EczemaELEFANTNCT00894816
Probiotics in Prevention of Allergies, Obesity and Caries
A study testing Lactobacillus F19 in people with Eczema and Allergy, run by Umeå University at 1 site in Sweden.
Trial summary
During the period of 2000-2003, 179 healthy, term infants with no previous signs of allergic disease were recruited and randomized to daily intake of cereals with or without the addition of Lactobacillus paracasei subspecies paracasei strain F19 (LF19) from 4-13 months of age. Read more about this study
- Who is it for?
- Ages 4 to 4 monthsHealthy volunteers can take part
- What is being tested?
- Lactobacillus F19
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2000to Nov 2020
- 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 4 to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants born at term (gestational age 37-42 weeks)
- Birth weight > 2500 g
- Vaginally delivered
- No atopic manifestation
- A normal diet for age
- No medication that could have affected the intestinal microbiota
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Feeding Lactobacillus F19 to Infants During Weaning on Allergies, Immune Programming, Gut Microbiota, Overweight and Oral Health
During the period of 2000-2003, 179 healthy, term infants with no previous signs of allergic disease were recruited and randomized to daily intake of cereals with or without the addition of Lactobacillus paracasei subspecies paracasei strain F19 (LF19) from 4-13 months of age. The effects of LF19 on gut microbial composition, infections, allergies, immunological development, growth and blood lipids were monitored. Of 179 included infants, 171 completed the study. The study product was well tolerated with no observed side effects. Compliance was excellent.
In a follow-up study, the aim is to investigate the long-term effects of feeding LF19 during weaning on allergies, immune programming, overweight, gut microbial composition and oral health in 8-year old children.
The investigators' primary outcome will be to determine whether daily intake of LF19 during weaning results in less eczema at 8 years of age, and if the preventive effect encompasses also respiratory allergies and immunoglobulin E (IgE) - sensitization. The long term effects on gut microbial composition, overweight and metabolic markers will be investigated. Furthermore, the possible preventive effects of LF19 on caries will be assessed.
- Conditions
- Eczema, Allergy, Asthma, Obesity, Dental Caries
- Being tested
- Lactobacillus F19, Placebo
- Keywords
- Prevention, Probiotics, Eczema, Allergy, Asthma, Obesity, Caries, Gut microbiota
- Medical subject headings
- Eczema, Hypersensitivity, Asthma, Obesity, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus F19Dietary supplement
Infant cereals with the addition of Lactobacillus paracasei subsp. paracasei strain F19 (LF19)10E8 CFU per serving
PlaceboDietary supplement
Infant cereals without any addition
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Infant cereals with the addition of Lactobacillus paracasei subsp. paracasei strain F19 (LF19) 10E8 CFU per serving Receives: Dietary Supplement: Lactobacillus F19 |
| 2 | Placebo comparator | Placebo (infant cereals without any additions) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eczema
Eczema including related allergic manifestations
Measured: 8 years of age
Secondary outcomes (5)
Respiratory allergies
Allergic rhinitis and asthma
Measured: 8 years of age
Sensitization
Assessed by skin prick test and specific IgE tests
Measured: 8 years of age
Overweight/obesity
Assessed by BMI and DEXA-scan
Measured: 8 years of age
Gut microbial composition
Assessed by Molecular biology techniques
Measured: 8 years of age
Caries
Clinical evaluation and x-ray
Measured: 8 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startAug 2000
- Primary completionSep 2011
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for EczemaStudies of the same condition, open and under way.
- More trials run by Umeå 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, University of Helsinki, The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS), Medical Research Council, Ekhagastiftelsen, The county of Västerbotten, Oskar Foundation
- Responsible party
- Principal investigator, Christina West, Umeå University
- Investigators
- Christina E West, MD, PhD, Principal investigator, Clinical Sciences, Pediatrics, Umeå University, SE-901 87 Umeå, SwedenOlle Hernell, Professor, Study chair, Clinical Sciences, Pediatrics, Umeå University, SE-901 87 Umeå, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894816
- Sponsor's protocol ID
- ELEFANT
- Acronym
- ELEFANT
- Status last verified
- Apr 2021
- First submitted
- 6 May 2009
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Karlsson Videhult F, Ohlund I, Stenlund H, Hernell O, West CE. Probiotics during weaning: a follow-up study on effects on body composition and metabolic markers at school age. Eur J Nutr. 2015 Apr;54(3):355-63. doi: 10.1007/s00394-014-0715-y. Epub 2014 May 17.
PubMed 24830782West CE, Gothefors L, Granstrom M, Kayhty H, Hammarstrom ML, Hernell O. Effects of feeding probiotics during weaning on infections and antibody responses to diphtheria, tetanus and Hib vaccines. Pediatr Allergy Immunol. 2008 Feb;19(1):53-60. doi: 10.1111/j.1399-3038.2007.00583.x. Epub 2007 Dec 11.
PubMed 18086218West CE, Hammarstrom ML, Hernell O. Probiotics during weaning reduce the incidence of eczema. Pediatr Allergy Immunol. 2009 Aug;20(5):430-7. doi: 10.1111/j.1399-3038.2009.00745.x. Epub 2009 Mar 9.
PubMed 19298231West CE, Hernell O, Andersson Y, Sjostedt M, Hammarstrom ML. Probiotic effects on T-cell maturation in infants during weaning. Clin Exp Allergy. 2012 Apr;42(4):540-9. doi: 10.1111/j.1365-2222.2011.03941.x.
PubMed 22417212West CE, Hammarstrom ML, Hernell O. Probiotics in primary prevention of allergic disease--follow-up at 8-9 years of age. Allergy. 2013 Aug;68(8):1015-20. doi: 10.1111/all.12191. Epub 2013 Jul 30.
PubMed 23895631Hasslof P, West CE, Videhult FK, Brandelius C, Stecksen-Blicks C. Early intervention with probiotic Lactobacillus paracasei F19 has no long-term effect on caries experience. Caries Res. 2013;47(6):559-65. doi: 10.1159/000350524. Epub 2013 Jul 4.
PubMed 23838478
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Feeding Lactobacillus F19 to Infants During Weaning on Allergies, Immune Programming, Gut Microbiota, Overweight and Oral Health
- ClinicalTrials.gov ID
- NCT00894816
- Acronym / sponsor ID
- ELEFANT / ELEFANT
- Conditions
- Eczema, Allergy, Asthma, Obesity, Dental Caries
- Keywords
- Prevention, Probiotics, Eczema, Allergy, Asthma, Obesity, Caries, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet, University of Helsinki, The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS), Medical Research Council, Ekhagastiftelsen, The county of Västerbotten, Oskar Foundation
- Study start
- Aug 2000
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 7 May 2009 (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.
During the period of 2000-2003, 179 healthy, term infants with no previous signs of allergic disease were recruited and randomized to daily intake of cereals with or without the addition of Lactobacillus paracasei subspecies paracasei strain F19 (LF19) from 4-13 months of age. The effects of LF19 on gut microbial composition, infections, allergies, immunological development, growth and blood lipids were monitored. Of 179 included infants, 171 completed the study. The study product was well tolerated with no observed side effects. Compliance was excellent.
In a follow-up study, the aim is to investigate the long-term effects of feeding LF19 during weaning on allergies, immune programming, overweight, gut microbial composition and oral health in 8-year old children.
The investigators' primary outcome will be to determine whether daily intake of LF19 during weaning results in less eczema at 8 years of age, and if the preventive effect encompasses also respiratory allergies and immunoglobulin E (IgE) - sensitization. The long term effects on gut microbial composition, overweight and metabolic markers will be investigated. Furthermore, the possible preventive effects of LF19 on caries will be assessed.
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 |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Lactobacillus F19Infant cereals with the addition of Lactobacillus paracasei subsp. paracasei strain F19 (LF19) 10E8 CFU per serving |
| 2 | Placebo comparator | Dietary Supplement: PlaceboPlacebo (infant cereals without any additions) |
Who may qualify
- Ages
- 4 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy infants born at term (gestational age 37-42 weeks)
- Birth weight > 2500 g
- Vaginally delivered
- No atopic manifestation
- A normal diet for age
Key exclusion criteria (0 listed)
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 F19Infant cereals with the addition of Lactobacillus paracasei subsp. paracasei strain F19 (LF19)10E8 CFU per serving | Dietary supplement | 1 |
| PlaceboInfant cereals without any addition | Dietary supplement | 2 |
Primary outcome
Eczema
Time frame: 8 years of age
Eczema including related allergic manifestations
5 secondary outcomes
Respiratory allergies
Time frame: 8 years of age
Sensitization
Time frame: 8 years of age
Overweight/obesity
Time frame: 8 years of age
Gut microbial composition
Time frame: 8 years of age
Caries
Time frame: 8 years of age
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 28 Apr 2021.
- Background: PubMed 24830782Karlsson Videhult F, Ohlund I, Stenlund H, Hernell O, West CE. Probiotics during weaning: a follow-up study on effects on body composition and metabolic markers at school age. Eur J Nutr. 2015 Apr;54(3):355-63. doi: 10.1007/s00394-014-0715-y. Epub 2014 May 17.
- Results publication: PubMed 18086218West CE, Gothefors L, Granstrom M, Kayhty H, Hammarstrom ML, Hernell O. Effects of feeding probiotics during weaning on infections and antibody responses to diphtheria, tetanus and Hib vaccines. Pediatr Allergy Immunol. 2008 Feb;19(1):53-60. doi: 10.1111/j.1399-3038.2007.00583.x. Epub 2007 Dec 11.
- Results publication: PubMed 19298231West CE, Hammarstrom ML, Hernell O. Probiotics during weaning reduce the incidence of eczema. Pediatr Allergy Immunol. 2009 Aug;20(5):430-7. doi: 10.1111/j.1399-3038.2009.00745.x. Epub 2009 Mar 9.
- Results publication: PubMed 22417212West CE, Hernell O, Andersson Y, Sjostedt M, Hammarstrom ML. Probiotic effects on T-cell maturation in infants during weaning. Clin Exp Allergy. 2012 Apr;42(4):540-9. doi: 10.1111/j.1365-2222.2011.03941.x.
- Results publication: PubMed 23895631West CE, Hammarstrom ML, Hernell O. Probiotics in primary prevention of allergic disease--follow-up at 8-9 years of age. Allergy. 2013 Aug;68(8):1015-20. doi: 10.1111/all.12191. Epub 2013 Jul 30.
- Results publication: PubMed 23838478Hasslof P, West CE, Videhult FK, Brandelius C, Stecksen-Blicks C. Early intervention with probiotic Lactobacillus paracasei F19 has no long-term effect on caries experience. Caries Res. 2013;47(6):559-65. doi: 10.1159/000350524. Epub 2013 Jul 4.
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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.
Christina E West, MD, PhD principal investigator
Clinical Sciences, Pediatrics, Umeå University, SE-901 87 Umeå, Sweden
Olle Hernell, Professor study chair
Clinical Sciences, Pediatrics, Umeå University, SE-901 87 Umeå, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus F19 in people with Eczema and Allergy, run by Umeå University 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 6 inclusion and 0 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 28 Apr 2021. 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?
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?
Eczema (time frame: 8 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 NCT00894816, which also lists 6 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 28 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.