Modulation of the Gut Microbiome for Cancer Therapy

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 24

Inclusion Criteria

• Willing and able to provide written informed consent/assent for the trial
• Confirmed diagnosis of stage I-IV CRC by histology
• Have adequate organ function in the opinion of the investigator
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Toxicity from prior cancer therapy should have been resolved to CTCAE Grade = 1 (excluding alopecia and neuropathy, where up to Grade 2 residual is allowed for up to 6 weeks after end of chemotherapy)
• Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR - Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days corresponding to the time needed to eliminate any study intervention(s) after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. - A WOCBP must have a negative highly sensitive serum pregnancy test at screening visit and thus before the first dose of study intervention. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
• Stage IV patients will have to present a thoracoabdominal CT scan (TACT) or PET-CT scan as well as liver MRI at screening visit that is not older than 6 weeks (performed as part of the regular medical treatment at the end of the adjuvant chemotherapy) as per clinical routine as part of their regular medical treatment according to USZ (ESMO-based) treatment guidelines.
• Stage IV patients will have a TACT, PET-CT and/or liver MRI as per clinical routine as part of their regular medical treatment according to USZ (ESMO-based) treatment guidelines

Exclusion Criteria

• Subjects treated with chemotherapy, immunotherapy, biologic therapy, or other investigational agent within <28 days of starting study product. Continuation of hormone replacement therapy is permitted. Stable regimens of hormonal therapy i.e. for prostate cancer (e.g. leuprolide, a GnRH agonist), ovarian, or breast cancer are not exclusionary.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant’s participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
• Active bacterial infection requiring oral or systemic antibiotic therapy
• Subjects who have completed a course of antibiotics within four weeks prior to first dosing
• Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the trial
• Any medical condition of health disorders that prevents from participating the clinical trial in the opinion of the investigators
• Known HIV infection, or active infection with hepatitis B or C
• Any disease or syndrome causing immunodeficiency in the opinion of the treating investigator
• Additional hematologic or lymphatic malignancies within the last 2 years
• Any disease requiring immunosuppressive or immunomodulatory treatment which makes the patient inapplicably for a participation in the trial in the opinion of the investigator
• Female subjects that are pregnant or breastfeeding
• ECOG status 2-4

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demonstrate a persistent modification of the intestinal microbiome in the feces (stool) of the participants following Bacteria administration as measured by metagenomics analysis by Shotgun Sequencing. Analyses are performed at the beginning of the study, after 8 weeks and at the end of the study after 24 weeks.

Secondary Outcome Measures