A Direct-to-Consumer Placebo-controlled Study Investigating the Effectiveness of 2 Different Doses of BIOHM FX Probiotic Blend in Improving Digestive Symptoms in Individuals With Moderate Gastrointestinal Discomfort
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- To observe the effect of two different doses of BIOHM FX Probiotic blend on digestive symptoms
研究概览
简要总结
The rationale for this study is to observe the effect of two different doses of a consumer-grade probiotic product called FX Probiotic Blend on digestive symptoms in individuals with moderate gastrointestinal discomfort. Additionally, the study aims to observe the effects of the probiotic product on anxiety and quality of life, as well as effects on gut microbiota via activities and technologies that can successfully and effectively be completed and utilized in a home setting. Because this product is currently available in the overt the counter (OTC) market across the United States, a consumer-driven, decentralized observational clinical research study is therefore well-suited for examining the effects of this probiotic product in this population.
详细描述
Digestive health has garnered significant attention among consumers as evidenced by the 2012 National Health Initiative Survey (NHIS) reporting approximately 4 million adults using dietary supplements aimed at enhancing digestive wellness. Probiotics which are beneficial bacteria and yeast primarily residing in the gastrointestinal tract are available as dietary supplements and are present in naturally occurring foods such as yogurt, kefir, sauerkraut, tempeh and kimchi. Previous research indicates improved digestive health, immune boosting and improved mental health, yet further investigation is warranted. This study aims to assess the impact of oral supplementation with a probiotic blend on gastrointestinal symptoms and alterations in microbiome composition.
BIOHM Health has been selling BIOHM FX, a blend of probiotics as a dietary supplement addressed at the digestive health market since 2017. The blend is present in the market in various concentrations ranging from 30 Billion colony forming units (CFU) to 1 Billion colony forming units (CFU). The probiotic blend consists of Lactobacillus acidophilus, Lactobacillus rhamnosus, Saccharomyces boulardii, Bifidobacterium breve and amylase. The blend is manufactured at Current Good Manufacturing Practice (cGMP) facilities located in the United States and has attained self Generally Recognized as Safe (GRAS) status. Prior to release, each lot of probiotic blend is tested for heavy metals, objectionable organisms, water content, probiotic potency, enzyme activity level and allergens, Soy, Milk and Gluten. Additionally, BIOHM performs annual testing for a full Food Allergen Labeling and Consumer Protection Act (FALCPA) panel of allergens ensuring there are no allergens present in the blend.
BIOHM FX has previously been studied to show a number of digestive health-related properties such as supporting healthy digestion, reduced bloating, flatulence, abdominal pain and constipation. Additionally BIOHM FX has been shown to break down polymicrobial biofilms, and support healthy candida levels.
The rationale for this study is to observe the effect of two different doses of a consumer-grade probiotic product called FX Probiotic Blend on digestive symptoms in individuals with moderate gastrointestinal discomfort. Additionally, the study aims to observe the effects of the probiotic product on anxiety and quality of life, as well as effects on gut microbiota via activities and technologies that can successfully and effectively be completed and utilized in a home setting. Because this product is currently available in the over the counter (OTC) market across the United States, a consumer-driven, decentralized observational clinical research study is therefore well-suited for examining the effects of this probiotic product in this population.
The study team will examine the outcomes in a broad age-range of adults who have chosen to try this product. The study will incorporate participant reported outcome questionnaires and surveys and at-home stool collection. There is no "doctor-patient" relationship as part of this research since the participant as a consumer is making the informed choice to take the product and take part in the observational process with self-reported measures and at-home sample collection. Findings from this study will contribute knowledge toward the dosing and formulation of the probiotic product and the design of future studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18-75 years old, inclusive
- •Has self-reported moderate digestive symptoms, such as abdominal pain, bloating, flatulence, constipation, or diarrhea.
- •Has a moderate Gastrointestinal Symptom Rating Scale (GSRS) score between 4-
- •Willingness to refrain from taking probiotics or prebiotics during the study period.
- •Interested in understanding more about their gut health and the use 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 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.
- •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 7 weeks.
排除标准
- •Do not have a personal smartphone, internet access, or unwilling to download Chloe.
- •Concomitant Therapies:
- •Participants receiving any investigational therapies or treatments within 30 days prior to randomization.
- •Participants currently taking or have taken antibiotics, probiotics, or prebiotics within the past 4 weeks prior to randomization.
- •Participants using immunosuppressive medications, systemic steroids, antifungals or other medications known to significantly impact gastrointestinal function or microbiota.
- •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 (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 surgery, excluding appendectomy and cholecystectomy.
- •Participants with a history of gastrointestinal bleeding or perforation.
- •Currently diagnosed with Alcohol Abuse and/or Substance Use Disorder
- •Currently pregnant, planning to become pregnant in the next 1 month, or breastfeeding
- •Willing to practice a reliable method of contraception for the duration of the study
- •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.
结局指标
主要结局
To observe the effect of two different doses of BIOHM FX Probiotic blend on digestive symptoms
时间窗: 6 weeks
Change in the Gastrointestinal Symptom Rating Scale (GSRS) score between placebo and study product groups. Baseline period will be compared as well as GSRS scores between the two doses. The score is calculated by using a 7-point Likert scale to rate the frequency and intensity of symptoms experienced over the previous week. A higher score indicates more severe symptoms and worse outcomes.
次要结局
- To assess the effect of two different doses of BIOHM FX Probiotic blend on gut microbiome markers(6 weeks)
- To assess the effect of two different doses of BIOHM FX Probiotic blend on anxiety(6 weeks)
- To assess the effect of two different doses of BIOHM FX Probiotic blend on gastrointestinal symptoms (i.e. flatulence, bloating, abdominal discomfort, stool consistency/ regularity, constipation)(6 weeks)
- To assess the effect of two different doses of BIOHM FX Probiotic blend on quality of life(6 weeks)
- To observe the safety and tolerability of two different doses of BIOHM FX Probiotic blend(6 weeks)