[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bactolife A\u002FS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100641080","safety-and-user-experience-of-bp-cbb-100641080",false,"NCT07628608","Safety and User Experience of BP-CBB","A Placebo-controlled, Double-blind, Safety and Experience Evaluation of IgG Binding Protein CBB (BP-CBB)","Inclusion Criteria:\n\n1. Be able to give written informed consent.\n2. Be between 18-65 years, both inclusive.\n3. Record greater than 3 bowel movements recorded during the one-week run-in period.\n4. In general, in good health, as determined by the investigator.\n5. Willing to consume the Study Product once daily for the duration of the study.\n6. Willing to avoid pro, pre post biotics and any new supplements for the duration of the study\n\nExclusion Criteria:\n\n1. Participants who are pregnant or wish to become pregnant during the study or who are lactating and\u002For currently breastfeeding.\n2. Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:\n\n   1. Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where Participant discontinues the study prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit).\n   2. Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant.\n   3. Sexual partner(s) is\u002Fare exclusively female.\n   4. Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, or contraceptive pill. The Participant must be using this method for at least one week prior to and one week following the end of the study.\n   5. Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least two weeks prior to the first screening visit, throughout the study, and two weeks following the end of the study.\n3. Has a history of drug and\u002For alcohol abuse.\n4. Has known food allergies, history of Type I (IgE-mediated) food allergies, or hypersensitivity or other issues with foods or ingredients that would preclude intake of the Study Product (i.e. soya).\n5. Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include:\n\n   1. Diagnosed gastrointestinal conditions\n   2. Previous bariatric surgery\n   3. Immunocompromised health conditions\n6. Current or recent use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:\n\n   1. Systemic antibiotics - in the 4 weeks prior to Visit 1\n   2. Proton pump inhibitors (PPIs) - in the past 4 prior to Visit 1\n   3. Non-steroidal anti-inflammatory drugs (NSAIDs) - in the past 2 weeks prior to Visit 1\n   4. GLP-1 agonists - in the 12 weeks prior to Visit 1\n   5. SGLT-2 inhibitors - in the 12 weeks prior to Visit 1\n7. Current or recent (in the 4-weeks prior to Visit 1) use of prohibited nutritional or non-nutritional supplements that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited supplements include:\n\n   1. Probiotics\n   2. Prebiotics\n   3. Synbiotics\n   4. Postbiotics\n8. Regular (weekly) consumption of fermented food products (e.g. kefir, kombucha)\n9. Planning to make significant dietary or lifestyle changes during the study period (e.g., travel, exercise, diet, change in body weight).\n10. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.\n11. Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.",true,"ALL","18 Years","65 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study is the first-in human study for the food ingredient BP-CBB and aims aims to build on the excellent safety and tolerability observed in the extensive food safety assessment performed for BP-CBB, as well as the consumer experience with using the product, and to set the scene for future human studies documenting the health-benefits of daily supplementation with BP-CBB for diverse populations.",[28],"Safety and Tolerability in Healthy Volunteers",[30,31,32,33,34,35],"healthy volunteer","first-in-human","binding protein","safety","Tolerability","User experience","RECRUITING","2026-06-17",{"date":39,"type":40},"2026-06-18","ACTUAL",{"date":42,"type":40},"2026-06-16",{"date":44,"type":22},"2026-12-01",{"name":46,"class":47},"Bactolife A\u002FS","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100612218","c-difficile-toxin-levels-in-stool-from-healthy-individuals-following-standard-of-care-antibiotic-treatment-for-cdi-100612218","NCT07250724","C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.","A Prospective, Observational Study to Evaluate C. Difficile Toxin Levels in Stool in Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.","Participants will be included in the study if they meet all of the following criteria\n\nAt the time of screening:\n\n* Able to provide signed and dated informed consent\n* Males and females from the age of 18 and above\n* Planned or already ongoing SoC antibiotic treatment for diagnosed Clostridiodides difficile infection (CDI). All types of diagnosis\u002Ftesting algorithms, and antibiotic taper regimes acceptable.\n* Documented history of, minimum one previous CDI episode occurring within the last 12 months.\n\nAt the Time of Baseline Visit:\n\n\\- Have completed the antibiotic treatment regime for the current CDI, a maximum of 5 days prior to the baseline visit\n\nExclusion criteria\n\nParticipants will be excluded from the study if they meet any of the following criteria:\n\nAt the time of screening:\n\n* Planned CDI recurrence treatment for the planned 8-week duration of study participation (I.e., Fecal microbiome transplant, Rebyota, Vowst, Live Biotherapeutic Products (LBPs), probiotics etc)\n* Pregnant or lactating women or women who intend\u002Fwish to become pregnant in the time period in between screening and visit 4\n* Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. I.e.: Ostomized participants, Parenteral nutrition users, Patients with active Pancreatitis, Active, non-controlled intestinal diseases such as IBS, IBD, Crohn's Disease, ulcerative colitis, celiac disease, or other chronic diarrheal illness\n* Currently or recently taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results.\n* Individuals who, in the opinion of the investigator, are considered to be poor study attendees or unlikely for any reason to be able to comply with the study.\n* Participants may not be participating in other clinical studies, or planning to do so during participating in the present study. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.\n\nAt the time of baseline visit:\n\n* Lack of CDI symptom resolution following the SoC antibiotic regime. I.e. still active diarrhoea (3 or more stools per 24-hour period) and within Bristol stool scale range of 5-7 at baseline.\n* Those who are on, or during study participation plan to go on, antibiotic treatment for any reason.",{"count":21,"type":22},"OBSERVATIONAL","Hospitals and clinics interested in participating in this multi-site study, please contact the people mentioned under \"Contacts and Locations\".\n\nThe goal of this study is to map the risk of having a C. Difficile infection recurrence (rCDI) after being treated with standard-of-care antibiotics for a C. Difficile infection.\n\nThe main questions it aims to answer are:\n\n* What is the recurrence rate of CDI in the 8 weeks following antibiotic treatment for a first recurrence of CDI?\n* Does toxin levels of Toxin A and\u002For B from C. Diff. at baseline predict CDI recurrence risk?\n\nParticipants will:\n\n* Undergo standard of care Antibiotic treatment for first recurrence of CDI\n* Visit their clinic at 4 different visits over a time period of approximately 9 weeks. (Visits can also be performed remote\u002Fvia phone call.)",[60],"Clostridioides Difficile Infection Recurrence",[62,63,64,60,65,66],"C. Diff","Clostridioides Difficile","Clostridioides Difficile Infection","Clostridioides Difficile Recurrence","C. Diff recurrence","2026-06-12",{"date":69,"type":40},"2026-06-15",{"date":71,"type":40},"2026-03-01",{"date":73,"type":22},"2026-10-15",{"name":46,"class":47},4,""]