Gut MicrobiotaPhase 4NCT01148667
Lactobacillus Rhamnosus GG: Interaction With Human Microbiota and Immunity
A Phase 4 study testing Casein hydrolysate added with LGG and Infants drink casein hydrolysate without LGG in people with Gut Microbiota and Skin Microbiota, run by Turku University Hospital at 1 site in Finland.
Trial summary
Hypothesis: Probiotics have been used as novel adjunct therapeutic approach in atopic dermatitis. In addition to balancing the gut microecology and promoting host immune defences, specific probiotics might further aid in controlling the microbial colonization of the skin, thereby reducing proneness to secondary… Read more about this study
- Who is it for?
- Ages 4 weeks to 18 months
- Conditions the study is for
- Gut Microbiota, Skin Microbiota, Humoral Immune Responses
- What is being tested?
- Casein hydrolysate added with LGG and Infants drink casein hydrolysate without LGG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2007to Jul 2008
- Phase
- Phase 4
- 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 weeks to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- clinical diagnosis of atopic dermatitis
- age 4 we - 18 mo
Who cannot join
- skin infection or severe infection at the time of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interaction of Orally Administered Lactobacillus Rhamnosus GG With Skin and Gut Microbiota and Humoral Immunity in Infants With Atopic Dermatitis
Hypothesis: Probiotics have been used as novel adjunct therapeutic approach in atopic dermatitis. In addition to balancing the gut microecology and promoting host immune defences, specific probiotics might further aid in controlling the microbial colonization of the skin, thereby reducing proneness to secondary infections which typically cause sustained symptoms.
Thirty-nine infants with atopic dermatitis,randomized for a three-month-period in a double-blind design to receive extensively hydrolysed casein formula (NutramigenR, Mead-Johnson, USA) supplemented with (n=19) or without (n=20) Lactobacillus rhamnosus GG (ATCC 53103) 5.0 x 107 cfu/g to achieve a daily intake of 3.4 x 109 cfu.
Sampling (blood and faecal samples, cotton swab from the skin) and clinical examination of the infant, including SCORAD assessment to determine the severity of atopic dermatitis, at each study visit (at entry and one month and three months thereafter).
- Being tested
- Casein hydrolysate added with LGG, Infants drink casein hydrolysate without LGG
- Keywords
- atopic dermatitis, barrier function, gut, probiotics, skin
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Casein hydrolysate added with LGGDietary supplement
Infants drink extensively hydrolysed casein formula supplemented with LGG (ATCC 53103) 5.0 x 10 7 cfu/g to achieve a daily intake of 3.4 10 9 cfu.
Infants drink casein hydrolysate without LGGDietary supplement
Infants drink extensively hydrolysed casein formula without added LGG
| Study group | Role | What they receive |
|---|---|---|
| Infants drink formula added with LGG | Active comparator | Infants have been randomized (1:1) to get casein hydrolysate with or without LGG Receives: Dietary Supplement: Casein hydrolysate added with LGG |
| Infants drink casein hydrolysate without LGG | Placebo comparator | Infants get extensively hydrolysed casein formula Receives: Dietary Supplement: Infants drink casein hydrolysate without LGG |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of atopic dermatitis
Severity of atopic dermatitis of the study infants will be assessed by SCORAD index
Measured: March 2007 - July 2008
Secondary outcomes (1)
Maturation of humoral immune responses
Determination of proportions of immunoglobulin secreting cells among peripheral blood mononuclear cells was carried out by ELISPOT assay. The proportions of CD 19+ memory B cells was carried out by flow cytometry
Measured: March 2007 - July 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startMar 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gut MicrobiotaStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Academy of Finland, Mead Johnson Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148667
- Sponsor's protocol ID
- 12/2006 1 531
- Status last verified
- Jun 2010
- First submitted
- 21 Jun 2010
- Last updated
- 22 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Nermes M, Kantele JM, Atosuo TJ, Salminen S, Isolauri E. Interaction of orally administered Lactobacillus rhamnosus GG with skin and gut microbiota and humoral immunity in infants with atopic dermatitis. Clin Exp Allergy. 2011 Mar;41(3):370-7. doi: 10.1111/j.1365-2222.2010.03657.x. Epub 2010 Dec 1.
PubMed 21121981
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction of Orally Administered Lactobacillus Rhamnosus GG With Skin and Gut Microbiota and Humoral Immunity in Infants With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01148667
- Acronym / sponsor ID
- 12/2006 1 531
- Keywords
- atopic dermatitis, barrier function, gut, probiotics, skin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Academy of Finland, Mead Johnson Nutrition
- Study start
- Mar 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 22 Jun 2010 (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.
Hypothesis: Probiotics have been used as novel adjunct therapeutic approach in atopic dermatitis. In addition to balancing the gut microecology and promoting host immune defences, specific probiotics might further aid in controlling the microbial colonization of the skin, thereby reducing proneness to secondary infections which typically cause sustained symptoms.
Thirty-nine infants with atopic dermatitis,randomized for a three-month-period in a double-blind design to receive extensively hydrolysed casein formula (NutramigenR, Mead-Johnson, USA) supplemented with (n=19) or without (n=20) Lactobacillus rhamnosus GG (ATCC 53103) 5.0 x 107 cfu/g to achieve a daily intake of 3.4 x 109 cfu.
Sampling (blood and faecal samples, cotton swab from the skin) and clinical examination of the infant, including SCORAD assessment to determine the severity of atopic dermatitis, at each study visit (at entry and one month and three months thereafter).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants drink formula added with LGG | Active comparator | Dietary Supplement: Casein hydrolysate added with LGGInfants have been randomized (1:1) to get casein hydrolysate with or without LGG |
| Infants drink casein hydrolysate without LGG | Placebo comparator | Dietary Supplement: Infants drink casein hydrolysate without LGGInfants get extensively hydrolysed casein formula |
Who may qualify
- Ages
- 4 weeks to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- clinical diagnosis of atopic dermatitis
- age 4 we - 18 mo
Key exclusion criteria (1 listed)
- skin infection or severe infection at the time of enrollment
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 |
|---|---|---|
| Casein hydrolysate added with LGGInfants drink extensively hydrolysed casein formula supplemented with LGG (ATCC 53103) 5.0 x 10 7 cfu/g to achieve a daily intake of 3.4 10 9 cfu. | Dietary supplement | Infants drink formula added with LGG |
| Infants drink casein hydrolysate without LGGInfants drink extensively hydrolysed casein formula without added LGG | Dietary supplement | Infants drink casein hydrolysate without LGG |
Primary outcome
severity of atopic dermatitis
Time frame: March 2007 - July 2008
Severity of atopic dermatitis of the study infants will be assessed by SCORAD index
1 secondary outcome
Maturation of humoral immune responses
Time frame: March 2007 - July 2008
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 22 Jun 2010.
- Derived from this study: PubMed 21121981Nermes M, Kantele JM, Atosuo TJ, Salminen S, Isolauri E. Interaction of orally administered Lactobacillus rhamnosus GG with skin and gut microbiota and humoral immunity in infants with atopic dermatitis. Clin Exp Allergy. 2011 Mar;41(3):370-7. doi: 10.1111/j.1365-2222.2010.03657.x. Epub 2010 Dec 1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Casein hydrolysate added with LGG and Infants drink casein hydrolysate without LGG in people with Gut Microbiota and Skin Microbiota, run by Turku University Hospital at 1 site in Finland.
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 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 22 Jun 2010. 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 Finland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
severity of atopic dermatitis (time frame: March 2007 - July 2008). 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 NCT01148667, which also lists 1 linked publication.
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 22 Jun 2010; AzTrials last refreshed its copy on 6 Nov 2026.