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| ID | Type | Description | Link |
|---|---|---|---|
| CCSNUT002443 | Other Identifier | Johnson & Johnson Consumer Inc. |
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| Name | Class |
|---|---|
| Infinant Health, Inc. (formerly known as Evolve BioSystems, Inc.) | UNKNOWN |
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The purpose of this study is to assess the effect of B. infantis (EVC001) versus placebo supplementation, in healthy breastfed infants at risk of developing atopic dermatitis (AD), on cumulative incidence of physician-diagnosed AD during the first year of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B. infantis | Experimental | A once-daily feeding of activated B. infantis EVC001 (8.0 *10^9 colony forming units [CFU]) will be provided to infants for 12 weeks. |
|
| Placebo | Placebo Comparator | A once-daily oral feeding of lactose placebo will be provided to infants for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B. infantis | Other | Bifidobacterium longum subspecies infantis strain EVC001, designated a "Foods for Special Dietary Use" (FSDU), will be provided to infants once daily for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Atopic Dermatitis (AD) through Week 52 | Percentage of participants with atopic dermatitis (AD) through Week 52 will be reported. AD will be diagnosed if three of the following four criteria are met: 1) pruritus, 2) typical morphology and distribution (facial and extensor involvement), 3) chronic or chronically relapsing dermatitis, 4) personal or family history of atopic disease. | Up to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Infants with Adverse Events Through Weeks 12, 52 and 104 | The percentage of infants with AEs, serious adverse events (SAEs), AEs leading to discontinuation, and AEs related to the gastrointestinal system will be determined at Weeks 12, 52 and 104. | Up to Weeks 12, 52 and 104 |
| Percentage of Participants with Atopic Dermatitis (AD) Through Weeks 24 and 104 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuli Rautava, M.D., Ph.D. | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HUS Children and Adolescents, Clinical Trial Unit, Park Hospital | Helsinki | 00290 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22153774 | Background | Abrahamsson TR, Jakobsson HE, Andersson AF, Bjorksten B, Engstrand L, Jenmalm MC. Low diversity of the gut microbiota in infants with atopic eczema. J Allergy Clin Immunol. 2012 Feb;129(2):434-40, 440.e1-2. doi: 10.1016/j.jaci.2011.10.025. Epub 2011 Dec 6. | |
| 17349686 | Background | Abrahamsson TR, Jakobsson T, Bottcher MF, Fredrikson M, Jenmalm MC, Bjorksten B, Oldaeus G. Probiotics in prevention of IgE-associated eczema: a double-blind, randomized, placebo-controlled trial. J Allergy Clin Immunol. 2007 May;119(5):1174-80. doi: 10.1016/j.jaci.2007.01.007. Epub 2007 Mar 8. |
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|
| Lactose Placebo | Other | Powdered infant formula grade lactose will be provided to infants once daily for 12 weeks. |
|
Percentage of participants with AD through Week 24 and 104 will be reported. AD will be diagnosed if three of the following four criteria are met: 1) pruritus, 2) typical morphology and distribution (facial and extensor involvement), 3) chronic or chronically relapsing dermatitis, 4) personal or family history of atopic disease. |
| Up to Weeks 24 and 104 |
| Time to Onset of AD Through Weeks 52 and 104 | Time to onset of AD through Weeks 52 and 104 will be reported. | Up to Weeks 52 and 104 |
| Percentage of Infants with B. infantis Gut Colonization at Week 12 | Percentage of infants with B. infantis gut colonization at Week 12 will be reported. | Week 12 |
| Percentage of Participants with at least Mild Atopic Dermatitis (AD) Severity Based on the Eczema Area and Severity Index (EASI) Score at Weeks 12, 52, and 104 | Percentage of participants with at least mild Atopic Dermatitis (AD) severity based on the EASI score at Weeks 12, 52, and 104 will be reported. Physician rates severity of four parameters: erythema, infiltration, excoriation and lichenification on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Physician determines how much area is affected on a scale of 0 (none) to 6 (90 to 100%). A body region score is determined by multiplying the sum of the severity scores by the affected area score by a constant corresponding to the relative body surface area for that body region (20%, 30%, 20%, and 30%, respectively). The 4 body region scores are summed to yield the EASI score which ranges from 0 to 72, with a higher score indicating more severe AD. The AD onset in the study's population can be diagnosed throughout the study at either scheduled or unscheduled visits starting as early as 1 month of age. | At Weeks 12, 52, and 104 |
| Time to Onset of at least Mild Atopic Dermatitis (AD) Severity Based on the Eczema Area and Severity Index (EASI) Score | Time to onset of at least mild Atopic Dermatitis (AD) severity based on the EASI score up to Week 104 will be reported. Physician rates severity of four parameters: erythema, infiltration, excoriation and lichenification on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Physician determines how much area is affected on a scale of 0 (none) to 6 (90 to 100%). A body region score is determined by multiplying the sum of the severity scores by the affected area score by a constant corresponding to the relative body surface area for that body region (20%, 30%, 20%, and 30%, respectively). The 4 body region scores are summed to yield the EASI score which ranges from 0 to 72, with a higher score indicating more severe AD. The AD onset in the study's population can be diagnosed throughout the study at either scheduled or unscheduled visits starting as early as 1 month of age. | At the time of AD onset (up to Week 104) |
| Percentage of Participants with at least Mild AD Severity Based on the Patient-Oriented Eczema Measure (POEM) Score at Weeks 12, 52, and 104 | The POEM is a simple, valid, easily interpreted, and reproducible tool for assessing AD and monitoring aspects of the disease that are important to participants with AD. Study Personnel will interview Caregivers at time of AD diagnosis and (only for participants with AD) at Weeks 12, 52, and 104 to rate seven symptoms (itchy skin, sleep disturbance, bleeding skin, skin weeping/oozing, skin flaking, skin cracking, skin dryness/roughness) using a 5-point scale of frequency of occurrence during the previous week (no days, 1-2 days, 3-4 days, 5-6 days, every day). The total score is the sum of the 7 items which is ranged from 0 to 28; a high score is indicative of more severe AD. The AD onset in the study's population can be diagnosed throughout the study at either scheduled or unscheduled visits starting as early as 1 month of age. | At Weeks 12, 52, and 104 |
| Time to Onset of at least Mild AD Severity Based on the Patient-Oriented Eczema Measure (POEM) Score | The POEM is a simple, valid, easily interpreted, and reproducible tool for assessing AD and monitoring aspects of the disease that are important to participants with AD. Study Personnel will interview Caregivers at time of AD diagnosis and (only for participants with AD) at Weeks 12, 52, and 104 to rate seven symptoms (itchy skin, sleep disturbance, bleeding skin, skin weeping/oozing, skin flaking, skin cracking, skin dryness/roughness) using a 5-point scale of frequency of occurrence during the previous week (no days, 1-2 days, 3-4 days, 5-6 days, every day). The total score is the sum of the 7 items which is ranged from 0 to 28; a high score is indicative of more severe AD. The AD onset in the study's population can be diagnosed throughout the study at either scheduled or unscheduled visits starting as early as 1 month of age. | At the time of AD onset (up to Week 104) |
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