A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Impact of CLB101TM️ on Gut Health in Healthy, Overweight Individuals

Prior treatment

• Participants who are currently on a carnivore diet, raw food diet, fruitarian, liquid diet (does not include vegans or vegetarians).
• 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 immunosuppressive medications, systemic steroids, antifungals, NSAIDs or other medications known to significantly impact gastrointestinal function or microbiota.

Other illness

• 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)
• Celiac disease
• Diverticular disease
• 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 Use Disorder and/or Substance Use Disorder.
• 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.

Lab values

• Known hypersensitivity or previous allergic reaction to probiotics, microcrystalline cellulose, vegetarian capsules, silica, or magnesium stearate.

Other

• Participants that do not have a personal smartphone, internet access, or unwilling to download Chloe.
• Gastric or duodenal ulcers
• Chronic pancreatitis
• Gastroparesis
• Currently pregnant, planning to become pregnant in the next 3 months, or breastfeeding
• 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.
• Consume more than 2 (two) alcoholic drinks per day.
• Cannabis or nicotine use that is weekly or more frequent.

• Age between 18-65 years old, inclusive
• Has self-reported moderate to severe gastrointestinal or digestive symptoms, such as abdominal pain, bloating, flatulence, constipation, or diarrhea.
• Has a Gastrointestinal Symptom Rating Scale (GSRS) score between 4-7.
• Has a Body Mass Index (BMI) \>27 but \<35.0 kg/m\^2.
• 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 and use at-home refrigerator and/or freezer.
• Able to complete study assessments including two stool sample collections, two blood sample collections, two intestinal permeability urine tests, and a food diary over the course of up to 12 weeks.