Gut feeling: new probiotic trial aims to soothe stomach troubles
NCT ID NCT07423897
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a probiotic supplement called Bifidobacterium pseudocatenulatum ED02 in 35 adults to see if it safely improves gut health. Participants take either the probiotic or a placebo for a period, and researchers track side effects and changes in digestive symptoms. The goal is to see if this friendly bacteria can ease gastrointestinal discomfort.
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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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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- 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 years and older
- 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 18 years and older, inclusive. * 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. * Able to complete study assessments over the course of up to 15 weeks. Exclusion Criteria: Any potential participants who: * Do not have a personal smartphone, internet access, or unwilling to download Chloe. * Currently on a carnivore diet, raw food diet, fruitarian, liquid diet (does not include vegans or vegetarians). * Plan to make major changes in their diet during the study period. * Are not willing to complete stool samples. * Concomitant Therapies: 1. Participants receiving any investigational therapies or treatments within 30 days prior to randomization. 2. Participants currently taking or have taken antibiotics, probiotic, or prebiotic supplements within the past 4 weeks prior to randomization. 3. Participants using immunomodulating supplements, immunosuppressive medications, systemic steroids, antifungals or other medications known to significantly impact gastrointestinal function or microbiota. 4. Participants currently taking fiber supplements 5. Participants currently taking laxatives 6. Participants taking chronic NSAIDs 7. Participants taking Metformin * Other Illnesses or Conditions: Participants who have the following comorbidities or gastrointestinal illnesses are excluded: 1. 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) 2. Participants with a known or suspected gastrointestinal infection, such as: * Clostridium difficile infection * Helicobacter pylori infection * Parasitic infections (e.g., Giardia, Cryptosporidium) 3. Participants with a history of gastrointestinal bleeding or perforation. 4. Participants with autoimmune conditions, such as: * Lupus * Multiple sclerosis * Rheumatoid Arthritis 5. Participants with an immunocompromised status. 6. Participants with uncontrolled diabetes. 7. Participants with a history of gastrointestinal surgery, excluding appendectomy and cholecystectomy. 8. Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder. 9. Currently pregnant, planning to become pregnant in the next 3 months, or breastfeeding. 10. Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes. 11. 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 microcrystalline cellulose, magnesium stearate, or silicon dioxide. * 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.
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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, Inc.
Los Angeles, California, 90045, United States
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Other studies related to the condition(s) this trial covers.
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