Clinical trial: Effect of Bifidobacterium Animalis Subsp. Lactis HN019 on Oral Lichen Planus (NCT03386643)

Eligibility criteria:
Inclusion Criteria:

          -  Clinical inclusion

               -  Adults ≥ 18 years old, both genres, who consent to participate of the study;

               -  Presence of symptomatic reticular lesion and/or white-gray papules. In
                  afro-descendent individuals, reticular lesions may be associated with
                  hyperpigmented lesions;

               -  Additional clinical features such as ulcerative, erythematous, plaque and bullous
                  lesions will be accepted in the presence of bilateral and symmetrical reticular
                  lesions.

          -  Histopathological inclusion criteria

               -  Presence of subepithelial infiltrate predominantly lymphocytic, in band and
                  confined to the subepithelial area.

               -  Liquefaction degeneration of the basal cells layer.

        Exclusion Criteria:

          -  Clinical exclusion criteria

               -  Exclusion of contact lichenoid lesions: the pattern of reticular lesion and / or
                  papules should not be present only in areas of physical contact with restorative
                  materials;

               -  Exclusion of lichenoid reaction to the drug: difficult to differentiate from OLP,
                  however it is necessary to report all drugs in use by the patient; the comparison
                  between patients on medication, and those who do not use medication is important
                  to establish subgroups of OLP;

               -  Exclusion of chronic graft versus host disease (GVHD): differentiation between
                  OLP and GVHD is established in most cases by medical history;

               -  Exclusion of immunocompromised patients or patients with systemic diseases of
                  high complexity.

               -  Exclusion of patients who have previously used probiotic bacteria in the last 4
                  weeks prior to the study.

          -  Histopathological criteria for exclusion • Presence of epithelial dysplasia, absence
             of the lymphocytic inflammatory infiltrate band and liquefaction degeneration.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers.  The rashes are mildly itchy. The patient has no other medical conditions and takes no medications.  Vital signs are normal.  On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer.  There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance.

Patient description (patient's own words): I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction.

Does the patient match the trial criteria? Entailment