MS-20 on Gut Microbiota and Risk/Severity of Cachexia in Pancreatic Cancer Patients

Inclusion Criteria:

1. Male or female subjects aged between 20 and 75 years old.
2. Patients with histologically- or cytologically-confirmed unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) who plan to receive gemcitabine alone or in combination with other chemotherapeutic agents.
3. ECOG (Eastern Cooperative Oncology Group Performance status) scale between 0 and 2.
4. Female subjects of childbearing potential must use at least two forms of birth control. Subjects who are postmenopausal (defined as amenorrhea for 12 consecutive months) , surgically sterilized (ie, hysterectomy, bilateral oophorectomy, or bilateral tubal ligation), or have abnormalities of the reproductive tract will be considered as having no childbearing potential.
5. The subject is able to provide written informed consent by himself/herself and agrees to comply with all protocol requirements.
6. The subject agrees to comply with the following two requirements:

   1. comply with all follow-up visit requirements according to the trial protocol.
   2. comply with all requirement regarding fecal samples collection, storage and delivery according to the trial protocol.

Exclusion Criteria:

1. The subject has soybean allergy.
2. The subject is pregnant or lactating.
3. The subject has received or is receiving chemotherapy.
4. The subject has received any antibiotic, antifungals or antivirals (excluding topical agents and antiviral prophylaxis for hepatitis B virus) within 14 days prior to visit 2 (Day 1).
5. The subject has a clinically significant, currently active or underlying diarrhea (soft or loose stools more than three times in 24 hours) of infectious etiologies.
6. The subject has received any steroids, immunosuppressant or anti-inflammation drugs within 14 days prior to visit 2 (Day 1)..
7. The subject has received probiotics or prebiotics within 14 days prior to visit 2 (Day 1).
8. The subject has abnormal organ and bone marrow function as defined below:

   1. Patients with abnormal liver function tests (serum bilirubin level ≧ 2 times upper limit of normal (ULN), aspartate transaminase (AST) or alanine transaminase (ALT) ≧ 3.0 X ULN).
   2. Patients with renal disease or renal dysfunction (serum creatinine ≧ 1.5 X ULN) or estimated glomerular filtration rate (eGFR)\< 50 mL/min/1.73 m2.
9. The subject has active inflammatory bowel disease or gastric ulcer.
10. The subject currently is participating in studies involving other investigational drugs, medical devices, functional foods, or cosmetics.
11. The subject is considered by the investigator as not suitable for the trial.
12. The subject is judged by the investigator as not suitable for the trial due to concerns about possible non-compliance or severe concomitant illnesses.