Determination of the effect of oral administration of probiotic strains in the treatment of psoriasis
Design
Phase 3, parallel group, clinical trial, with consecutive sampling, including 60 patients, single blinded, computerized randomized with permuted blocks
Settings and conduct
The study is conducted in the dermatology clinic of Shiraz University of Medical Sciences with the daily consumption of probiotic capsules and topical mometasone in the intervention group, and daily consumption of placebo capsules and topical mometasone in the control group. The patients are assessed at the beginning of treatment, months 1, 2, and 3 by Psoriasis Area Severity Index (PASI) score. The patients and outcome assessors are blind to the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Plaque type psoriasis; 18 years of age or older; Involvement of 20% or less of body surface area
Exclusion criteria: Severe scalp psoriasis; Worsening of signs and symptoms of psoriasis during treatment; Pregnancy; Lactation; Consumption of any systemic treatment affecting psoriasis within the last three months , Antibiotic administration within the recent two weeks; Any signs and symptoms of bacterial infections; Concomitant skin diseases; Presence of significant liver diseases; Presence of significant chronic kidney diseases; Consumption of probiotic-containing products
Intervention groups
Intervention group: Daily consumption of Lactocare probiotic capsules (Zist takhmir company, Tehran, Iran), the once daily application of mometasone ointment on skin lesions and mometasone lotion on the scalp lesions for 3 months
Control group: Daily consumption of placebo capsules containing starch, once daily application of mometasone ointment on skin lesions and mometasone lotion on the scalp lesions for 3 months
Main outcome variables
Quantitative score of the clinical severity of psoriasis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140212016557N8
Registration date:2021-10-03, 1400/07/11
Registration timing:prospective
Last update:2021-10-03, 1400/07/11
Update count:0
Registration date
2021-10-03, 1400/07/11
Registrant information
Name
Mozhdeh Sepaskhah
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 712125239
Email address
sepaskhah@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral administration of probiotic strains with placebo on the clinical severity of psoriasis vulgaris
Public title
Effect of oral probiotic in the treatment of psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Plaque type psoriasis
18 years of age or older
Involvement of 20% or less of body surface area
Exclusion criteria:
Severe scalp psoriasis
Worsening of signs and symptoms of psoriasis during treatment
Pregnancy
Lactation
Consumption of any systemic treatment affecting psoriasis within the last three months before recruiting in the study
Antibiotic administration within the recent two weeks
Any signs and symptoms of bacterial infections
Concomitant skin diseases
Presence of significant liver diseases
Presence of significant chronic kidney diseases
Consumption of probiotic-containing products (including probiotic-containing foods)
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The participants were randomized using permuted block randomization (size of each block: 4), in individual units, using random allocation software. The output of software is a table that determines the patient receives probiotic or placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
Probiotic and placebo are packed in the similar packages and are numbered according the patients' codes. Investigator and care provider are aware of the types pf drugs. But, data collectors and outcome assessors are not aware of the medication of each patient.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz. Iran
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2021-09-08, 1400/06/17
Ethics committee reference number
IR.SUMS.MED.REC.1400.284
Health conditions studied
1
Description of health condition studied
psoriasis
ICD-10 code
L40.0
ICD-10 code description
psoriasis vulgaris
Primary outcomes
1
Description
Quantitative score of the clinical severity of psoriasis
Timepoint
At the beginning of treatment, months 1, 2, and 3 after treatment
Method of measurement
Psoriasis Area Severity Index (PASI) score
Secondary outcomes
1
Description
Qualitative clinical severity of psoriasis
Timepoint
Months 1, 2, and 3 after treatment
Method of measurement
Physician global assessment score
2
Description
Quality of life
Timepoint
At the beginning and end of treatment
Method of measurement
Dermatology quality of life index questionnaire
3
Description
Percentage of acceptable improvement
Timepoint
Months 1, 2, and 3 after treatment
Method of measurement
Percentage of people who achieve equal to or more than ۷۵% reduction in Psoriasis Area Severity Score
4
Description
Rate of improvement
Timepoint
Months 1, 2, and 3 after treatment
Method of measurement
Time of achievement of equal to or more than ۷۵% reduction in Psoriasis Area Severity Score
Intervention groups
1
Description
Intervention group: Daily consumption of Lactocare probiotic capsules (Zist takhmir company, Tehran, Iran), the once daily application of mometasone ointment on skin lesions and mometasone lotion on the scalp lesions for 3 months
Category
Treatment - Drugs
2
Description
Control group: Daily consumption of placebo capsules containing starch, once daily application of mometasone ointment on skin lesions and mometasone lotion on the scalp lesions for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic, Shahid Faghihi hospital
Full name of responsible person
Mozhdeh Sepaskhah
Street address
Dermatology clinic, Faghihi hospital, Zand St.
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5239
Email
sepaskhah@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Abbas Rezaianzade
Street address
Research Council, Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Research grant of the Research Council of Shiraz University of Medical Sciences
Grant code / Reference number
22635
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amir Nasiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5239
Email
amir_nasiri68@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mozhdeh Sepaskhah
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5239
Fax
+98 71 3231 9049
Email
sepaskhah@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mozhdeh Sepaskhah
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5239
Fax
+98 71 3231 9049
Email
sepaskhah@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available