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

Enrolling by invitation · Not applicable · Has a placebo group

Conditions studied: Gastrointestinal, Overweight , Obesity

In brief

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.

Key facts

Study ID

NCT07336615

Run by

ClostraBio Inc.

People needed

48

Starts

2025-10-09

Expected to finish

2026-06-26

Last updated by the study team

2026-03-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• People Science — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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