Atopic DermatitisADreuteriNCT04265716
Topical L. Reuteri in Children With Atopic Dermatitis
A study testing Topical L. reeuteri in people with Atopic Dermatitis, run by Innovacion y Desarrollo de Estrategias en Salud at 1 site in Mexico.
Trial summary
This study evaluates the safety and efficacy of the probiotic L. reuteri vs control product as an adjuvant for improving the skin appearance of children with mild or moderate atopic dermatitis. All children will receive the standard of care. Half of the children will receive topical L. Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Topical L. reeuteri
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteMexico
- Study dates
- 13 Feb 2020to 30 Oct 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 1 year to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children age 1 to 8 years old
- Atopic Dermatitis (AD) according to the criteria of Hanifin and Rajka
- SCORAD Index 15 to 50, inclusive
- Subjects whose parents or legal representative are willing to sign the informed consent
- When the child is 8, he/she must also give consent to participate in the study
Who cannot join
- Use of phototherapy for atopic dermatitis
- Systemic or topic corticosteroids in tthe 30 days prior to the study
- Immunosuppressive or cytostatic drugs in the 2 months prior to the study
- Use of probiotics in the 2 weeks prior to the study
- Other allergic severe disease (asthma, allergic rhinitis)
- Systemic antibiotics in the four days prior to the study
Show all 11Show fewer
- Fever (temperature> 37.5 °C axillary or equivalent)
- Pathologies associated with immunodeficiency or cancer processes
- Dermatological diseases that may hinder the evaluation of atopic dermatitis or require the continued use of topical corticosteroids
- Subjects for whom any of the studies products are contraindicated according to their technical specifications
- Subjects who have participated in research studies with any products in the 3 months prior to the trial
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital General Dr. Manuel Gea Gonzalez
Mexico City, 14080
Pedro Gutierrez-Castrellon, MD, PhD, +525540003000 ext. 1246, inpcochrane@gmail.com
Paola Juarez Valdez, +525540003000 ext. 1246, pao_8816@hotmail.com
About this study
Official title: Topical Lactobacillus Reuteri DSM 17938 to Evaluate Safety and Efficacy on Children With Mild or Moderate Atopic Dermatitis
This study evaluates the safety and efficacy of the probiotic L. reuteri vs control product as an adjuvant for improving the skin appearance of children with mild or moderate atopic dermatitis. All children will receive the standard of care. Half of the children will receive topical L. reuteri in emollient, while the other half will receive the standard of care plus control product
Read the detailed description
AD if a very frequent allergic skin disorders in children. Produce a negative significant impact on quality of life and related costs. Recently the changes of skin microbiota had been related with inadequate evolution of atopic dermatitis.
- reuteri had been identified with some effect to reduce skin inflammation and help to modulate inflammatory pathways on skin. Investigators expect using topical L. reuteri as adjuvant some improvement on skin appearance due to the mode of action previous referenced additionally to some potential changes on microbiome
- Conditions
- Atopic Dermatitis
- Being tested
- Topical L. reeuteri
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical L. reeuteriOther
Tubes with ointment containing L. reuteri DSM17938
| Study group | Role | What they receive |
|---|---|---|
| L. reuteri | Active comparator | Topical administration of ointment with L. reuteri DSM17938, rubbed into skin twice per day Receives: Other: Topical L. reeuteri |
| Placebo | Placebo comparator | Rubbed into skin twice per day Receives: Other: Topical L. reeuteri |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin appearance modification
To evaluate the use of a topical emolient containing L. reuteri DSM17938, in terms of its effect on appearance and symptomology in children with mild to moderate atopic dermatitis evaluated by SCORAD test
Measured: 16 weeks
Secondary outcomes (5)
Frequency of adverse events
To evaluate the frequency of adverse events after the use of topical L. reuteri DSM17938
Measured: 16 weeks
Changes on Quality of life
To evaluate the changes in quality of life after the use of topical L. reuteri DSM17938, evaluated by Children's Dermatology Life Quality Index Score
Measured: 16 weeks
Changes on Family Quality of life: Familys Dermatology Life Quality Index Score
To evaluate the changes in quality of life after the use of topical L. reuteri DSM17938, evaluated by Familys Dermatology Life Quality Index Score.
Measured: 16 weeks
Frecuency of rescue medications
To evaluate the improvement on AD control after the use of topical L. reuteri DSM17938 by frequency of rescue medications
Measured: 16 weeks
Changes on Skin microbiota
To evaluate the skin microbiome after the use of topical L. reuteri through genomic analysis.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start13 Feb 2020
- Primary completion13 May 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double blind, placebo controlled trial, 2 parallel arms. Children with mild or moderate atopic dermatitis will be randomly selected at the Pediatric Dermatologic Clinic-Hospital General GEA-Mexico if they fulfill selectioncriteria.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovacion y Desarrollo de Estrategias en Salud
- Sponsor type
- University, hospital or other
- Collaborators
- BioGaia AB
- Responsible party
- Principal investigator, Pedro Gutierrez Castrellon, Innovacion y Desarrollo de Estrategias en Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265716
- Sponsor's protocol ID
- CSUB0174
- Acronym
- ADreuteri
- Status last verified
- Mar 2020
- First submitted
- 9 Feb 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amalia N, Orchard D, Francis KL, King E. Systematic review and meta-analysis on the use of probiotic supplementation in pregnant mother, breastfeeding mother and infant for the prevention of atopic dermatitis in children. Australas J Dermatol. 2020 May;61(2):e158-e173. doi: 10.1111/ajd.13186. Epub 2019 Nov 12.
PubMed 31721162Yang W, Tu R, Hu Y, He T, Zhang W, Gu L, Liu H. Probiotics supplement for the prevention of eczema in children: Study protocol for a meta-analysis and systematic review. Medicine (Baltimore). 2019 Aug;98(34):e16957. doi: 10.1097/MD.0000000000016957.
PubMed 31441896Yan DC, Hung CH, Sy LB, Lue KH, Shih IH, Yang CY, Chen LC, Sun HL, Lee MS, Chambard J, Tanguy J, Hughes-Formella B, Nutten S, Blanchard C. A Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Oral Administration of a Heat-Treated Lactobacillus paracasei Supplement in Infants with Atopic Dermatitis Receiving Topical Corticosteroid Therapy. Skin Pharmacol Physiol. 2019;32(4):201-211. doi: 10.1159/000499436. Epub 2019 May 22.
PubMed 31117100Li L, Han Z, Niu X, Zhang G, Jia Y, Zhang S, He C. Probiotic Supplementation for Prevention of Atopic Dermatitis in Infants and Children: A Systematic Review and Meta-analysis. Am J Clin Dermatol. 2019 Jun;20(3):367-377. doi: 10.1007/s40257-018-0404-3.
PubMed 30465329Navarro-Lopez V, Ramirez-Bosca A, Ramon-Vidal D, Ruzafa-Costas B, Genoves-Martinez S, Chenoll-Cuadros E, Carrion-Gutierrez M, Horga de la Parte J, Prieto-Merino D, Codoner-Cortes FM. Effect of Oral Administration of a Mixture of Probiotic Strains on SCORAD Index and Use of Topical Steroids in Young Patients With Moderate Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2018 Jan 1;154(1):37-43. doi: 10.1001/jamadermatol.2017.3647.
PubMed 29117309Prakoeswa CRS, Herwanto N, Prameswari R, Astari L, Sawitri S, Hidayati AN, Indramaya DM, Kusumowidagdo ER, Surono IS. Lactobacillus plantarum IS-10506 supplementation reduced SCORAD in children with atopic dermatitis. Benef Microbes. 2017 Oct 13;8(5):833-840. doi: 10.3920/BM2017.0011. Epub 2017 Oct 12.
PubMed 29022387Wu YJ, Wu WF, Hung CW, Ku MS, Liao PF, Sun HL, Lu KH, Sheu JN, Lue KH. Evaluation of efficacy and safety of Lactobacillus rhamnosus in children aged 4-48 months with atopic dermatitis: An 8-week, double-blind, randomized, placebo-controlled study. J Microbiol Immunol Infect. 2017 Oct;50(5):684-692. doi: 10.1016/j.jmii.2015.10.003. Epub 2015 Nov 27.
PubMed 26733351
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Lactobacillus Reuteri DSM 17938 to Evaluate Safety and Efficacy on Children With Mild or Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04265716
- Acronym / sponsor ID
- ADreuteri / CSUB0174
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Innovacion y Desarrollo de Estrategias en SaludUniversity, hospital or other
- Collaborators
- BioGaia AB
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 13 May 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 12 Feb 2020 (actual)
- 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.
This study evaluates the safety and efficacy of the probiotic L. reuteri vs control product as an adjuvant for improving the skin appearance of children with mild or moderate atopic dermatitis. All children will receive the standard of care. Half of the children will receive topical L. reuteri in emollient, while the other half will receive the standard of care plus control product
Detailed description
AD if a very frequent allergic skin disorders in children. Produce a negative significant impact on quality of life and related costs. Recently the changes of skin microbiota had been related with inadequate evolution of atopic dermatitis.
- reuteri had been identified with some effect to reduce skin inflammation and help to modulate inflammatory pathways on skin. Investigators expect using topical L. reuteri as adjuvant some improvement on skin appearance due to the mode of action previous referenced additionally to some potential changes on microbiome
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double blind, placebo controlled trial, 2 parallel arms. Children with mild or moderate atopic dermatitis will be randomly selected at the Pediatric Dermatologic Clinic-Hospital General GEA-Mexico if they fulfill selectioncriteria.
| Arm | Type | Receives |
|---|---|---|
| L. reuteri | Active comparator | Other: Topical L. reeuteriTopical administration of ointment with L. reuteri DSM17938, rubbed into skin twice per day |
| Placebo | Placebo comparator | Other: Topical L. reeuteriRubbed into skin twice per day |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children age 1 to 8 years old
- Atopic Dermatitis (AD) according to the criteria of Hanifin and Rajka
- SCORAD Index 15 to 50, inclusive
- Subjects whose parents or legal representative are willing to sign the informed consent
- When the child is 8, he/she must also give consent to participate in the study
Key exclusion criteria (11 listed)
- Use of phototherapy for atopic dermatitis
- Systemic or topic corticosteroids in tthe 30 days prior to the study
- Immunosuppressive or cytostatic drugs in the 2 months prior to the study
- Use of probiotics in the 2 weeks prior to the study
- Other allergic severe disease (asthma, allergic rhinitis)
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 |
|---|---|---|
| Topical L. reeuteriTubes with ointment containing L. reuteri DSM17938 | Other | L. reuteri, Placebo |
Primary outcome
Skin appearance modification
Time frame: 16 weeks
To evaluate the use of a topical emolient containing L. reuteri DSM17938, in terms of its effect on appearance and symptomology in children with mild to moderate atopic dermatitis evaluated by SCORAD test
5 secondary outcomes
Frequency of adverse events
Time frame: 16 weeks
Changes on Quality of life
Time frame: 16 weeks
Changes on Family Quality of life: Familys Dermatology Life Quality Index Score
Time frame: 16 weeks
Frecuency of rescue medications
Time frame: 16 weeks
Changes on Skin microbiota
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Background: PubMed 31721162Amalia N, Orchard D, Francis KL, King E. Systematic review and meta-analysis on the use of probiotic supplementation in pregnant mother, breastfeeding mother and infant for the prevention of atopic dermatitis in children. Australas J Dermatol. 2020 May;61(2):e158-e173. doi: 10.1111/ajd.13186. Epub 2019 Nov 12.
- Background: PubMed 31441896Yang W, Tu R, Hu Y, He T, Zhang W, Gu L, Liu H. Probiotics supplement for the prevention of eczema in children: Study protocol for a meta-analysis and systematic review. Medicine (Baltimore). 2019 Aug;98(34):e16957. doi: 10.1097/MD.0000000000016957.
- Background: PubMed 31117100Yan DC, Hung CH, Sy LB, Lue KH, Shih IH, Yang CY, Chen LC, Sun HL, Lee MS, Chambard J, Tanguy J, Hughes-Formella B, Nutten S, Blanchard C. A Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Oral Administration of a Heat-Treated Lactobacillus paracasei Supplement in Infants with Atopic Dermatitis Receiving Topical Corticosteroid Therapy. Skin Pharmacol Physiol. 2019;32(4):201-211. doi: 10.1159/000499436. Epub 2019 May 22.
- Background: PubMed 30465329Li L, Han Z, Niu X, Zhang G, Jia Y, Zhang S, He C. Probiotic Supplementation for Prevention of Atopic Dermatitis in Infants and Children: A Systematic Review and Meta-analysis. Am J Clin Dermatol. 2019 Jun;20(3):367-377. doi: 10.1007/s40257-018-0404-3.
- Background: PubMed 29117309Navarro-Lopez V, Ramirez-Bosca A, Ramon-Vidal D, Ruzafa-Costas B, Genoves-Martinez S, Chenoll-Cuadros E, Carrion-Gutierrez M, Horga de la Parte J, Prieto-Merino D, Codoner-Cortes FM. Effect of Oral Administration of a Mixture of Probiotic Strains on SCORAD Index and Use of Topical Steroids in Young Patients With Moderate Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2018 Jan 1;154(1):37-43. doi: 10.1001/jamadermatol.2017.3647.
- Background: PubMed 29022387Prakoeswa CRS, Herwanto N, Prameswari R, Astari L, Sawitri S, Hidayati AN, Indramaya DM, Kusumowidagdo ER, Surono IS. Lactobacillus plantarum IS-10506 supplementation reduced SCORAD in children with atopic dermatitis. Benef Microbes. 2017 Oct 13;8(5):833-840. doi: 10.3920/BM2017.0011. Epub 2017 Oct 12.
- Background: PubMed 26733351Wu YJ, Wu WF, Hung CW, Ku MS, Liao PF, Sun HL, Lu KH, Sheu JN, Lue KH. Evaluation of efficacy and safety of Lactobacillus rhamnosus in children aged 4-48 months with atopic dermatitis: An 8-week, double-blind, randomized, placebo-controlled study. J Microbiol Immunol Infect. 2017 Oct;50(5):684-692. doi: 10.1016/j.jmii.2015.10.003. Epub 2015 Nov 27.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical L. reeuteri in people with Atopic Dermatitis, run by Innovacion y Desarrollo de Estrategias en Salud at 1 site in Mexico.
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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 17 Mar 2020. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pedro Gutierrez-Castrellon, MD, PhD (+525540003000 ext. 1246, pedro.gutierrez@ideas-salud.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin appearance modification (time frame: 16 weeks). 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 NCT04265716, which also lists 7 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 17 Mar 2020.