Efficacy of Probiotic Capsules With Topical Clobetasol Propionate in OLP Treatment
NCT ID: NCT06119672
Last Updated: 2023-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
36 participants
INTERVENTIONAL
2023-05-01
2023-12-30
Brief Summary
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-The intervention group (Group P): This group will be randomly allocated to take one capsule twice daily during meal time at morning and evening of probiotics complex obtained from Biovea for 4 -week study period. Moreover, patients in this group will be instructed to apply clobetasole propionate in orabase gel 2 times daily for 4 weeks. Patients will receive their supply of the gel and probiotics every 2 weeks. The control group (Group B): This group will be randomly allocated to apply clobetasol propionate in orabase gel 4 times daily after meal times and before sleeping for 4 weeks. At the 3rd week this group will be instructed to apply miconazole gel 4 times daily as a prophylaxis for two weeks.
Salivary sample collection: Unstimulated salivary sample was collected from all participants twice , once at baseline and another time after 4 weeks from the study period. Saliva was collected in graduated clear test tubes to be used in the evaluation of candidal counts before and after treatment .
Patient's visits was at baseline, 2 weeks and 4 weeks.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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systemic probiotic (A)
Systemic probiotic capsules will be given twice daily in addition to topical application of topical clobetasol in orabase twice daily
Probiotic Blend Oral capsules
probtiotic bend oral tablets from biovia will be adminestrated containing 4 strains ( twice daily) in addition to topical clobetasol application twice daily
Corticosteroids for Local Oral Treatment
topical clobetasol probionate in orabase application 4 times daily
topical corticosteroid (B)
topical clobetasol in orabse application will be given 4 times daily ( 3 times after meals and once before bed time) prophylactic topical antifungal will be given in the fourth week to prevent candidal infection
Corticosteroids for Local Oral Treatment
topical clobetasol probionate in orabase application 4 times daily
Interventions
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Probiotic Blend Oral capsules
probtiotic bend oral tablets from biovia will be adminestrated containing 4 strains ( twice daily) in addition to topical clobetasol application twice daily
Corticosteroids for Local Oral Treatment
topical clobetasol probionate in orabase application 4 times daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female patient with age range between 20-75 years old were included.
* medically free individuals
Exclusion Criteria
* Pregnant females
* patients with history of systemic disorder affecting the immune system
* active liver diseases and cancer
* allergy or intolerance to probiotics.
* any other oral lesions
20 Years
75 Years
ALL
No
Sponsors
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Cairo University
OTHER
October 6 University
OTHER
Responsible Party
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Amira Abdelwhab
lecturer
Principal Investigators
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yasmine kamal, lecturer
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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Cairo University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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311122
Identifier Type: -
Identifier Source: org_study_id
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