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| ID | Type | Description | Link |
|---|---|---|---|
| AH-PSR-01 | Registry Identifier | Clinicaltrials.gov |
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| Name | Class |
|---|---|
| Whately-Smith Ltd, King's Langley,UK | UNKNOWN |
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This was a randomized, double blind,fixed dose, placebo controlled, parallel-group pilot study to obtain data on size and variance of treatment effects in subjects with mild to moderate Psoriasis.
This was a randomized, double blind,fixed dose, placebo controlled, parallel-group pilot study to obtain data on size and variance of treatment effects in subjects with mild to moderate Psoriasis. The target sample size of 60 was selected as a practical figure for recruitment purposes in one centre over 3 months.After a 2 week washout during which only emollients were applied to their psoriasis, patients attended for baseline assessment of psoriasis severity and blood tests.Subjects attended every 4 weeks for 12 weeks for clinical assessment and blood tests.Each patient once eligible{see inclusion & exclusion criteria} was allocated to either active treatment or placebo in identical packing for a total of 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo sachets contained 5 grams of Maltodextrin only. |
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| B Infantis 35624 | Experimental | Each 5gram freeze-dried powder contained ≥1*1010 Colony forming units (CFU) of B. infantis 35624/sachet. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B. Infantis 35624 | Dietary Supplement | One sachet daily for 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in the Psoriasis area and severity index between baseline and end of feeding | The PASI score stands for Psoriasis Area and Severity Index. This tool allows researchers to put an objective number on what would otherwise be a very subjective idea: how bad is a person's psoriasis. To make up the score, the three features of a psoriatic plaque (redness) scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. Then the extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72 | At 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Disability Index[PDI} | The Psoriasis Disability Index questionnaire is designed for use in adults, i.e. patients over the age of 16. It is self explanatory and can be handed to the patient who is asked to fill it in without the need for a detailed explanation. It is usually completed in three or four minutes. There are two possible alternative formats of the PDI. One uses visual analogue scales for each answer, the other uses tick box choices for each answer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liam O Mahony, Dr. | Alimentary Health Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alimentary Health Ltd | Cork | Ireland |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| at 12 weeks |