Investigating the Effectiveness of 2 Different Doses of BIOHM FX Probiotic Blend in Improving Digestive Symptoms

Running, not enrolling · Has a placebo group

Conditions studied: Moderate Gastrointestinal Discomfort

In brief

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.

Key facts

Study ID

NCT06782945

Run by

Biohm Technologies

People needed

141

Starts

2024-07-24

Expected to finish

2025-03-04

Last updated by the study team

2025-01-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• People Science, Inc. — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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