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


Trial ID: NCT04742907


This multicenter, randomized, double-blinded, placebo-controlled study will evaluate the effect of TU-100 on resolution of postoperative ileus (POI) in subjects undergoing open or laparoscopic bowel resection (BR).

Official Title

Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery After Surgery (ERAS) Protocol in Subjects Undergoing Bowel Resection

Stanford Investigator(s)

Sherry M. Wren, MD, FACS, FCS(ECSA), FISS
Sherry M. Wren, MD, FACS, FCS(ECSA), FISS

Professor of Surgery (General Surgery)


Inclusion Criteria:

   1. Male or female ≥ 18 years of age

   2. Women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP; must
   be able and willing to use at least 1 highly effective method of contraception during
   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 study
   program, 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, distal
   pancreatectomy, pancreaticoduodenectomy, gastric resection, uterine resection), or
   concomitant 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 the
   opinion of the investigator might confound the study results or pose additional risk
   in administering the study procedures

   5. Have a functional colostomy or ileostomy

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

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

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

   9. Chronic pain syndrome unrelated to the planned surgery requiring consistent management
   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 other
   immunosuppressive agent within 2 weeks of surgery or from immunosuppressive disease

14. Pregnant (identified by a positive serum pregnancy test) or lactating, or are not
   postmenopausal (no menses for at least 1 year) and are of childbearing potential and
   not using an accepted method of birth control (surgical sterilization, intrauterine
   contraceptive device, oral contraceptive, diaphragm, or condom in combination with
   contraceptive 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 medical
   device study, or any study in which active subject participation is required outside
   routine hospital data collection during the course of the study

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

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

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

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

20. Unwilling or unable to comply with procedures described in this protocol or is
   otherwise 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 the
   study results or pose additional risk in administering the study procedures


drug: TU-100

drug: Placebo


Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305