnosus GG | Dietary supplement | probiotic |
| placebo | Biological | placebo |
Primary outcome
Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age
Time frame: 2 years
8 secondary outcomes
Atopic sensitization
Time frame: 2 years
Positive skin prick test (SPT), elevated total IgE and elevated specific IgE
Time frame: 2 years
Intestinal microflora
Time frame: 2 years
Intestinal colonisation with LGG.
Time frame: 2 years
Oral cavity colonisation with LGG.
Time frame: 2 years
Immunomarkers
Time frame: 2 years
TGF in breastmilk
Time frame: 2 years
Cytokine profile from activated PBMC
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
- Results publication: PubMed 20545688Dotterud CK, Storro O, Johnsen R, Oien T. Probiotics in pregnant women to prevent allergic disease: a randomized, double-blind trial. Br J Dermatol. 2010 Sep;163(3):616-23. doi: 10.1111/j.1365-2133.2010.09889.x. Epub 2010 Jun 9.
- Results publication: PubMed 26232126Simpson MR, Dotterud CK, Storro O, Johnsen R, Oien T. Perinatal probiotic supplementation in the prevention of allergy related disease: 6 year follow up of a randomised controlled trial. BMC Dermatol. 2015 Aug 1;15:13. doi: 10.1186/s12895-015-0030-1.
- Derived from this study: PubMed 37516841Zakiudin DP, Ro ADB, Videm V, Oien T, Simpson MR. Systemic inflammatory proteins in offspring following maternal probiotic supplementation for atopic dermatitis prevention. Clin Mol Allergy. 2023 Jul 29;21(1):5. doi: 10.1186/s12948-023-00186-3.
- Derived from this study: PubMed 33240830Schei K, Simpson MR, Avershina E, Rudi K, Oien T, Juliusson PB, Underhill D, Salamati S, Odegard RA. Early Gut Fungal and Bacterial Microbiota and Childhood Growth. Front Pediatr. 2020 Nov 9;8:572538. doi: 10.3389/fped.2020.572538. eCollection 2020.
- Derived from this study: PubMed 28837002Schei K, Avershina E, Oien T, Rudi K, Follestad T, Salamati S, Odegard RA. Early gut mycobiota and mother-offspring transfer. Microbiome. 2017 Aug 24;5(1):107. doi: 10.1186/s40168-017-0319-x.
- Derived from this study: PubMed 27453775Simpson MR, Ro AD, Grimstad O, Johnsen R, Storro O, Oien T. Atopic dermatitis prevention in children following maternal probiotic supplementation does not appear to be mediated by breast milk TSLP or TGF-beta. Clin Transl Allergy. 2016 Jul 22;6:27. doi: 10.1186/s13601-016-0119-6. eCollection 2016.
- Derived from this study: PubMed 26657066Simpson MR, Brede G, Johansen J, Johnsen R, Storro O, Saetrom P, Oien T. Human Breast Milk miRNA, Maternal Probiotic Supplementation and Atopic Dermatitis in Offspring. PLoS One. 2015 Dec 14;10(12):e0143496. doi: 10.1371/journal.pone.0143496. eCollection 2015.
- Derived from this study: PubMed 25782657Dotterud CK, Avershina E, Sekelja M, Simpson MR, Rudi K, Storro O, Johnsen R, Oien T. Does Maternal Perinatal Probiotic Supplementation Alter the Intestinal Microbiota of Mother and Child? J Pediatr Gastroenterol Nutr. 2015 Aug;61(2):200-7. doi: 10.1097/MPG.0000000000000781.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Katarina Cartfjord, Director study director
Faculty of Medicine, NTNU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Asthma and Dermatitis, Atopic, run by Norwegian University of Science and Technology at 1 site in Norway.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 5 Feb 2016. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age (time frame: 2 years). 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 NCT00159523, which also lists 8 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 Feb 2016.