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Sponsor: ClostraBio Inc.
Conditions: Gastrointestinal, Overweight , Obesity
Interventions: CLB101™️, Placebo, CLB101™️, Placebo control
Countries: United States
Anaerostipes caccae CLB101TM️ is a next-generation probiotic isolated from healthy humans. It was shown to be in decreased abundance in people with protein-based food sensitivities/allergies. CLB101TM️ is different from most commercially available probiotics in that it directly produces butyrate. Butyrate is a naturally occurring small molecule found in the gut of healthy individuals, and it has been shown to provide clinical benefits including strengthening the gut lining, providing immune health, and supporting a balanced microbiome. The rationale for developing CLB101TM️ is to provide a probiotic that generates butyrate in the targeted intestinal locations where it can optimally benefit cells that line the gut.
Sex: ALL
Age: 18 Years to 65 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria: * 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. Exclusion Criteria: * Participants that do not have a personal smartphone, internet access, or unwilling to download Chloe. * 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. * 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 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. * 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 probiotics, microcrystalline cellulose, vegetarian capsules, silica, or magnesium stearate. * 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.
- Los Angeles, California, United States