PsoriasisPhase 1/2AH-PSR-01NCT01451346
Study in Patients With Mild to Moderate Psoriasis
A Phase 1/2 study testing B. Infantis 35624 in people with Psoriasis, run by Alimentary Health Ltd at 1 site in Ireland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- B. Infantis 35624
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteIreland
- Study dates
- Jan 2008to Aug 2011
- Phase
- Phase 1/2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects diagnosed with mild to moderate psoriasis as defined by the clinician,
- Has a Psoriasis Area and Severity Index{PASI} of less than 20,
- Male or female subjects,
- Aged between 18-60 years of age,
- Non-pregnant female and must agree to use adequate method of contraception during the study,
- Is capable of giving written informed consent prior to study entry,
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- Be willing to refrain from taking dietary supplements or other foods that contain fermented live bacteria within 1 month prior to treatment and during the study,
- Have not participated in a clinical drug study or used an investigational new drug during the past previous 30 days,
- Clinical Chemistry and haematology results from Visit 1 are within normal limits,
- Be willing to refrain from using any topical psoriactic cream 2 weeks prior to treatment and during the study.
Who cannot join
- Are less than 18 years of age, and not more than 60 years of age,
- History of sensitivity to lactose [eg, lactose intolerance] or other dairy products,
- History of consumption of probiotics,1 month prior to treatment,
- Being treated with steroids 2 weeks prior to entry, Diseases of the gastrointestinal tract,liver,pancreas and biliary tree[eg;gastritis,symptomatic gall stones,duodenal ulcer,gastroenteritis,diverticulitis.] Exceptions include haemorrhoids,hiatus hernia and asymptomatic gall stones.
- History of major gastric,hepatic,pancreatic or intestinal surgery or perforation,excluding cholescystectomy,appendicectomy,haemorrhoidectomy or polypectomy.
- Recent unexplained rectal bleeding and/or significant unexplained weight loss.
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- Antibiotic use within one month prior to Visit 1. have a significant acute or chronic coexisting illness{cardiovascular,gastrointestinal,immunological}or a condition, which contraindicates,in the investigators judgement entry to the study.
- Patients with Diabetes Mellitus.
- Individuals who, in the opinion of the investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial.
- Subjects currently receiving treatment involving experimental drugs.
- If a subjects has been in a recent experimental trial,must be not less than 30 days prior to this study.
- Have a concomitant end stage organ disease eg; cardiovascular,hepatic,pulmonary,renal,which , in the Investigators judgement,contraindicates participation in the study.
- Have a history of malignancy in the past 5 years with the exception of Basal Cell Carcinoma.
- Evidence of alcohol or drug abuse.
- Evidence of unstable forms of psoriasis,including guttate, erthrodermic , exfoliative or pustular psoriasis.
- Evidence of other inflammatory skin disease that may confound the evaluation of psoriasis.
- Has had systematic antipsoriatic treatment or PUVA therapy within the previous 4 weeks.
- Subject who has had UVB therapy with the previous 2 weeks.
- If the subjects scores >20% on the PASI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: B.Infantis 35624 in Patients With Mild to Moderate Chronic Plaque Psoriasis -a Pilot Study
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.
Read the detailed description
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.
- Conditions
- Psoriasis
- Being tested
- B. Infantis 35624
- Keywords
- Pilot study
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B. Infantis 35624Dietary supplement
One sachet daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo sachets contained 5 grams of Maltodextrin only. Receives: Dietary Supplement: B. Infantis 35624 |
| B Infantis 35624 | Experimental | Each 5gram freeze-dried powder contained ≥1*1010 Colony forming units (CFU) of B. infantis 35624/sachet. Receives: Dietary Supplement: B. Infantis 35624 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 12 weeks
Secondary outcomes (1)
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
Measured: at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
- Study startJan 2008
- Primary completionApr 2008
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alimentary Health Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Whately-Smith Ltd, King's Langley,UK
- Responsible party
- Sponsor
- Investigators
- Liam O Mahony, Dr., Study director, Alimentary Health Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451346
- Sponsor's protocol ID
- Psoriasis Pilot Study
- Other IDs
- AH-PSR-01
- Acronym
- AH-PSR-01
- Status last verified
- Oct 2011
- First submitted
- 3 Oct 2011
- Last updated
- 13 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B.Infantis 35624 in Patients With Mild to Moderate Chronic Plaque Psoriasis -a Pilot Study
- ClinicalTrials.gov ID
- NCT01451346
- Acronym / sponsor ID
- AH-PSR-01 / Psoriasis Pilot Study
- Conditions
- Psoriasis
- Keywords
- Pilot study
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Alimentary Health LtdIndustry (pharma, biotech, devices)
- Collaborators
- Whately-Smith Ltd, King's Langley,UK
- Study start
- Jan 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 13 Oct 2011 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: B. Infantis 35624Placebo sachets contained 5 grams of Maltodextrin only. |
| B Infantis 35624 | Experimental | Dietary Supplement: B. Infantis 35624Each 5gram freeze-dried powder contained ≥1*1010 Colony forming units (CFU) of B. infantis 35624/sachet. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subjects diagnosed with mild to moderate psoriasis as defined by the clinician,
- Has a Psoriasis Area and Severity Index{PASI} of less than 20,
- Male or female subjects,
- Aged between 18-60 years of age,
- Non-pregnant female and must agree to use adequate method of contraception during the study,
Key exclusion criteria (19 listed)
- Are less than 18 years of age, and not more than 60 years of age,
- History of sensitivity to lactose [eg, lactose intolerance] or other dairy products,
- History of consumption of probiotics,1 month prior to treatment,
- Being treated with steroids 2 weeks prior to entry, Diseases of the gastrointestinal tract,liver,pancreas and biliary tree[eg;gastritis,symptomatic gall stones,duodenal ulcer,gastroenteritis,diverticulitis.] Exceptions include haemorrhoids,hiatus hernia and asymptomatic gall stones.
- History of major gastric,hepatic,pancreatic or intestinal surgery or perforation,excluding cholescystectomy,appendicectomy,haemorrhoidectomy or polypectomy.
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 |
|---|---|---|
| B. Infantis 35624One sachet daily for 12 weeks | Dietary supplement | B Infantis 35624, Placebo |
Primary outcome
Change in the Psoriasis area and severity index between baseline and end of feeding
Time frame: At 12 weeks
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
1 secondary outcome
Psoriasis Disability Index[PDI}
Time frame: at 12 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 13 Oct 2011.
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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.
Liam O Mahony, Dr. study director
Alimentary Health Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing B. Infantis 35624 in people with Psoriasis, run by Alimentary Health Ltd at 1 site in Ireland.
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 10 inclusion and 19 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 13 Oct 2011. 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 Ireland. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 in the Psoriasis area and severity index between baseline and end of feeding (time frame: At 12 weeks). 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 13 Oct 2011.