Allergic ConditionsPhase 2NCT01285830
Primary Prevention of Allergic Disease in Early Child by Lactobacillus Reuteri
A Phase 2 study testing Lactobacillus reuteri in people with Allergic Conditions, run by Linkoeping University at 3 sites in Sweden.
Trial summary
An altered microbial exposure may be partly responsible for the increase of allergic diseases in populations with a western lifestyle. Activation of the immune system by microbes early in life is probably required for an accurate maturation of the immune system. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Allergic Conditions
- What is being tested?
- Lactobacillus reuteri
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 3 sitesSweden
- Study dates
- Feb 2001to May 2010
- Phase
- Phase 2
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women with history of previous or present allergic disease in at least one member of the immediate family (parents or siblings).
- Expected compliance.
- Written informed consent obtained from parents.
Who cannot join
- Insufficient compliance, i.e. a consumption of the study product below half of the expected.
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Pediatric Clinic, Ryhov Hospital
Jönköping
Pediatric Clinic, University Hospital
Linköping, SE 581 85
Pediatric Clinic, Vrinnevi Hospital
Norrköping
About this study
An altered microbial exposure may be partly responsible for the increase of allergic diseases in populations with a western lifestyle. Activation of the immune system by microbes early in life is probably required for an accurate maturation of the immune system. Probiotics, live bacteria which are considered to confer health when ingested, have been suggested to prevent eczema and sensitisation infants.
The aim of this study is to assess the effect of oral supplementation with the probiotic bacterium Lactobacillus reuteri in infancy on the development of allergic disease and sensitisation during the first 2 years of life and to examine mechanisms possibly underlying eventual effects on allergic manifestations.
A follow up was performed at 7 years of age.
Read the detailed description
An altered microbial exposure may be partly responsible for the increase of allergic diseases in populations with a western lifestyle. Activation of the immune system by microbes early in life is probably required for an accurate maturation of the immune system. Probiotics, live bacteria which are considered to confer health when ingested, have been suggested to prevent eczema and sensitisation infants.
The aim of this study is to assess the effect of oral supplementation with the probiotic bacterium Lactobacillus reuteri (L. reuteri) in infancy on the development of allergic disease and sensitisation during the first 2 years of life and to examine mechanisms possibly underlying eventual effects on allergic manifestations. In the study the development of allergic disease will also be related prospectively to immunological, nutritional and environmental factors.
The study is a prospective double-blind placebo-controlled multicenter trial, comprising 232 families with allergic disease. The families are recruited at the antenatal clinic, and the mothers will receive L. reuteri ATCC 55730 (1 x 100 000 000 colony forming units, Biogaia AB, Stockholm, Sweden) or placebo daily from gestational week 36 until delivery. Their babies then will continue with the same study product from birth until 12 months of age and will be followed up for another year. Clinical follow-up will be done at 1, 3, 6,12 and 24 months of age and telephone interviews at 2,4,5, 8, 10 and 18 months. A questionnaire will be completed on each occasion. Skin prick test will be performed at 6, 12 and 24 months of age. Venous blood will be collected from the umbilical cord and at 6, 12 and 24 months and stored as heparinized plasma or serum until assessment. Peripheral mononuclear blood cells (PBMC) will be separated from the plasma samples before storage. Blood samples will also be collected from the mother and father once during the study. The stool sample will be collected from the mother during the 1 week after delivery and the infant at 5-7 days, 1 month, 3 months, 6 months, 12 months and 24 months of age. Saliva samples will be collected at 3, 6, 12 and 24 months of age and breast milk samples will be collected from the mother 1-3 days and 1 months after delivery. The saliva, breast milk and plasma/serum samples will be stored in -20°C and stool samples and the PBMC in -70°C until assessment.
A follow up was performed at 7 years of age focusing on allergic disease. Spirometry, skin prick test was performed. Of the 188 completing the 2 year follow up, 184 also completed the 7 year follow up.
- Conditions
- Allergic Conditions
- Being tested
- Lactobacillus reuteri, Placebo
- Keywords
- Infants, Probiotics, Prevention, Lactobacillus reuteri, Eczema, IgE, Sensitization, Microbiota, Chemokines
- Medical subject headings
- Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteriDietary supplement
The mothers started taking Lactobacillus reuteri ATCC 55730 (BioGaia AB, Stockholm, Sweden) or placebo four weeks before term and continued to do so daily until delivery. After birth, the baby commenced with the same study product as the mother at 1-3 days of age and continued daily for one year. The daily intake, five oil droplets, corresponded to 1 x 100 000 000 colony forming units (CFU)
PlaceboDietary supplement
The placebo consists of the same oil that the active study product but without any bacteria and is not possible to differentiate from the active product by smell, taste or visual appearance
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Lactobacillus reuteri | Active comparator | Not described Receives: Dietary Supplement: Lactobacillus reuteri |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergic disease
Allergic disease was defined as any of the following: eczema, asthma, allergic rhinoconjunctivitis, allergic urticaria, gastrointestinal allergy. These diagnosis are based on predefined criteria.
Measured: Incidence until 2 years of age
Secondary outcomes (8)
Sensitization
Positive skin prick test and /or circulation IgE against allergen in blood
Measured: incidence until 2 years of age
IgE-associated allergic disease
Allergic disease was classified as IgE-associated if the symptomatic infant also was sensitized
Measured: Incidence until 2 years of age
Lactobacillus reuteri colonization in stool and breast milk
Isolation of Lactobacillus reuteri in stool and breast milk samples from the mother and infant with conventional and molecular methods.
Measured: Point prevalance until 2 years of age
Cytokines in breast milk
Cytokines in breast milk from the mother will be measured by ELISA.
Measured: 1-3 days and 1 months postpartum
Th1 and Th2- associated chemokines in blood samples
Th1 and Th2- associated chemokines will be analyzed in blood samples from the infant with ELISA and Luminex.
Measured: Development from birth until 2 years of age
Microbial composition in stool samples
The microbial composition in stoll samples from the mothers and infants will be assessed with conventional cultivation and molecular microbiology methods
Measured: Development from birth until 2 years of age
Allergic disease at 7 years of age
Allergic disease at 7 years of age was defined as any of the following: eczema, asthma, allergic rhinoconjunctivitis, allergic urticaria. These diagnosis are based on predefined criteria.
Measured: 2001-2011
Prevalence of caries in primary dentition at 8 years of age
Prevalence of caries in primary dentition is examined by dentists at 8 yeas of age. These diagnosis are based on predefined criteria.
Measured: 2009-2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study startFeb 2001
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Allergic ConditionsStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- BioGaia AB, The Ekhaga Foundation, Sweden, The Heart and Lung foundation, Sweden, The Research Council for the South-East Sweden, The Swedish Asthma and Allergy Association, Sweden, The Swedish Research Council, University Hospital, Linkoeping
- Investigators
- Bengt Björkstén, MD, PhD, Principal investigator, The National Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285830
- Sponsor's protocol ID
- BGB 99/02
- Other IDs
- F2000-106
- Status last verified
- Jan 2011
- First submitted
- 27 Jan 2011
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Abrahamsson TR, Jakobsson T, Bottcher MF, Fredrikson M, Jenmalm MC, Bjorksten B, Oldaeus G. Probiotics in prevention of IgE-associated eczema: a double-blind, randomized, placebo-controlled trial. J Allergy Clin Immunol. 2007 May;119(5):1174-80. doi: 10.1016/j.jaci.2007.01.007. Epub 2007 Mar 8.
PubMed 17349686Bottcher MF, Abrahamsson TR, Fredriksson M, Jakobsson T, Bjorksten B. Low breast milk TGF-beta2 is induced by Lactobacillus reuteri supplementation and associates with reduced risk of sensitization during infancy. Pediatr Allergy Immunol. 2008 Sep;19(6):497-504. doi: 10.1111/j.1399-3038.2007.00687.x. Epub 2008 Jan 22.
PubMed 18221472Abrahamsson TR, Sinkiewicz G, Jakobsson T, Fredrikson M, Bjorksten B. Probiotic lactobacilli in breast milk and infant stool in relation to oral intake during the first year of life. J Pediatr Gastroenterol Nutr. 2009 Sep;49(3):349-54. doi: 10.1097/MPG.0b013e31818f091b.
PubMed 19525871Connolly E, Abrahamsson T, Bjorksten B. Safety of D(-)-lactic acid producing bacteria in the human infant. J Pediatr Gastroenterol Nutr. 2005 Oct;41(4):489-92. doi: 10.1097/01.mpg.0000176179.81638.45. No abstract available.
PubMed 16205524Abrahamsson TR, Sandberg Abelius M, Forsberg A, Bjorksten B, Jenmalm MC. A Th1/Th2-associated chemokine imbalance during infancy in children developing eczema, wheeze and sensitization. Clin Exp Allergy. 2011 Dec;41(12):1729-39. doi: 10.1111/j.1365-2222.2011.03827.x. Epub 2011 Aug 1.
PubMed 21801246Abrahamsson TR, Jakobsson HE, Andersson AF, Bjorksten B, Engstrand L, Jenmalm MC. Low diversity of the gut microbiota in infants with atopic eczema. J Allergy Clin Immunol. 2012 Feb;129(2):434-40, 440.e1-2. doi: 10.1016/j.jaci.2011.10.025. Epub 2011 Dec 6.
PubMed 22153774Forsberg A, Abrahamsson TR, Bjorksten B, Jenmalm MC. Pre- and post-natal Lactobacillus reuteri supplementation decreases allergen responsiveness in infancy. Clin Exp Allergy. 2013 Apr;43(4):434-42. doi: 10.1111/cea.12082.
PubMed 23517039Jakobsson HE, Abrahamsson TR, Jenmalm MC, Harris K, Quince C, Jernberg C, Bjorksten B, Engstrand L, Andersson AF. Decreased gut microbiota diversity, delayed Bacteroidetes colonisation and reduced Th1 responses in infants delivered by caesarean section. Gut. 2014 Apr;63(4):559-66. doi: 10.1136/gutjnl-2012-303249. Epub 2013 Aug 7.
PubMed 23926244Abrahamsson TR, Jakobsson T, Bjorksten B, Oldaeus G, Jenmalm MC. No effect of probiotics on respiratory allergies: a seven-year follow-up of a randomized controlled trial in infancy. Pediatr Allergy Immunol. 2013 Sep;24(6):556-61. doi: 10.1111/pai.12104. Epub 2013 Jul 31.
PubMed 23902407Abrahamsson TR, Jakobsson HE, Andersson AF, Bjorksten B, Engstrand L, Jenmalm MC. Low gut microbiota diversity in early infancy precedes asthma at school age. Clin Exp Allergy. 2014 Jun;44(6):842-50. doi: 10.1111/cea.12253.
PubMed 24330256Forsberg A, Abrahamsson TR, Bjorksten B, Jenmalm MC. Pre- and postnatal administration of Lactobacillus reuteri decreases TLR2 responses in infants. Clin Transl Allergy. 2014 Jun 25;4:21. doi: 10.1186/2045-7022-4-21. eCollection 2014.
PubMed 25002964Abrahamsson TR, Rautava S, Moore AM, Neu J, Sherman PM. The time for a confirmative necrotizing enterocolitis probiotics prevention trial in the extremely low birth weight infant in North America is now! J Pediatr. 2014 Aug;165(2):389-94. doi: 10.1016/j.jpeds.2014.05.012. Epub 2014 Jun 16. No abstract available.
PubMed 24948349
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Prevention of Allergic Disease in Early Child by Lactobacillus Reuteri
- ClinicalTrials.gov ID
- NCT01285830
- Acronym / sponsor ID
- BGB 99/02
- Conditions
- Allergic Conditions
- Keywords
- Infants, Probiotics, Prevention, Lactobacillus reuteri, Eczema, IgE, Sensitization, Microbiota
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- BioGaia AB, The Ekhaga Foundation, Sweden, The Heart and Lung foundation, Sweden, The Research Council for the South-East Sweden, The Swedish Asthma and Allergy Association, Sweden, The Swedish Research Council, University Hospital, Linkoeping
- Study start
- Feb 2001
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 28 Jan 2011 (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.
An altered microbial exposure may be partly responsible for the increase of allergic diseases in populations with a western lifestyle. Activation of the immune system by microbes early in life is probably required for an accurate maturation of the immune system. Probiotics, live bacteria which are considered to confer health when ingested, have been suggested to prevent eczema and sensitisation infants.
The aim of this study is to assess the effect of oral supplementation with the probiotic bacterium Lactobacillus reuteri in infancy on the development of allergic disease and sensitisation during the first 2 years of life and to examine mechanisms possibly underlying eventual effects on allergic manifestations.
A follow up was performed at 7 years of age.
Detailed description
An altered microbial exposure may be partly responsible for the increase of allergic diseases in populations with a western lifestyle. Activation of the immune system by microbes early in life is probably required for an accurate maturation of the immune system. Probiotics, live bacteria which are considered to confer health when ingested, have been suggested to prevent eczema and sensitisation infants.
The aim of this study is to assess the effect of oral supplementation with the probiotic bacterium Lactobacillus reuteri (L. reuteri) in infancy on the development of allergic disease and sensitisation during the first 2 years of life and to examine mechanisms possibly underlying eventual effects on allergic manifestations. In the study the development of allergic disease will also be related prospectively to immunological, nutritional and environmental factors.
The study is a prospective double-blind placebo-controlled multicenter trial, comprising 232 families with allergic disease. The families are recruited at the antenatal clinic, and the mothers will receive L. reuteri ATCC 55730 (1 x 100 000 000 colony forming units, Biogaia AB, Stockholm, Sweden) or placebo daily from gestational week 36 until delivery. Their babies then will continue with the same study product from birth until 12 months of age and will be followed up for another year. Clinical follow-up will be done at 1, 3, 6,12 and 24 months of age and telephone interviews at 2,4,5, 8, 10 and 18 months. A questionnaire will be completed on each occasion. Skin prick test will be performed at 6, 12 and 24 months of age. Venous blood will be collected from the umbilical cord and at 6, 12 and 24 months and stored as heparinized plasma or serum until assessment. Peripheral mononuclear blood cells (PBMC) will be separated from the plasma samples before storage. Blood samples will also be collected from the mother and father once during the study. The stool sample will be collected from the mother during the 1 week after delivery and the infant at 5-7 days, 1 month, 3 months, 6 months, 12 months and 24 months of age. Saliva samples will be collected at 3, 6, 12 and 24 months of age and breast milk samples will be collected from the mother 1-3 days and 1 months after delivery. The saliva, breast milk and plasma/serum samples will be stored in -20°C and stool samples and the PBMC in -70°C until assessment.
A follow up was performed at 7 years of age focusing on allergic disease. Spirometry, skin prick test was performed. Of the 188 completing the 2 year follow up, 184 also completed the 7 year follow up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Lactobacillus reuteri | Active comparator | Dietary Supplement: Lactobacillus reuteri |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women with history of previous or present allergic disease in at least one member of the immediate family (parents or siblings).
- Expected compliance.
- Written informed consent obtained from parents.
Key exclusion criteria (1 listed)
- Insufficient compliance, i.e. a consumption of the study product below half of the expected.
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 |
|---|---|---|
| Lactobacillus reuteriThe mothers started taking Lactobacillus reuteri ATCC 55730 (BioGaia AB, Stockholm, Sweden) or placebo four weeks before term and continued to do so daily until delivery. After birth, the baby commenced with the same study product as the mother at 1-3 days of age and continued daily for one year. The daily intake, five oil droplets, corresponded to 1 x 100 000 000 colony forming units (CFU) | Dietary supplement | Lactobacillus reuteri |
| PlaceboThe placebo consists of the same oil that the active study product but without any bacteria and is not possible to differentiate from the active product by smell, taste or visual appearance | Dietary supplement | Placebo |
Primary outcome
Allergic disease
Time frame: Incidence until 2 years of age
Allergic disease was defined as any of the following: eczema, asthma, allergic rhinoconjunctivitis, allergic urticaria, gastrointestinal allergy. These diagnosis are based on predefined criteria.
8 secondary outcomes
Sensitization
Time frame: incidence until 2 years of age
IgE-associated allergic disease
Time frame: Incidence until 2 years of age
Lactobacillus reuteri colonization in stool and breast milk
Time frame: Point prevalance until 2 years of age
Cytokines in breast milk
Time frame: 1-3 days and 1 months postpartum
Th1 and Th2- associated chemokines in blood samples
Time frame: Development from birth until 2 years of age
Microbial composition in stool samples
Time frame: Development from birth until 2 years of age
Allergic disease at 7 years of age
Time frame: 2001-2011
Prevalence of caries in primary dentition at 8 years of age
Time frame: 2009-2012
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 20 Mar 2014.
- Results publication: PubMed 17349686Abrahamsson TR, Jakobsson T, Bottcher MF, Fredrikson M, Jenmalm MC, Bjorksten B, Oldaeus G. Probiotics in prevention of IgE-associated eczema: a double-blind, randomized, placebo-controlled trial. J Allergy Clin Immunol. 2007 May;119(5):1174-80. doi: 10.1016/j.jaci.2007.01.007. Epub 2007 Mar 8.
- Results publication: PubMed 18221472Bottcher MF, Abrahamsson TR, Fredriksson M, Jakobsson T, Bjorksten B. Low breast milk TGF-beta2 is induced by Lactobacillus reuteri supplementation and associates with reduced risk of sensitization during infancy. Pediatr Allergy Immunol. 2008 Sep;19(6):497-504. doi: 10.1111/j.1399-3038.2007.00687.x. Epub 2008 Jan 22.
- Results publication: PubMed 19525871Abrahamsson TR, Sinkiewicz G, Jakobsson T, Fredrikson M, Bjorksten B. Probiotic lactobacilli in breast milk and infant stool in relation to oral intake during the first year of life. J Pediatr Gastroenterol Nutr. 2009 Sep;49(3):349-54. doi: 10.1097/MPG.0b013e31818f091b.
- Results publication: PubMed 16205524Connolly E, Abrahamsson T, Bjorksten B. Safety of D(-)-lactic acid producing bacteria in the human infant. J Pediatr Gastroenterol Nutr. 2005 Oct;41(4):489-92. doi: 10.1097/01.mpg.0000176179.81638.45. No abstract available.
- Results publication: PubMed 21801246Abrahamsson TR, Sandberg Abelius M, Forsberg A, Bjorksten B, Jenmalm MC. A Th1/Th2-associated chemokine imbalance during infancy in children developing eczema, wheeze and sensitization. Clin Exp Allergy. 2011 Dec;41(12):1729-39. doi: 10.1111/j.1365-2222.2011.03827.x. Epub 2011 Aug 1.
- Results publication: PubMed 22153774Abrahamsson TR, Jakobsson HE, Andersson AF, Bjorksten B, Engstrand L, Jenmalm MC. Low diversity of the gut microbiota in infants with atopic eczema. J Allergy Clin Immunol. 2012 Feb;129(2):434-40, 440.e1-2. doi: 10.1016/j.jaci.2011.10.025. Epub 2011 Dec 6.
- Results publication: PubMed 23517039Forsberg A, Abrahamsson TR, Bjorksten B, Jenmalm MC. Pre- and post-natal Lactobacillus reuteri supplementation decreases allergen responsiveness in infancy. Clin Exp Allergy. 2013 Apr;43(4):434-42. doi: 10.1111/cea.12082.
- Results publication: PubMed 23926244Jakobsson HE, Abrahamsson TR, Jenmalm MC, Harris K, Quince C, Jernberg C, Bjorksten B, Engstrand L, Andersson AF. Decreased gut microbiota diversity, delayed Bacteroidetes colonisation and reduced Th1 responses in infants delivered by caesarean section. Gut. 2014 Apr;63(4):559-66. doi: 10.1136/gutjnl-2012-303249. Epub 2013 Aug 7.
- Results publication: PubMed 23902407Abrahamsson TR, Jakobsson T, Bjorksten B, Oldaeus G, Jenmalm MC. No effect of probiotics on respiratory allergies: a seven-year follow-up of a randomized controlled trial in infancy. Pediatr Allergy Immunol. 2013 Sep;24(6):556-61. doi: 10.1111/pai.12104. Epub 2013 Jul 31.
- Results publication: PubMed 24330256Abrahamsson TR, Jakobsson HE, Andersson AF, Bjorksten B, Engstrand L, Jenmalm MC. Low gut microbiota diversity in early infancy precedes asthma at school age. Clin Exp Allergy. 2014 Jun;44(6):842-50. doi: 10.1111/cea.12253.
- Derived from this study: PubMed 25002964Forsberg A, Abrahamsson TR, Bjorksten B, Jenmalm MC. Pre- and postnatal administration of Lactobacillus reuteri decreases TLR2 responses in infants. Clin Transl Allergy. 2014 Jun 25;4:21. doi: 10.1186/2045-7022-4-21. eCollection 2014.
- Derived from this study: PubMed 24948349Abrahamsson TR, Rautava S, Moore AM, Neu J, Sherman PM. The time for a confirmative necrotizing enterocolitis probiotics prevention trial in the extremely low birth weight infant in North America is now! J Pediatr. 2014 Aug;165(2):389-94. doi: 10.1016/j.jpeds.2014.05.012. Epub 2014 Jun 16. No abstract available.
Related trials for Allergic Conditions
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Active, not recruitingObservational study
Guangzhou Preterm and Term Birth Cohort Study
Preterm Birth, Neurodevelopmental Disorders
Not yet recruitingPhase 4
Gabapentin vs. Benzonatate vs. Standard of Care for Cough in ILD
Interstitial Lung Disease
RecruitingPhase 3
A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis
Eosinophilic Esophagitis (EoE)
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.
Bengt Björkstén, MD, PhD principal investigator
The National Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lactobacillus reuteri in people with Allergic Conditions, run by Linkoeping University at 3 sites 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 3 inclusion and 1 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 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Allergic disease (time frame: Incidence until 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 NCT01285830, which also lists 12 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 20 Mar 2014.