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

NCT07336615

CompletedNA

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (1)
  • Los Angeles, California, United States