Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery After Surgery in Subjects Undergoing Bowel Resection

Inclusion Criteria:

1. Male or female ≥ 18 years of age

2. Women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP; mustbe able and willing to use at least 1 highly effective method of contraceptionduring the study and for 30 days after the last dose of study drug

3. American Society of Anesthesiologists Physical Status Score of 1 to 3

4. Scheduled for an elective BR via open or laparoscopic approach

5. Ability to understand the study procedures, have agreed to participate in the studyprogram, and have voluntarily provided informed consent

Exclusion Criteria:

1. Scheduled for a BR that is not listed in this protocol

2. Requires any additional resections beyond the intestine (eg, hepatectomy, distalpancreatectomy, pancreaticoduodenectomy, gastric resection, uterine resection), orconcomitant surgeries (with the exception of biopsies)

3. Requires the formation of a stoma (ileostomy or colostomy)

4. History of surgeries, illness, or behavior (eg, depression, psychosis) that in theopinion of the investigator might confound the study results or pose additional riskin administering the study procedures

5. Have a functional colostomy or ileostomy

6. Diagnosed with advanced or metastatic colon cancer (Stage IV by tumor, node, andmetastasis classification)

7. Positive coronavirus disease 2019 (COVID-19) test

8. Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection (including human immunodeficiency virus (HIV)), diabetes, symptomaticcongestive heart failure and ejection fraction < 35%, unstable angina pectoris,cardiac arrhythmia, or psychiatric illness/social situations that would limitcompliance with protocol requirements

9. Chronic pain syndrome unrelated to the planned surgery requiring consistentmanagement with analgesics and/or other non-pharmacologic modalities

10. Myocardial infarction within 3 months

11. Corrected QT interval > 500 msec

12. Diabetic gastroparesis

13. Compromised immune system, either from treatment with corticosteroids or otherimmunosuppressive agent within 2 weeks of surgery or from immunosuppressive disease (HIV)

14. Pregnant (identified by a positive serum pregnancy test) or lactating, or are notpostmenopausal (no menses for at least 1 year) and are of childbearing potential andnot using an accepted method of birth control (surgical sterilization, intrauterinecontraceptive device, oral contraceptive, diaphragm, or condom in combination withcontraceptive cream, jelly, or foam or abstinence)

15. Participated in another investigational drug/biologic or medical device study within 30 days of surgery or will be enrolled in another investigational drug or medicaldevice study, or any study in which active subject participation is required outsideroutine hospital data collection during the course of the study

16. Illicit drug use or alcohol abuse based on medical history, or currently engaged inillicit drug use or alcohol abuse

17. Uses of supplemental ginger, ginseng, or Zanthoxylum fruit within 72 hours beforerandomization

18. Has a history of allergic reactions to ginseng, ginger, Zanthoxylum fruit, orlactose

19. Has clinical symptoms of lactose intolerance after ingesting milk or milk-containingproducts (abdominal pain, flatulence, diarrhea)

20. Unwilling or unable to comply with procedures described in this protocol or isotherwise unacceptable for enrollment in the opinion of the investigator

21. Has a history of previous surgeries, illness (interstitial pneumonia), or behavior (depression, psychosis) that, in the opinion of the investigator, might confound thestudy results or pose additional risk in administering the study procedures