CompletedNot Applicable

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

United States85 participantsStarted 2025-10-09

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adverse Events

Timeframe: 6 weeks

Trial details

NCT IDNCT07336615

SponsorClostraBio Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-23

View on ClinicalTrials.gov More Gastrointestinal trials