Active, not recruiting
Observational
Investigating the Effectiveness of 2 Different Doses of BIOHM FX Probiotic Blend in Improving Digestive Symptoms
Condition(s) studied
Moderate Gastrointestinal Discomfort
Investigational drug(s) / intervention(s)
BIOHM FX Probiotic Blend
BIOHM FX Probiotic Blend: 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 CFU to 1 Billion CFU. The probiotic blend consists of Lactobacillus acidophilus, Lactobacillus rhamnosus, Saccharomyces boulardii, Bifidobacterium breve and amylase. The blend is manufactured at cGMP facilities located in the United States and has attained self 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 FALCPA panel of allergens ensuring there are no allergens present in the blend.
Study summary
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.
Eligibility
Inclusion Criteria:
* 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 4-5.
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
- To observe the effect of two different doses of BIOHM FX Probiotic blend on digestive symptoms — 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.
Trial sites (1)
| Facility | City | Region | Status |
| People Science, Inc. |
Los Angeles |
California |
|