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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Combined Symptoms and Medication Score
研究概览
简要总结
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 Th1:Th2 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 and/or 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; 4)Faecal microbiota composition.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between 18 and 60 years of age.
- •Present a medical history of ARs defined according to the International Consensus on Rhinitis for at least 2 years.
- •Present a positive IgE sensitization test to dust mite allergen during the last 5 years.
- •* Participants may present various sensitizations to different allergen in addition to allergy to dust mite.
- •Present the criteria for moderate-to-severe persistent AR phenotype according to the Allergic Rhinitis and its Impact on Asthma (ARIA) classification:
- •The intensity of signs and symptoms interferes with sleep; interferes with daily activities, sports and leisure; interferes with work activities; and symptoms present are troublesome.
- •The symptoms are present more than 4 days a week and during more than 4 consecutive weeks.
- •Present symptomatology at the pre-selection visit. This is, present, according to ARIA criteria, 2 or more of the following symptoms during more than 1 hour a day: water rhinorrhoea; sneezing, especially paroxysmal; nasal obstruction; nasal puritis; with or without conjunctivitis.
- •Sign the informed consent form.
排除标准
- •Age under 18 or over 60 years old.
- •Present intolerances and/or food allergies related to the products of the study.
- •Being pregnant or intending to become pregnant.
- •Be in breastfeeding period.
- •Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
- •Present some chronic gastrointestinal disease.
- •Clinical history of anemia.
- •Having received antibiotic treatment up to 30 days before the start of the study.
- •Having received immunotherapy treatment for dust mite allergen before the start of the study and during the study.
- •Having received immunotherapy treatment for allergens other than dust mites up to 30 days before the start of the study and during the study.
- •Taking probiotics, prebiotics and/or postbiotics up to 30 days before the start of the study and during the study.
- •Present any disease with immune system involvement (HIV, autoimmune disease, hepatitis, cancer, etc.).
- •Having received chemotherapy or other immunosuppressive therapy during the previous year.
- •Medical history of surgical procedures of nasal cavity and sinuses, recent surgery of gastrointestinal tract or bariatric surgery (ever).
- •Being unable to follow the study guidelines.
研究组 & 干预措施
ES1 group
Participants treated with Bifidobacterium longum ES1 for 2 months.
干预措施: ES1 group (Dietary Supplement)
HT-ES1 group
Participants treated with heat treated version of ES1 for 2 months.
干预措施: HT-ES1 group (Dietary Supplement)
Control group
Participants treated with maltodextrin for 2 months.
干预措施: Control group (Dietary Supplement)
结局指标
主要结局
Combined Symptoms and Medication Score
时间窗: Daily for the thirteen weeks of the study.
Participants will complete the Combined Symptoms and Medication Score (CSMS) questionnaire daily in an online form. The CSMS questionnaire takes into account the severity of symptoms and the use of rescue medication to asses the efficacy of treatments for AR. The CSMS is the sum of daily symptom score (dSS) and the daily medication score (dMS) and has a range of 0 to 6. The mean CSMS will be calculated weekly for each study period, that is the basal period (first week until V1); the treatment period (period between V1 and V2 visits) and the follow-up period (period between V2 and V3 visits), from the sum of all daily CSMS during each week of the study and divided by the number of days of each week of the study.
次要结局
- Nasal and conjunctival symptoms (dSS)(Daily for the thirteen weeks of the study.)
- Change in serum TGF-β levels.(At week 2 and week 10.)
- Change in serum IL-8 levels.(At week 2 and week 10.)
- Conjunctival symptoms(Daily for the thirteen weeks of the study.)
- Use of other medications for AR.(Daily for the thirteen weeks of the study.)
- Change in experienced troublesome functional impairments.(At week 2, week 10 and week 14.)
- Change in serum IL-10 levels.(At week 2 and week 10.)
- Change in serum IL-19 levels.(At week 2 and week 10.)
- Use of rescue medication.(Daily for the thirteen weeks of the study.)
- Number of days without medication.(Daily for the thirteen weeks of the study.)
- Change in serum IFN-γ levels.(At week 2 and week 10.)
- Change in serum IL-4 levels.(At week 2 and week 10.)
- Nasal symptoms.(Daily for the thirteen weeks of the study.)
- Change in serum IL-12 levels.(At week 2 and week 10.)
- Change in serum IgE levels.(At week 2 and week 10.)
- Change in serum IL-13 levels.(At week 2 and week 10.)
- Change in stool IgA levels.(At week 2, week 10 and week 14.)
- Metagenomic analysis.(At week 2, week 10 and week 14.)