Ignite Creation Date:
2024-05-06 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05208528
Status:
RECRUITING
Last Update Posted:
2023-03-16
First Post:
2022-01-12
Brief Title:
Effect of the Probiotic ES1 and Its Inactivated Form HT-ES1 Over Symptomatology Asociated With Allergic Rhinitis
Sponsor:
Fundació Eurecat
Organization:
Fundació Eurecat
Study Overview
Official Title:
Effect of the Probiotic Bifidobacterium Longum ES1 and Its Inactivated Form by Heat HT-Bifidobacterium Longum ES1 Over Symptomatology Asociated With Allergic Rhinitis Parallel Randomized Controled and Double-Blind Intervention Trial
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MICRORIN_2
Brief Summary:
Allergic rhinitis AR is a health problem characterised by an inflammatory reaction in the nasal mucosa mediated by immunoglobulin Ig E and resulting from exposure to environmental allergens such as pollen and dust mites
AR symptoms can significantly affect the quality of life of patients suffering from AR causing substantial direct health care costs and indirect costs due to absenteeism from work
The effects of pharmacological treatments are not always fully effective and have adverse effects resulting in a significant proportion of AR patients continuing to experience symptoms or being dissatisfied
Considering the relationship between AR and intestinal microbiota IM the use of probiotics live microorganisms that when consumed in adequate amounts confer beneficial effects on the host emerges as a potential strategy to prevent or treat certain allergies There are different mechanisms of action by which probiotics may exert their effects on the treatment or prevention of allergies through modulation of the immune system and stimulation of tolerance Probiotics promote a change in IM In addition probiotics stimulate gut-associated lymphoid tissue modulating inflammation and immune reactions present in AR promoting a more favourable profile by increasing the production of the modulatory cytokines IL-10 and TGFβ by Treg cells Probiotics can restore the Th1Th2 balance by inducing Th1 responses through the production of IL-12 and interferon IFN-γ or by suppressing Th2 responses through the depletion of IL-4 In addition probiotics may exert immunomodulatory effects through stimulating mucosal IgA production
The hypothesis of the present study is that supplementation with the probiotic Bifidobacterium longum ES1 andor with the heat treated version of ES1 will decrease the symptomatology associated with AR and improve the quality of life of individuals by modulating IM and potentiating Treg cells and the Th1 response
The main objective of the present study is to determine the effects of supplementation with the probiotic Bifidobacterium longum ES1 and the heat treated version of ES1 HT-ES1 on the symptoms associated with AR
The secondary objectives of the study are to determine the effects of the treatments over 1 Quality of life 2 Blood immunological markers IFN-γ IL-12 IL-10 TGF-β IgE IL-4 IL-13 IL-19 and IL-8 3 Faecal immunological marker IgA 4Faecal microbiota composition
AR symptoms can significantly affect the quality of life of patients suffering from AR causing substantial direct health care costs and indirect costs due to absenteeism from work
The effects of pharmacological treatments are not always fully effective and have adverse effects resulting in a significant proportion of AR patients continuing to experience symptoms or being dissatisfied
Considering the relationship between AR and intestinal microbiota IM the use of probiotics live microorganisms that when consumed in adequate amounts confer beneficial effects on the host emerges as a potential strategy to prevent or treat certain allergies There are different mechanisms of action by which probiotics may exert their effects on the treatment or prevention of allergies through modulation of the immune system and stimulation of tolerance Probiotics promote a change in IM In addition probiotics stimulate gut-associated lymphoid tissue modulating inflammation and immune reactions present in AR promoting a more favourable profile by increasing the production of the modulatory cytokines IL-10 and TGFβ by Treg cells Probiotics can restore the Th1Th2 balance by inducing Th1 responses through the production of IL-12 and interferon IFN-γ or by suppressing Th2 responses through the depletion of IL-4 In addition probiotics may exert immunomodulatory effects through stimulating mucosal IgA production
The hypothesis of the present study is that supplementation with the probiotic Bifidobacterium longum ES1 andor with the heat treated version of ES1 will decrease the symptomatology associated with AR and improve the quality of life of individuals by modulating IM and potentiating Treg cells and the Th1 response
The main objective of the present study is to determine the effects of supplementation with the probiotic Bifidobacterium longum ES1 and the heat treated version of ES1 HT-ES1 on the symptoms associated with AR
The secondary objectives of the study are to determine the effects of the treatments over 1 Quality of life 2 Blood immunological markers IFN-γ IL-12 IL-10 TGF-β IgE IL-4 IL-13 IL-19 and IL-8 3 Faecal immunological marker IgA 4Faecal microbiota composition
Detailed Description:
Parallel randomized placebo-controlled and double-blind intervention trial
75 participants 25 in each group men and women aged between 18 and 60 years with moderate-severe persistent AR symptoms and dust mite allergy
The 75 study participants will be randomly divided into three groups depending on whether they receive supplementation with the probiotic Bifidobacterium longum ES1 supplementation with the heat treated version of ES1 HT-ES1 or placebo during the 2-month study period After the treatment period the volunteers will be followed up for one month
During the study patients will be able to continue using conventional drug treatment for AR including oral and local antihistamines oral and intranasal corticosteroids and intranasal decongestants
Intervention products are the probiotic Bifidobacterium longum ES1 ES1 the heat treated version of ES1 HT-ES1 and a placebo maltodextrin The delivery format of the products to the volunteers will be in capsules
The total duration of the study will be of 92 days 13 weeks
Each participant will perform 4 visits The study visits will be the following
a pre-selection visit to check inclusionexclusion criteria V0 day 1 week 1 and in case of meeting the criteria
a study start visit V1 day 8 -3 days week 2
a final study visit V2 day 64 - 3 days week 10
a study follow-up visit V3 day 92 - 3 days week 14
At visits V0 V1 V2 and V3 the use of any medications including over the counter will be checked
In visits V1 V2 participants must present themselves in fasting conditions of 8 hours to obtain blood In addition in visits V2 and V3 participants will be asked for the presence of adverse events that could be associated with the consumption or withdrawal of the study products
The products will be given in the V1 visit so that the participants will have all the necessary treatment to carry out the 8 weeks of study with the corresponding product
During the study and starting from visit V0 once the volunteer has been included in the study and signed the informed consent participants will record AR symptomatology andor the use of AR medication on a daily basis by using the CSMS questionnaire described by Pfaar O et al in an online format using the Microsoft Forms application During the study the research team will monitor compliance of the online questionnaire by the volunteer
Volunteers will be encouraged to maintain their dietary habits and to maintain their regular practice of physical activity during the study
Descriptive variables related to AR and demographic variables will be obtained from participants of the study by clinical history and interviewing at visit V0
In visits V1 V2 and V3 of the study health-related quality of life data will be obtained by means of the Rhinoconjunctivitis Quality of Life Questionnaire RQLQ according to Juniper E et al
For the collection of faeces in visits V1 V2 and V3 participants will be previously provided with a faeces collection kit two different labelled tubes one for metagenomic analysis and other for IgA determination will be provided
75 participants 25 in each group men and women aged between 18 and 60 years with moderate-severe persistent AR symptoms and dust mite allergy
The 75 study participants will be randomly divided into three groups depending on whether they receive supplementation with the probiotic Bifidobacterium longum ES1 supplementation with the heat treated version of ES1 HT-ES1 or placebo during the 2-month study period After the treatment period the volunteers will be followed up for one month
During the study patients will be able to continue using conventional drug treatment for AR including oral and local antihistamines oral and intranasal corticosteroids and intranasal decongestants
Intervention products are the probiotic Bifidobacterium longum ES1 ES1 the heat treated version of ES1 HT-ES1 and a placebo maltodextrin The delivery format of the products to the volunteers will be in capsules
The total duration of the study will be of 92 days 13 weeks
Each participant will perform 4 visits The study visits will be the following
a pre-selection visit to check inclusionexclusion criteria V0 day 1 week 1 and in case of meeting the criteria
a study start visit V1 day 8 -3 days week 2
a final study visit V2 day 64 - 3 days week 10
a study follow-up visit V3 day 92 - 3 days week 14
At visits V0 V1 V2 and V3 the use of any medications including over the counter will be checked
In visits V1 V2 participants must present themselves in fasting conditions of 8 hours to obtain blood In addition in visits V2 and V3 participants will be asked for the presence of adverse events that could be associated with the consumption or withdrawal of the study products
The products will be given in the V1 visit so that the participants will have all the necessary treatment to carry out the 8 weeks of study with the corresponding product
During the study and starting from visit V0 once the volunteer has been included in the study and signed the informed consent participants will record AR symptomatology andor the use of AR medication on a daily basis by using the CSMS questionnaire described by Pfaar O et al in an online format using the Microsoft Forms application During the study the research team will monitor compliance of the online questionnaire by the volunteer
Volunteers will be encouraged to maintain their dietary habits and to maintain their regular practice of physical activity during the study
Descriptive variables related to AR and demographic variables will be obtained from participants of the study by clinical history and interviewing at visit V0
In visits V1 V2 and V3 of the study health-related quality of life data will be obtained by means of the Rhinoconjunctivitis Quality of Life Questionnaire RQLQ according to Juniper E et al
For the collection of faeces in visits V1 V2 and V3 participants will be previously provided with a faeces collection kit two different labelled tubes one for metagenomic analysis and other for IgA determination will be provided
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None