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Beginning Assessment of Cutaneous Treatment Efficacy of Roseomonas in Atopic Dermatitis

This study is currently recruiting participants.
Verified November 27, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT03018275
First Posted: January 12, 2017
Last Update Posted: December 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
  Purpose

Background:

Atopic dermatitis (AD) is a skin disease also called eczema. It is common in children and sometimes gets better on its own. However, chronic AD may cause asthma, food allergies, eye infections, and sleep problems. The cause of AD might be related to bacteria that live on the skin. Researchers want to see if introducing bacteria, R mucosa, from healthy skin onto the skin of someone with AD helps treat the disease.

Objective:

To test the safety and activity of R mucosa for treating AD.

Eligibility:

Part 1: People ages 18 and older with AD

Part 2: Children ages 7 17 with AD

Design:

Participants will be screened with:

Medical history

Physical exam

Examination of their AD

Blood and urine tests

At the baseline visit, participants will have blood tests and photos taken of their skin. They will get a supply of R mucosa and a memory aid to track their doses and record how they are feeling. Part 2 participants guardians will complete questionnaires about their child s AD.

Part 1 participants will spray R mucosa on their arm twice per week for 6 weeks.

Part 2 guardians will spray it on their child s arm twice per week for 16 weeks.

Participants will have follow-up visits to repeat some baseline tests and review their memory aid:

Part 1: Six weeks after the baseline visit

Part 2: Four times over 16 weeks; then 2 or 3 times for 1 year

Participants will be called or emailed to discuss how they are feeling:

Part 1: About 30 days after their last visit

Part 2: About every 10 days between visits


Condition Intervention Phase
Atopic Dermatitis Biological: Roseomonas mucosa Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Beginning Assessment of Cutaneous Treatment Efficacy of Roseomonas in Atopic Dermatitis Phase I/II

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):

Primary Outcome Measures:
  • A 50% reduction in antecubital-specific SCORing Atopic Dermatitis (SCORAD) with no adverse events related to product use. Frequency of solicited adverse events, unsolicited adverse events, serious adverse events, and death. [ Time Frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks, 8 months, 12 months, and 16 months ]

Secondary Outcome Measures:
  • A 30% improvement in the quality of life as measured by the validated Children's Dermatology Life Quality Index (CDLQI) [ Time Frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks, 8 months, 12 months, and 16 months ]
  • A 30% improvement in the quality of life as measured by the validated Family Dermatology Life Quality Index (FDLQI) [ Time Frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks, 8 months, 12 months, and 16 months ]

Estimated Enrollment: 70
Study Start Date: January 11, 2017
Estimated Study Completion Date: May 30, 2019
Estimated Primary Completion Date: May 30, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Vials of lyophilized R mucosa (10"3, 10"4, or 10"5 CFU)
Biological: Roseomonas mucosa
R mucosa grown in Hank's balanced salt solution. Bacteria is washed, quantitated spectrophotometrically, suspended in 10%-15% sucrose, and lyophilized.

Detailed Description:
The underlying pathology of atopic dermatitis (AD) consists of defective skin barrier function, susceptibility to Staphylococcus aureus skin infection, and immune imbalance. There is currently no cure for AD. Preclinical data in a mouse model of AD suggest that commensal Gram-negative bacteria (CGN), such as Roseomonas mucosa, from a healthy source can relieve symptoms of AD and have antimicrobial effects. In this study, we will first evaluate the safety of R mucosa-based biotherapy in young adults and adults with AD (age 16+ years), and then evaluate the safety and efficacy of R mucosa-based biotherapy in children (ages 7-16 years) with AD. Participants will receive twice-weekly doses of CGN biotherapy for 6 weeks (part 1, dose escalations at 2 and 4 weeks) or 4 months (part 2, possible dose escalations at 4 and 8 weeks). Participants in part 1 will be contacted 30 plus-minus 10 days after end of treatment for assessment of safety. Participants in part 2 will also be followed for 1 year after the end of treatment for evaluation of long-term efficacy and safety. This will be the first study to test cutaneous live biotherapeutic products for AD. We hypothesize that altering the strains of CGN on the skin of people with AD will improve the patient s clinical outcome. We do not expect serious toxicities because R mucosa is rarely pathogenic; reported cases of bacteremia have typically been associated with percutaneous catheters in immunocompromised patients, who are excluded from this study.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 99 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Inclusion Criteria for Young Adults and Adults with AD (Part 1)

  1. Age 16+ years
  2. SCORAD of at least 10
  3. Have a clinical diagnosis of AD with active involvement of the antecubital fossa
  4. Willing to allow storage of blood for future research
  5. No history of other skin disease
  6. Initiated or attempted standard of care therapy at least 6 months prior to enrollment
  7. Must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) when engaging in sexual activities that can result in pregnancy. The effects of CGN live biotherapy on the developing human fetus are unknown. Adequate contraception must be used consistently, beginning before the first dose and lasting for the duration of study participation. Participants of childbearing potential must have a negative pregnancy test result before they receive CGN live biotherapy. During the course of the study, if a participant becomes pregnant or suspects they are pregnant, then they should inform the study staff and their primary care physician immediately.

Inclusion Criteria for Children with AD (Part 2)

  1. Age 7-16 years
  2. SCORAD of at least 10
  3. Have a clinical diagnosis of AD with active involvement of the antecubital fossa
  4. Willing to allow storage of blood and bacterial swabs for future research
  5. Initiated or attempted standard of care therapy at least 6 months prior to enrollment
  6. Participants who have begun menstruating must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) when engaging in sexual activities that can result in pregnancy.

EXCLUSION CRITERIA:

  1. Presence of an indwelling venous or arterial catheter
  2. Individuals living with anyone with a diagnosed immunodeficiency, cardiac valvular disease, and/of indwelling catheter
  3. Precence of allergies to aimkacin, ciprofloxacin, gentamicin, levofloxacin, and tobramycin (which would preclude treatment of any unexpected infection)
  4. History of cardiac valvular disease
  5. Any history of grade 2 or higher neutropenia or leukopenia
  6. Clinical suspicion of immunodeficiency, liver disorder, kidney disorder, and/or HIV
  7. Pregnant or breastfeeding
  8. Any history of anti-TNF treatment
  9. Inability to demonstrate proper bacteria administration procedure despite coaching and training
  10. Use of fluoroquinolone or aminoglycoside antibiotics within 2 weeks of enrollment
  11. Any condition that, in the opinion of the investigator, contraindicates participation in this Study

Co-enrollment guidelines: Co-enrollment in other trials is restricted, other than enrollment on observational studies or those evaluating the use of a licensed medication. Study staff should be notified of co-enrollment as it may require the approval of the investigator.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018275


Contacts
Contact: Ian A Myles, M.D. (301) 451-8420 mylesi@niaid.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Ian A Myles, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03018275     History of Changes
Other Study ID Numbers: 170033
17-I-0033
First Submitted: January 11, 2017
First Posted: January 12, 2017
Last Update Posted: December 7, 2017
Last Verified: November 27, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Lyophilized Biotherapeutic, Microbiome, Probiotic
Commensal Gram-negative Bacteria
Staphylococcus Aureus
Transepidermal Water Loss
Allergic Diseases

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases