A Randomized, Double-Blind, Placebo-Controlled Pilot Study Evaluating the Safety, Tolerability and Impact of Synbiotic Health's Bifidobacterium Pseudocatenulatum ED02 Probiotic Supplement on Gastrointestinal Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Impact and Tolerability
研究概览
简要总结
The Study Team identified Bifidobacterium pseudocatenulatum ED02 as a safe and effective probiotic strain isolated from a healthy human donor. Research by the Study Team indicates that this strain lacks harmful genetic traits and can successfully mitigate infections from hypervirulent pathogens like Klebsiella pneumoniae without adverse effects.
详细描述
Species within the genus Bifidobacterium are vital components of the human microbiome across all life stages, with B. pseudocatenulatum being a primary species found in adults. The Study Team highlighted that the specific strain ED02 was isolated from the fecal matter of a healthy adult after being enriched with the prebiotic xylooligosaccharides. To ensure the strain's safety for therapeutic use, the Study Team performed genome sequencing, which confirmed the absence of any virulence factors or antibiotic resistance genes. Furthermore, in vivo testing conducted by the Study Team demonstrated that ED02 provided significant health improvements in mice infected with hypervirulent Klebsiella pneumoniae. Throughout these trials, the Study Team observed no adverse events, supporting the potential of ED02 as a safe intervention for gastrointestinal and systemic health.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years and older, inclusive.
- •Willingness to refrain from taking probiotics or prebiotics during the study period.
- •Interested in understanding more about their gut health and the use of probiotic products.
- •If taking any OTC or prescription medications for anxiety (e.g. magnesium, anticholinergics, Buspirone, Tricyclics, MAOIs,) or other class of medication for anxiety, must be on a stable dose for at least 4 weeks prior to randomization and throughout the course of the study.
- •If using any cannabis-containing products, must be on a stable dose regimen for at least 4 weeks prior to randomization and throughout the course of the study.
- •If using any nicotine-containing products, must be on a stable regimen for at least 4 weeks prior to randomization and throughout the course of the study.
- •Willing to practice a reliable method of contraception for the duration of the study.
- •In good general health at the time of screening (Investigator discretion).
- •Able to read and understand English.
- •Able to read, understand, and provide informed consent.
- •Able to use a personal smartphone device and download Chloe by People Science.
- •Able to receive shipment of the product at an address within the United States.
- •Able to complete study assessments over the course of up to 15 weeks.
排除标准
- •Any potential participants who:
- •Do not have a personal smartphone, internet access, or unwilling to download Chloe.
- •Currently on a carnivore diet, raw food diet, fruitarian, liquid diet (does not include vegans or vegetarians).
- •Plan to make major changes in their diet during the study period.
- •Are not willing to complete stool samples.
- •Concomitant Therapies:
- •Participants receiving any investigational therapies or treatments within 30 days prior to randomization.
- •Participants currently taking or have taken antibiotics, probiotic, or prebiotic supplements within the past 4 weeks prior to randomization.
- •Participants using immunomodulating supplements, immunosuppressive medications, systemic steroids, antifungals or other medications known to significantly impact gastrointestinal function or microbiota.
- •Participants currently taking fiber supplements
- •Participants currently taking laxatives
- •Participants taking chronic NSAIDs
- •Participants taking Metformin
- •Other Illnesses or Conditions: Participants who have the following comorbidities or gastrointestinal illnesses are excluded:
- •Participants with a clinical diagnosis of any gastrointestinal illness, including but not limited to:
- •Inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
- •Gastroesophageal reflux disease (GERD)
- •Gastric or duodenal ulcers
- •Celiac disease
- •Diverticular disease
- •Chronic pancreatitis
- •Gastroparesis
- •Severe liver disease (e.g., cirrhosis, hepatitis, NAFLD acceptable)
- •Gallbladder disease (e.g., cholecystitis, cholelithiasis)
- •Gastrointestinal cancer (Colorectal, Intestinal, Stomach, Liver, Gallbladder)
- •Participants with a known or suspected gastrointestinal infection, such as:
- •Clostridium difficile infection
- •Helicobacter pylori infection
- •Parasitic infections (e.g., Giardia, Cryptosporidium)
- •Participants with a history of gastrointestinal bleeding or perforation.
- •Participants with autoimmune conditions, such as:
- •Multiple sclerosis
- •Rheumatoid Arthritis
- •Participants with an immunocompromised status.
- •Participants with uncontrolled diabetes.
- •Participants with a history of gastrointestinal surgery, excluding appendectomy and cholecystectomy.
- •Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder.
- •Currently pregnant, planning to become pregnant in the next 3 months, or breastfeeding.
- •Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes.
- •Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the study or impact the study outcomes.
- •Known hypersensitivity or previous allergic reaction to microcrystalline cellulose, magnesium stearate, or silicon dioxide.
- •Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator.
研究组 & 干预措施
Placebo Arm
Matching Placebo
干预措施: Placebo (Dietary Supplement)
Study Product Arm
Participants taking the Probiotic Supplement
干预措施: Bifidobacterium pseudocatenulatum (Dietary Supplement)
结局指标
主要结局
Impact and Tolerability
时间窗: 4 weeks
The primary objective of the study is to evaluate the impact and tolerability of the probiotic study product. This is measured by assessment of the number, frequency, and severity of adverse events (AEs), serious adverse events (SAEs) and AE withdrawals reported over the study product/placebo use period.
次要结局
- Gastrointestinal Symptoms(6 weeks)
- Daily Gastrointestinal Symptoms(4 weeks)
- Impact on Gut Microbiota(6 weeks)
- Safety of Probiotic (Blood Hematology Profile)(4 weeks)
- Safety of Probiotic (Blood Chemistry Profile)(4 weeks)