A proof of concept pilot trial of probiotics in symptomatic oral lichen planus (CABRIO)

Erni Marlina; Richard Goodman; Valeria Mercadante; Martina Shephard; Roddy McMillan; Tim Hodgson; Rachel Leeson; Stephen Porter; Julie A. Barber; Stefano Fedele; Andrew M. Smith

doi:10.1111/odi.14014

A proof of concept pilot trial of probiotics in symptomatic oral lichen planus (CABRIO)

Erni Marlina, Richard Goodman, Valeria Mercadante, Martina Shephard, Roddy McMillan, Tim Hodgson, Rachel Leeson, Stephen Porter, Julie A. Barber, Stefano Fedele, Andrew M. Smith

Research output: Contribution to journal › Article › peer-review

7 Citations (Scopus)

Abstract

Objective

To preliminary evaluate the clinical effects of probiotics in individuals with symptomatic oral lichen planus and the possible mechanisms of action.

Subjects and Methods

A group of 30 individuals with symptomatic oral lichen planus were recruited in a randomised double-blind parallel group controlled (1:1) proof-of-concept pilot trial of probiotic VSL#3 vs placebo. Efficacy outcomes included changes in pain numeric rating scale, oral disease severity score and the chronic oral mucosal disease questionnaire. Adverse effects, home diary and withdrawals were assessed as feasibility outcomes. Mechanistic outcomes included changes in salivary and serum levels of CXCL10 and IFN-γ and in oral microbial composition.

Results

The probiotic VSL#3 was safe and well tolerated. We observed no statistically significant change in pain, disease activity, quality of life, serum/salivary CXCL10 or oral microbial composition with respect to placebo. Salivary IFN-γ levels demonstrate a trend for a reduced level in the active group (p = 0.082) after 30 days of probiotic consumption.

Conclusions

The present proof-of-concept study provides some weak not convincing indication of biological and clinical effects of probiotic VSL#3 in individuals with painful oral lichen planus. Further research in this field is needed, with the current study providing useful information to the design of future clinical trials.

Original language	English
Pages (from-to)	2155-2167
Number of pages	13
Journal	Oral Diseases
Volume	28
Issue number	8
Early online date	31 Aug 2021
DOIs	https://doi.org/10.1111/odi.14014
Publication status	E-pub ahead of print - 31 Aug 2021

Keywords

oral lichen planus
probiotic
the clinical and biological effects of the use of probiotic in patients with oral lichen planus
VSL#3

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title = "A proof of concept pilot trial of probiotics in symptomatic oral lichen planus (CABRIO)",

abstract = "ObjectiveTo preliminary evaluate the clinical effects of probiotics in individuals with symptomatic oral lichen planus and the possible mechanisms of action.Subjects and MethodsA group of 30 individuals with symptomatic oral lichen planus were recruited in a randomised double-blind parallel group controlled (1:1) proof-of-concept pilot trial of probiotic VSL\#3 vs placebo. Efficacy outcomes included changes in pain numeric rating scale, oral disease severity score and the chronic oral mucosal disease questionnaire. Adverse effects, home diary and withdrawals were assessed as feasibility outcomes. Mechanistic outcomes included changes in salivary and serum levels of CXCL10 and IFN-γ and in oral microbial composition.ResultsThe probiotic VSL\#3 was safe and well tolerated. We observed no statistically significant change in pain, disease activity, quality of life, serum/salivary CXCL10 or oral microbial composition with respect to placebo. Salivary IFN-γ levels demonstrate a trend for a reduced level in the active group (p = 0.082) after 30 days of probiotic consumption.ConclusionsThe present proof-of-concept study provides some weak not convincing indication of biological and clinical effects of probiotic VSL\#3 in individuals with painful oral lichen planus. Further research in this field is needed, with the current study providing useful information to the design of future clinical trials.",

keywords = "oral lichen planus, probiotic, the clinical and biological effects of the use of probiotic in patients with oral lichen planus, VSL\#3",

author = "Erni Marlina and Richard Goodman and Valeria Mercadante and Martina Shephard and Roddy McMillan and Tim Hodgson and Rachel Leeson and Stephen Porter and Barber, \{Julie A.\} and Stefano Fedele and Smith, \{Andrew M.\}",

year = "2021",

month = aug,

day = "31",

doi = "10.1111/odi.14014",

language = "English",

volume = "28",

pages = "2155--2167",

journal = "Oral Diseases",

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T1 - A proof of concept pilot trial of probiotics in symptomatic oral lichen planus (CABRIO)

AU - Marlina, Erni

AU - Goodman, Richard

AU - Mercadante, Valeria

AU - Shephard, Martina

AU - McMillan, Roddy

AU - Hodgson, Tim

AU - Leeson, Rachel

AU - Porter, Stephen

AU - Barber, Julie A.

AU - Fedele, Stefano

AU - Smith, Andrew M.

PY - 2021/8/31

Y1 - 2021/8/31

N2 - ObjectiveTo preliminary evaluate the clinical effects of probiotics in individuals with symptomatic oral lichen planus and the possible mechanisms of action.Subjects and MethodsA group of 30 individuals with symptomatic oral lichen planus were recruited in a randomised double-blind parallel group controlled (1:1) proof-of-concept pilot trial of probiotic VSL#3 vs placebo. Efficacy outcomes included changes in pain numeric rating scale, oral disease severity score and the chronic oral mucosal disease questionnaire. Adverse effects, home diary and withdrawals were assessed as feasibility outcomes. Mechanistic outcomes included changes in salivary and serum levels of CXCL10 and IFN-γ and in oral microbial composition.ResultsThe probiotic VSL#3 was safe and well tolerated. We observed no statistically significant change in pain, disease activity, quality of life, serum/salivary CXCL10 or oral microbial composition with respect to placebo. Salivary IFN-γ levels demonstrate a trend for a reduced level in the active group (p = 0.082) after 30 days of probiotic consumption.ConclusionsThe present proof-of-concept study provides some weak not convincing indication of biological and clinical effects of probiotic VSL#3 in individuals with painful oral lichen planus. Further research in this field is needed, with the current study providing useful information to the design of future clinical trials.

AB - ObjectiveTo preliminary evaluate the clinical effects of probiotics in individuals with symptomatic oral lichen planus and the possible mechanisms of action.Subjects and MethodsA group of 30 individuals with symptomatic oral lichen planus were recruited in a randomised double-blind parallel group controlled (1:1) proof-of-concept pilot trial of probiotic VSL#3 vs placebo. Efficacy outcomes included changes in pain numeric rating scale, oral disease severity score and the chronic oral mucosal disease questionnaire. Adverse effects, home diary and withdrawals were assessed as feasibility outcomes. Mechanistic outcomes included changes in salivary and serum levels of CXCL10 and IFN-γ and in oral microbial composition.ResultsThe probiotic VSL#3 was safe and well tolerated. We observed no statistically significant change in pain, disease activity, quality of life, serum/salivary CXCL10 or oral microbial composition with respect to placebo. Salivary IFN-γ levels demonstrate a trend for a reduced level in the active group (p = 0.082) after 30 days of probiotic consumption.ConclusionsThe present proof-of-concept study provides some weak not convincing indication of biological and clinical effects of probiotic VSL#3 in individuals with painful oral lichen planus. Further research in this field is needed, with the current study providing useful information to the design of future clinical trials.

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KW - probiotic

KW - the clinical and biological effects of the use of probiotic in patients with oral lichen planus

KW - VSL#3

U2 - 10.1111/odi.14014

DO - 10.1111/odi.14014

M3 - Article

SN - 1354-523X

VL - 28

SP - 2155

EP - 2167

JO - Oral Diseases

JF - Oral Diseases

IS - 8

ER -

A proof of concept pilot trial of probiotics in symptomatic oral lichen planus (CABRIO)

Abstract

Keywords

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