Postbiotics for Colon Cancer Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how well a supplement called PoZibio balances gut bacteria after colon cancer surgery. Participants will take either the PoZibio gummy or a placebo (a look-alike with no active ingredients) daily for a set period before and after surgery. The trial seeks individuals newly diagnosed with nonmetastatic colon cancer who are scheduled for surgery soon. The goal is to determine if PoZibio can maintain a healthy gut environment post-operation. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance post-surgery recovery for future patients.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot be taking prebiotic, probiotic, or postbiotic supplements, and you should not have used antibiotics in the last 3 months.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that postbiotics like PoZibio are likely safe for use. Studies on similar supplements have found them to be generally well-tolerated, with no serious side effects reported. Some research on probiotics, which are similar to postbiotics, suggests they can help reduce post-surgery complications. This implies that PoZibio might also be safe and beneficial.
PoZibio is currently being tested in a trial without a specific phase, so detailed safety information is limited. However, its inclusion in trials suggests researchers consider it safe enough for human testing. Prospective participants might find this information reassuring regarding the treatment's safety.12345Why are researchers excited about this trial?
Unlike the standard treatments for colon cancer, which often involve chemotherapy or targeted therapies, PoZibio is a postbiotic that is administered as a chewable gummy. Researchers are excited about PoZibio because it offers a novel approach by supporting gut health through postbiotics, which are beneficial compounds produced by gut bacteria. This could potentially enhance recovery and reduce complications after surgery, making it a unique option compared to traditional treatments. Additionally, the convenient gummy form is easy to take, which might improve patient compliance.
What evidence suggests that PoZibio might be an effective treatment for gut dysbiosis after colon cancer surgery?
This trial will compare PoZibio with an inert placebo to evaluate its effects on gut health after colon cancer surgery. Research has shown that postbiotics, like PoZibio, can support gut health following such surgeries. Studies have found that postbiotics improve the balance of gut bacteria, which often becomes disrupted after surgery. Postbiotics maintain gut health similarly to probiotics. This balance is crucial for better recovery and overall health. Although specific data on PoZibio is limited, the general evidence for postbiotics in supporting gut health is promising.12678
Who Is on the Research Team?
Richard Jacobson, MD
Principal Investigator
University of South Florida
Are You a Good Fit for This Trial?
This trial is for individuals undergoing surgery for colon or colorectal cancer. Participants should be in stable condition to undergo the procedure and willing to take postbiotic supplements or a placebo afterward.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-surgery Treatment
Participants receive 1 gummy daily for at least 7 days prior to surgery
Post-surgery Treatment
Participants continue to receive 1 gummy daily for 90 days post surgery
Follow-up
Participants are monitored for changes in fecal SDI and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Inert placebo
- PoZibio
Trial Overview
The study tests if PoZibio, a postbiotic supplement, can help maintain healthy gut bacteria levels after colon cancer surgery compared to an inactive placebo. The focus is on changes in the fecal Shannon Diversity Index as a measure of gut health.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Treatment group will receive PoZibio at a dose of 1 gummy once daily for 7 days prior to surgery and 90 days post surgery. Pozibio will be administered as a chewable gummy formulation, to be taken orally at approximately the same time each day.
Control group will receive an inert placebo gummy, matched in appearance, taste, texture, and packaging to Pozibio®. The placebo will also be taken once daily for 7 days prior to surgery and 90 days post surgery, following the same schedule as the Test group.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of South Florida
Lead Sponsor
Citations
Postbiotics for Mitigation of Postoperative Dysbiosis in ...
Treatment group will receive PoZibio at a dose of 1 gummy once daily for 7 days prior to surgery and 90 days post surgery. Pozibio will be administered as a ...
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ctv.veeva.com
ctv.veeva.com/study/postbiotics-for-mitigation-of-postoperative-dysbiosis-in-colon-cancer-surgeryPostbiotics for Mitigation of Postoperative Dysbiosis in Colon ...
Treatment group will receive PoZibio at a dose of 1 gummy once daily for 7 days prior to surgery and 90 days post surgery. Pozibio will be ...
Postbiotics for Colon Cancer Surgery · Info for Participants
Trial Overview The study tests if PoZibio, a postbiotic supplement, can help maintain healthy gut bacteria levels after colon cancer surgery compared to an ...
Beneficial insights into postbiotics against colorectal cancer
In this review, we outline the current state of research toward the beneficial effects of gut microbiota derived postbiotics against CRC.
Comparison of the effects of postbiotics and live-probiotics ...
Evidence suggests that probiotics can be used as functional food to improve colorectal cancer (CRC) conditions. Postbiotics can provide the same benefits as ...
Effects of PrObiotics on the Symptoms and Surgical ...
We investigated microbiota changes following surgical colon cancer resection and evaluate effects of probiotics on microbiota and surgical ...
Perioperative or Postoperative Probiotics Reduce ...
Our findings suggest that perioperative or postoperative probiotics is effective for reducing treatment-related complications in patients with colorectal ...
Comparison of Probiotic Effects on the Outcomes ...
Comparison of Probiotic Effects on the Outcomes of Patients After Colorectal Cancer Surgery ... Baseline CRP data was collected on the same day the patient ...
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