Efficacy and Safety of a Multistrain Probiotic Formula to Boost the Immune Response to Influenza Virus Vaccination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 10
- 主要终点
- IgG antibodies against vaccine influenza antigens
研究概览
简要总结
Randomized clinical trial to determine whether a probiotic formulation containing 4 probiotic strains which belong to Lactiplantibacillus plantarum and Pediococcus acidilactici species can boost the immune response to influenza vaccination evaluated at 4 weeks in a population between 50 and 80 years of age. Secondary outcomes comprise evaluation of immune response at 8 weeks after vaccination, percentage of patients with seroconversion, incidence and duration of influenza-like infections and respiratory infections throughout a 4-month period and safety.
详细描述
Double blind, randomized, placebo-controlled clinical trial to determine whether supplementation with a probiotic formulation containing 4 probiotic strains (L. plantarum CECT 30292, CECT7484, CECT7485 and P. acidilactici CECT7483) can improve immune response to seasonal influenza vaccination. Subjects with age comprised between 50 and 80 years who meet inclusion and exclusion criteria will be randomized 1:1 to one of the following study groups: one will receive probiotic formulation for 28 days (1 capsule/day) and the other will receive placebo, starting the same day of the influenza vaccination. Main study outcome will be immune response at 4 weeks after vaccination, which will be determined by analysis of specific IgG antibodies in serum against influenza A and B. Secondary outcomes comprise serum titers of specific IgG at 8 weeks after vaccination, percentage of patients with seroconversion at 4 and 8 weeks, evaluation of influenza-like infections or respiratory infections throughout a 4-month period and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Both placebo and active product will be provided in identical packaging.
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects 50 - 80 years old receiving seasonal Influenza vaccine in season 2021-2022
- •Body mass index (BMI) 18.5-34.9 kg/m2
- •Willing to provide informed consent
- •Able to follow study procedures, according to the criteria of study investigator
排除标准
- •Hypersensitivity to any of the components of influenza vaccine
- •Previous influenza infection in the same season (from 01/09/2021)
- •Having received influenza vaccination in the previous season less than 9 months before study entry (from 01/01/2021)
- •Having received another vaccine -different from COVID19 vaccine- up to 1 month before study inclusion or planning to receive it 1 month after study inclusion
- •Active infection at the moment of study entry as diagnosed by study physician
- •History of severe allergic reactions (food and non-food), including severe asthma.
- •Receiving immunosuppressant therapy, displaying neutropenia, lymphopenia, AIDS, immunoglobulin deficiency, active oncological disease.
- •Daily ingestion of any food complement or food added with probiotics (including Actimel o similar products) 2 weeks before inclusion in the study
- •Acute pancreatitis, short bowel syndrome or active inflammatory bowel disease
- •Diagnosed from other pathologies that according to study physician may compromise the immunological function of the individual (such as immunodeficiencies, lupus, multiple sclerosis, among others)
- •Having received antibiotic treatment in the previous month
- •Exclusion criteria during the study:
- •Withdrawal from the study as per study investigator criteria, in case that study procedures are not followed by the participant
- •In case of adverse event that prevents them from following study procedures or complying with the treatments under study.
- •Failure to comply with study procedures: Complete less than 70% of the days in the patient's diary and/or take less than 80% of the days of the study products.
- •Receive any of the unauthorized treatments indicated in the selection criteria, with the exception of antibiotics that will be allowed under medical prescription.
结局指标
主要结局
IgG antibodies against vaccine influenza antigens
时间窗: 4 weeks (day 1 and day 28)
Titer of specific total IgG antibodies against vaccine influenza A and B antigens at day 28
次要结局
- Aspartate aminotransferase (GOT)(4 weeks (day 1, day 28))
- IgG antibodies against vaccine influenza antigens(8 weeks (day 1 and day 56))
- Incidence of fever(16 weeks (day 1, day 56))
- IgM antibodies against vaccine influenza antigens(8 weeks (day 1 and day 56))
- Incidence of any other respiratory infections (including COVID-19)(16 weeks (day 1, day 56))
- Duration of vaccine-related symptoms: injection-site pain, swelling, redness(1 week (day 1, day 7))
- Adverse events(8 weeks (day 56))
- Albumin(4 weeks (day 1, day 28))
- Alanine aminotransferase (AST)(4 weeks (day 1, day 28))
- Basic hemogram(4 weeks (day 1, day 28))
- Seroconversion(8 weeks (day 1,day 28 and 56))
- Use of analgesics and antibiotics(16 weeks (day 1, day 56))
- Severity of vaccine-related symptoms: injection-site pain, swelling, redness(1 week (day 1, day 7))
- Gamma-glutamil transpeptidase (GGT)(4 weeks (day 1, day 28))
- Incidence of influenza like infections (ILI)(16 weeks (day 1, day 56))
- Gastrointestinal symptoms(4 weeks (day 1, day 28))
- Alkaline phosphatase (ALP)(4 weeks (day 1, day 28))