Early Phase 1 Ovarian Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are able to understand and willing to sign a consent form — or, for those who do not speak English, people who are able to have the consent form translated into their native language and have a translator present during the consent process
• People who are 18 years of age or older
• People who have been diagnosed with advanced (stage II, III, or IV) or returning ovarian cancer, and whose doctor has planned for them to receive a platinum-based chemotherapy treatment (containing cisplatin or carboplatin) as part of their standard care
• People who are willing to take part in all research activities outlined in the study
• People who are willing to avoid taking any other probiotic or prebiotic supplements (other than those provided by the study) for the duration of the study
• People who are willing to avoid making major changes to their diet throughout the study period
• People who have had a surgical opening created in the abdomen for waste removal (such as an ileostomy or colostomy) are permitted to take part

Who may not be able to join:

• People who have a type of ovarian tumour classified as "borderline" (not fully cancerous)
• People who have a known allergy or intolerance to any probiotic product
• People with a history of ongoing inflammation or a structural problem in the digestive tract, such as inflammatory bowel disease requiring medication, an active stomach or duodenal ulcer, a complete blockage of the small or large bowel, or an active abnormal channel (fistula) in the digestive tract
• People whose blood test results do not meet the levels required to safely receive platinum-based chemotherapy — for example, a white blood cell count (specifically neutrophils) that is too low
• People with a known allergic reaction to any ingredient in the study product, which includes specific bacterial strains (Akkermansia muciniphila, Anaerobutyricum hallii, Clostridium beijerinckii, Clostridium butyricum, and Bifidobacterium infantis), as well as chicory inulin, magnesium stearate, grape food colouring, and silica
• People with known allergic reactions to more than four of the following antibiotics, which are used against certain bacteria in the study product: penicillin, piperacillin, tetracycline, amoxicillin, and ampicillin (confirm with trial site)
• People with known allergic reactions to more than four of the following antibiotics, which are used against another bacterial strain in the study product: gentamicin, kanamycin, streptomycin, tetracycline, erythromycin, clindamycin, ampicillin, and vancomycin (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.