The Effect of Probiotics ATG-F4 in Cancer Patients

NCT06436976 | Recruiting Phase 2 DMC

• 1 other identifier: CNUH 2023-08-012
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer; Colon Cancer

Keywords

probiotics; pancreatic cancer; colon cancer

Outcome Measures

Primary Outcomes (1)

• Changes of Body weight (Kg)

  Body weight measured by Bio-electrical Impedance Analysis

  baseline, 4 weeks, 8 weeks

Secondary Outcomes (13)

• Lean body mass

  baseline, 4 weeks, 8 weeks

• Body mass index

  baseline, 4 weeks, 8 weeks

• C-reactive protein

  baseline, 4 weeks, 8 weeks

• Interleukin-6

  baseline, 4 weeks, 8 weeks

• Neutrophil to lymphocyte ratio

  baseline, 4 weeks, 8 weeks

Study Arms (1)

LT-002 (Lactobacillus reuteri ATG-F4) arm

EXPERIMENTAL

The group that will be consuming probiotics (LT-002 (Lactobacillus reuteri ATG-F4)) for 12 weeks. The subjects will take a daily intake of 4 x 10\^10 colony forming unit (CFU) of LT-002.

Drug: LT-002 (Lactobacillus reuteri ATG-F4

Interventions

LT-002 (Lactobacillus reuteri ATG-F4 DRUG

The group that will be consuming probiotics for 12 weeks.

LT-002 (Lactobacillus reuteri ATG-F4) arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chungnam National University Hospital: lead
• AtoGen Co. Ltd: collaborator

Study Sites (1)

Chungnam National University Hospital

Daejeon, 35015, South Korea

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Hyewon Ryu, Professor

  Department of Hematology Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyewon Ryu, Professor

CONTACT

82 + 42 280 6834; ryhw001@naver.com

Sora Kang, clinical professor

CONTACT

sorakang0515@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: May 31, 2024
• Study Start: March 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)