NCT01368029已完成1 期
Double Blind Randomized Controlled Trial to Evaluate the Safety of Lactobacillus Rhamnosus GG ATCC 53103 (LGG) Vs. Placebo in Elderly Subjects Receiving Trivalent Inactivated Influenza Vaccine
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Occurrence of adverse events that are possibly or probably related to administration of LGG
研究概览
简要总结
This is a phase I, randomized controlled trial to evaluate the safety of Lactobacillus rhamnosus GG (LGG) versus placebo in elderly subjects receiving the trivalent inactivated influenza vaccine. Lactobacilli are part of the normal flora of the intestine. LGG is one of several strains of Lactobacilli that is used as a probiotic or microorganism administered to confer "health benefits". Our research is focused on studying the possible therapeutic effects of LGG. The study hypotheses are:
- LGG or placebo administered twice daily will be safe and well tolerated in elderly subjects who have just received the trivalent inactivated influenza vaccine
- The immune response to the influenza vaccine at day 21, 28, 56, and at the end of the influenza season will be higher in the LGG group than the placebo group
- The occurrence rate of influenza like illness during the influenza season will be lower in the LGG group than in the placebo group
- The diversity of the microbiota in nasopharyngeal and stool specimens at day 21, 28, 56 and at the end of the influenza season will be greater in the LGG group than the placebo group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 65-80 years
- •Willing to complete the informed consent process
- •Able and willing to participate for the planned duration of the study, including availability for follow-up telephone contact
- •Is community dwelling for the past two years
- •Has received routine physical in the past two years
- •Has no new chronic conditions in the past two years
- •Identifies a primary care clinician
- •Has received recommended preventive services (Task Force for Clinical Preventive Services) for vaccination and cancer prevention/detection, e.g.:
- •Pneumococcal vaccination
- •Mammography
- •Screening colonoscopy for cancer
- •Willing to comply with protocol and report on compliance and side effects during the study period
- •Informed consent obtained and signed prior to screening
排除标准
- •Self-reported vaccination with influenza vaccine for the current season
- •Vaccination with any vaccine within the one month period prior to study enrollment or intent to receive any other vaccine during the study period
- •History of hypersensitivity to any influenza vaccine components including thimerosal or egg
- •History of Guillain-Barre syndrome
- •History of avoidance of egg and/or egg based products for any reason
- •Acute febrile illness within the week prior to immunization - immunization deferred until illness resolved
- •Consumption of supplements or food products containing LGG or probiotics for 28 days prior to the start of the study or consumption of yogurt that has the "live and active cultures" seal
- •Known or suspected allergies to probiotics, Lactobacillus, microcrystalline cellulose, gelatin, or antibiotics that may be used to treat LGG bacteremia or infection
- •Received oral or parenteral antibiotics within 4 weeks of enrollment or prescribed antibiotics on the day of enrollment
- •Drug or alcohol abuse within the previous 12 months
- •Hospitalization, major surgery or endoscopy within the last 3 months
- •Scheduled hospital admission within 3 months of enrollment
- •Resident of a nursing home or rehabilitation center
- •Presence of any of the following:
- •Grade 2 or higher abnormal vital signs or abnormalities on physical exam
- •Indwelling catheter or implanted hardware/prosthetic device or feeding tube
- •Current or within the last 2 years, any episode of bowel leak, acute abdomen, diverticulitis, bloody bowel movements or peptic ulcer disease, including any surgical procedure or current prescription medications for any of these conditions
- •Current or within the last 4 weeks, active bowel disease such as an episode of infectious or non-infectious diarrhea, constipation or vomiting lasting more than 12 hours or current prescription medications for any of these conditions
- •Any history of gastric or intestinal dysmotility, slowed transit time, variable small intestinal permeability, pancreatitis, history of disease or current prescription medication for any of these conditions
- •Any history of Hepatitis B or Hepatitis C infections, cirrhosis, or chronic liver disease
- •Underlying structural heart disease such as abnormal native heart valve replacement, Stage IV congestive heart failure
- •History of peripheral vascular disease or stroke
- •Immunosuppression including HIV positive, solid organ or stem cell transplant recipient, receiving any oral or parenteral immunosuppressive therapy, neutrophil count <500/mm^3, or an anticipated drop in the neutrophil count to <500/mm^3 or active or planned chemotherapy or radiotherapy
- •History of collagen vascular or autoimmune disease
- •End stage renal disease
- •History of chronic obstructive pulmonary disease or asthma
- •Diabetes or thyroid disease
- •Active tuberculosis (TB), defined as undergoing a work up for suspected active TB infection or currently on treatment for active TB
- •Positive drug or alcohol testing at screening or positive breathalyzer at baseline or an unwillingness to undergo drug and alcohol testing
- •Abnormal laboratory tests defined as any of the following:
- •White blood cell (WBC) <3.3 or > 12.0 K/microliter
- •Platelets < 125 K/microliter
- •Hemoglobin Males: < 12.0 g/dL; Females < 11.0 g/dL
- •Creatinine > 1.8 mg/dL
- •Blood Urea Nitrogen (BUN)> 27 mg/dL
- •Aspartate aminotransferase (AST) > 1.25 ULN
- •Alanine aminotransferase > 1.25 ULN
- •Alkaline phosphatase > 2.0 ULN
- •Bilirubin (total) > 1.5 ULN
- •Glucose (nonfasting) > 126 mg/dL
- •Positive HIV, Hepatitis B surface antigen or Hepatitis C antibody
- •Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the subject participating in the study or would make it unlikely the subject could complete the study
结局指标
主要结局
Occurrence of adverse events that are possibly or probably related to administration of LGG
时间窗: Subjects will be followed from the study start through the end of the influenza season (as defined by CDC) with an anticipated average for most subjects of 7 months.
Adverse events will be detected during study visits with standardized questionnaires, medical history, vital signs, physical examinations, laboratory tests and review of subject diaries as well as between study visits on telephone calls based on responses to adverse event questionnaires. Additionally, subjects are encouraged to call the PI or study staff at any time if they are experiencing an adverse event.
次要结局
- Occurrence of influenza like illness(Subjects will be followed from the study start through the end of the influenza season (as defined by CDC) with an anticipated average for most subjects of 7 months.)
- Anti-influenza mucosal immune response(Subjects will be followed from the study start through the end of the influenza season (as defined by CDC) with an anticipated average for most subjects of 7 months.)
- Changes in the richness and bacterial diversity of the nasopharyngeal and gut microbiota and presence of LGG in stool specimens by routine culture(Subjects will be followed from the study start through the end of the influenza season (as defined by CDC) with an anticipated average for most subjects of 7 months.)
- Anti-influenza systemic immune response(Subjects will be followed from the study start through the end of the influenza season (as defined by CDC) with an anticipated average for most subjects of 7 months.)
研究者
Patricia L. Hibberd
Chief; Division of Global Health; MGHfC
Massachusetts General Hospital
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Safety of Lactobacillus Rhamnosus GG Versus Placebo in Elderly Subjects Receiving Live Attenuated Influenza VaccineHealthyInfluenzaNCT01545349Patricia L. Hibberd30
招募中
1 期
A Phase 1b Study to Evaluate APL-1401 in Patients With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisNCT05743010Jiangsu Yahong Meditech Co., Ltd aka Asieris36
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VES001 in Healthy ParticipantsDementia, FrontotemporalNCT06226064Vesper Biotechnologies ApS78
终止
1 期
Dose Escalation Study of ALX-009 in Healthy Men and Cystic Fibrosis (CF) and Non-CF Bronchiectasis PatientsCystic FibrosisBronchiectasisNCT02598999Alaxia SAS92
已完成
1 期
Pharmacokinetic Profile of Voriconazole Inhalation Powder in Adult Subjects With AsthmaAsthmaNCT04576325TFF Pharmaceuticals, Inc.17