RecruitingPhase 2NCT06436976

The Effect of Probiotics ATG-F4 in Cancer Patients


Sponsor

Chungnam National University Hospital

Enrollment

30 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Patients with advanced colorectal cancer or pancreatic cancer who are receiving oxaliplatin-based chemotherapy will be included. The research participants in this study will consume probiotics along with safety and anti-cancer agent side effect-related questionnaires, blood, and fecal sample collection for up to 12 weeks from the date of registration. The total duration of participation for research subjects is 12 weeks.


Eligibility

Min Age: 19 Years

Inclusion Criteria5

  • Patients diagnosed with advanced colorectal cancer or pancreatic cancer who are undergoing treatment with Oxaliplatin-based chemotherapy at Chungnam National University Hospital, including both newly diagnosed and recurrent cases.
  • Aged 19 years or older.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 points.
  • Expected life expectancy of at least 3 months.
  • Ability to understand the requirements of the clinical trial and willingness to sign the informed consent form.

Exclusion Criteria8

  • Presence of known brain metastases.
  • Malignant bowel obstruction requiring surgical intervention.
  • Uncontrolled, active infections, symptomatic congestive heart failure, unstable angina, cardiac arrhythmias, or any psychiatric/social conditions that may limit compliance with the study requirements.
  • Partial or complete intestinal obstruction.
  • Pregnant or lactating women.
  • Use of antibiotics, antifungals, or antiviral agents on more than one occasion within the past month.
  • Consumption of probiotics products or fermented milk more than twice within the past month.
  • Patients with neurological or psychiatric disorders.

Interventions

DRUGLT-002 (Lactobacillus reuteri ATG-F4

The group that will be consuming probiotics for 12 weeks.


Locations(1)

Chungnam National University Hospital

Daejeon, South Korea

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NCT06436976


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