NCT07336615
A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Impact of CLB101TM️ on Gut Health in Healthy, Overweight Individuals
Enrolling by Invitation
NAAges 18–65InterventionalSupportive careClostraBio Inc.
~48 participants
Updated 2026-03-23 on ClinicalTrials.gov
What's tested:CLB101™️PlaceboPlacebo control
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Events
Measured over 6 weeks
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Naoh Craft, MD · PRINCIPAL_INVESTIGATOR · People Science, Inc.
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
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
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.
What this trial measures
- Adverse Events6 weeks
The primary outcome measure is to observe the safety and tolerability of the study product. Assessment of the number, frequency, and severity of adverse events (AEs), serious adverse events (SAEs) and AE withdrawals reported over the study product/placebo use period.