Atopic DermatitisNCT02103972
Assessment of Efficacy of the Consumption of a Heat-treated Lactobacillus Paracasei (GM080) on Atopic Dermatitis
A study testing GM080 and Maltodextrin in people with Atopic Dermatitis, run by Société des Produits Nestlé (SPN) at 6 sites in Taiwan.
Trial summary
The primary objective of this trial is to assess the efficacy of the consumption of heat-treated Lactobacillus paracasei (GM080) on atopic dermatitis as compared to a placebo treatment. Read more about this study
- Who is it for?
- Ages 4 to 30 monthsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- GM080 and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 6 sitesTaiwan
- Study dates
- Jul 2014to Nov 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 4 to 30 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants aged from 4-30 months (inclusive) at the time of enrolment (63 in each group).
- With mild to severe atopic symptoms: SCORAD ≥ 20 (at V0b).
- Having obtained his/her (or his/her legal representative's) written Informed Consent.
Who cannot join
- SCORAD inferior to 20 (SCORAD less than 20 at V0b). A SCORAD less than 20 at V0c is not an exclusion criteria.
- Infants who need a systemic treatment for their skin condition (e.g. glucocorticoids, steroids, cyclosporine A).
- Infants or mothers who introduce probiotics (other than the study product) in their diet during the 16-weeks intervention study. Of note: Infants or mothers who are used to consume a certain probiotic for more than 1 month before the start of the study (V0b), can continue to use this probiotic during the intervention period and will not be excluded. Recent introduction of probiotics, within a month before the planned start of the study (V0b) should be stopped and recorded; at least 1 month should be between stopping the consumption of the probiotic and V0b).
- Infants having other inflammatory skin diseases (urticaria, psoriasis).
- Infants having a congenital illness or malformation that may affect normal growth (especially immunodeficiency).
- Infants whose parents/caregivers cannot be expected to comply with the study procedures.
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- Infants currently participating or having participated in another clinical study during the last 4 weeks prior to the beginning of this study.
- Infants using topical calcineurin inhibitors (e.g. tacrolimus and pimecrolimus (ELIDEL®)) during the study.
- Infants who have undergone in the month before the start of the study (V0b), are currently undergoing or are anticipated to undergo ultraviolet light therapy or wet dressing or any other topical treatment of their eczema other than the one provided in the study. Lotion and skin moisturizer are allowed but need to be monitored for frequency and area.
- The investigator and clinician will assess if the child has to be excluded based on the patient's medical condition and taken into account the values of the safety parameters tested. Therefore, no cut-off values, or normal ranges for the different safety parameters are exclusion criteria. It will be the responsibility of the investigator and clinician, based on their medical judgement, to decide if it is safe or not to include an infant into the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Linkou Chang Gung Memorial Hospital
Gueishan Township, Taoyuan County, 333
Kaohsiung Municipal TA-TUNG Hospital
Kaohsiung City, Qianjin District, 801
Kaohsiung Municipal Hsiao-Kang Hospital
Kaohsiung City, Siaogang District, 812
Cardinal Tien Hospital
New Taipei City, Xindian District, 231
Chung Shan Medical University Hospital
Taichung, South District, 402
Taipei Chang Gung Memorial Hospital of the Chang-Gung Medical foundation
Taipei, Songshan District, 105
About this study
The primary objective of this trial is to assess the efficacy of the consumption of heat-treated Lactobacillus paracasei (GM080) on atopic dermatitis as compared to a placebo treatment.
- Conditions
- Atopic Dermatitis
- Being tested
- GM080, Maltodextrin
- Keywords
- All subjects of any ethnicity aged from 4 to 30 months with atopic dermatitis skin symptoms with a SCORAD equal or above 20
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM080Dietary supplement
MaltodextrinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Maltodextrin | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Maltodextrin |
| GM080 | Active comparator | GM080 Receives: Dietary Supplement: GM080 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline SCORAD Score at 16 weeks of treatment
SCORAD documented during the longitudinal observational period of 16 weeks after the subject has enrolled
Measured: between 0 and 16 weeks of treatment
Secondary outcomes (8)
Score A, B and C of the SCORAD
Score A, B and C of the SCORAD The scores A, B and C of the SCORAD as well as the subcategories of the scores B and C will be analyzed separately (measured at V0c, V1, V2 and V3)
Measured: 0, 4, 10 and 16 weeks of treatment
Number and duration of atopic dermatitis episodes
Number and duration of atopic dermatitis episodes The number of episodes of atopic dermatitis and the total number of days with symptoms during the 16 weeks intervention period
Measured: during the 16 weeks intervention period
Transepidermal water loss
TEWL will be measured at V0, V1, V2 and V3 on 4 sites of both non-lesional and lesional appearing skin parts
Measured: 0, 4, 10 and 16 weeks
Topical treatment used
Topical treatment used (sparing effect) The corticoid sparing effect of the ingredient will be assessed in the placebo and the ingredient group.
Measured: during the 16 weeks of treatment
total and specific IgE
total and specific IgE
Measured: 0 and 16 weeks
Quality of Life
The infants' dermatitis quality of life index (IDQOL) will be collected
Measured: 0, 4, 10, 16 weeks and 1 and 4 years later
assess the effect of the product on the safety parameters
Biochemistry and Hematology parameters
Measured: 0 and 16 weeks
"Objective" SCORAD, which is composed of part A and B of the SCORAD (measured at V0, V1, V2 and V3)
Measured: 0, 4, 10 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103972
- Sponsor's protocol ID
- 11.46.NRC
- Status last verified
- Jan 2018
- First submitted
- 26 Mar 2014
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy of the Consumption of a Heat-treated Lactobacillus Paracasei (GM080) on Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02103972
- Acronym / sponsor ID
- 11.46.NRC
- Conditions
- Atopic Dermatitis
- Keywords
- All subjects of any ethnicity aged from 4 to 30 months with atopic dermatitis skin symptoms with a SCORAD equal or above 20
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Jul 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 4 Apr 2014 (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.
The primary objective of this trial is to assess the efficacy of the consumption of heat-treated Lactobacillus paracasei (GM080) on atopic dermatitis as compared to a placebo treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maltodextrin | Placebo comparator | Dietary Supplement: MaltodextrinMaltodextrin |
| GM080 | Active comparator | Dietary Supplement: GM080GM080 |
Who may qualify
- Ages
- 4 to 30 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants aged from 4-30 months (inclusive) at the time of enrolment (63 in each group).
- With mild to severe atopic symptoms: SCORAD ≥ 20 (at V0b).
- Having obtained his/her (or his/her legal representative's) written Informed Consent.
Key exclusion criteria (10 listed)
- SCORAD inferior to 20 (SCORAD less than 20 at V0b). A SCORAD less than 20 at V0c is not an exclusion criteria.
- Infants who need a systemic treatment for their skin condition (e.g. glucocorticoids, steroids, cyclosporine A).
- Infants or mothers who introduce probiotics (other than the study product) in their diet during the 16-weeks intervention study. Of note: Infants or mothers who are used to consume a certain probiotic for more than 1 month before the start of the study (V0b), can continue to use this probiotic during the intervention period and will not be excluded. Recent introduction of probiotics, within a month before the planned start of the study (V0b) should be stopped and recorded; at least 1 month should be between stopping the consumption of the probiotic and V0b).
- Infants having other inflammatory skin diseases (urticaria, psoriasis).
- Infants having a congenital illness or malformation that may affect normal growth (especially immunodeficiency).
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 |
|---|---|---|
| GM080 | Dietary supplement | GM080 |
| Maltodextrin | Dietary supplement | Maltodextrin |
Primary outcome
Change from Baseline SCORAD Score at 16 weeks of treatment
Time frame: between 0 and 16 weeks of treatment
SCORAD documented during the longitudinal observational period of 16 weeks after the subject has enrolled
8 secondary outcomes
Score A, B and C of the SCORAD
Time frame: 0, 4, 10 and 16 weeks of treatment
Number and duration of atopic dermatitis episodes
Time frame: during the 16 weeks intervention period
Transepidermal water loss
Time frame: 0, 4, 10 and 16 weeks
Topical treatment used
Time frame: during the 16 weeks of treatment
total and specific IgE
Time frame: 0 and 16 weeks
Quality of Life
Time frame: 0, 4, 10, 16 weeks and 1 and 4 years later
assess the effect of the product on the safety parameters
Time frame: 0 and 16 weeks
"Objective" SCORAD, which is composed of part A and B of the SCORAD (measured at V0, V1, V2 and V3)
Time frame: 0, 4, 10 and 16 weeks
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 26 Jan 2018.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GM080 and Maltodextrin in people with Atopic Dermatitis, run by Société des Produits Nestlé (SPN) at 6 sites in Taiwan.
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 10 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 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan. 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?
Change from Baseline SCORAD Score at 16 weeks of treatment (time frame: between 0 and 16 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2018.