New probiotic aims to soothe tummy troubles in overweight adults
NCT ID NCT07336615
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times
Summary
This study is testing a new probiotic called CLB101TM in healthy but overweight adults who have digestive issues like bloating or stomach pain. The probiotic is designed to produce a natural substance called butyrate, which may help strengthen the gut lining and support immune health. The study will check if the probiotic is safe and if it improves gut symptoms compared to a placebo.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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85 people
The number who actually took part.
- Started
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Oct 2025
- Finished
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Jun 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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People Science
Los Angeles, California, 90034, United States
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Other studies related to the condition(s) this trial covers.
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