What side effects are associated with this type of intervention?

Common treatments in Enhanced Recovery After Surgery (ERAS) protocols that aim to enhance gastrointestinal motility and reduce inflammation include prokinetic agents like metoclopramide and erythromycin, as well as anti-inflammatory medications. Metoclopramide can cause side effects such as tardive dyskinesia, extrapyramidal symptoms, and drowsiness. Erythromycin, while effective in accelerating gastric emptying, can lead to gastrointestinal disturbances like nausea, vomiting, and abdominal pain. Anti-inflammatory medications, depending on their class, may cause gastrointestinal irritation, increased risk of bleeding, and renal impairment. TU-100 (Daikenchuto), being a traditional Japanese medicine, is generally well-tolerated but may cause mild gastrointestinal symptoms such as diarrhea or abdominal discomfort in some patients.

What prior FDA approvals exist?

FDA-approved treatments for Enhanced Recovery After Surgery (ERAS) that are similar to TU-100, which aims to enhance gastrointestinal motility and reduce inflammation, include medications like alvimopan and methylnaltrexone. Alvimopan is a peripherally acting mu-opioid receptor antagonist that helps accelerate the time to gastrointestinal recovery following surgeries that include bowel resection. Methylnaltrexone, another peripherally acting mu-opioid receptor antagonist, is used to treat opioid-induced constipation, which can be a component of postoperative ileus. Both drugs work by improving bowel motility, similar to the proposed effects of TU-100.

What other types of research exist?

Promising alternatives to TU-100 for ERAS patients include: 1) Erythromycin, which accelerates gastric emptying and has prokinetic effects. 2) Domperidone, which enhances gastrointestinal motility and is effective in treating gastroparesis. 3) Metoclopramide, which also promotes gastric emptying and reduces symptoms of gastroparesis. These alternatives have shown efficacy in enhancing gastrointestinal motility and could be considered for aiding in the resolution of postoperative ileus.

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TU-100 for Enhanced Postoperative Recovery

Phase 2

Waitlist Available

Research Sponsored by Tsumura USA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

American Society of Anesthesiologists Physical Status Score of 1 to 3

Scheduled for an elective BR via open or laparoscopic approach

Must not have

Requires the formation of a stoma (ileostomy or colostomy)

Chronic pain syndrome unrelated to the planned surgery requiring consistent management with analgesics and/or other non-pharmacologic modalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the day after surgery to discharge follow-up visit (30 days (+ 7 days) after hospital discharge)

Summary

This trial is testing TU-100, an herbal medicine, to see if it helps patients recover faster from bowel surgery. It targets patients who often have trouble with their intestines not working properly after surgery. The medicine may help by reducing inflammation and getting the intestines moving again. Daikenchuto (TU-100) is a traditional Japanese herbal medicine made from ginger, ginseng, and Japanese pepper, commonly used for various intestinal disorders and postoperative recovery.

Who is the study for?

Adults over 18, able to consent and follow study procedures, undergoing elective bowel resection surgery. They must use effective contraception if of childbearing potential. Excluded are those with recent heart attacks, certain surgeries or conditions that could affect results or pose risks, uncontrolled illnesses like severe heart failure or arrhythmias, compromised immune systems, pregnant or lactating women, and anyone using certain supplements.

What is being tested?

The trial is testing TU-100's effectiveness in speeding up recovery from postoperative ileus (delayed bowel function) after bowel resection surgery compared to a placebo. Participants will be randomly assigned to either the TU-100 group or the placebo group without knowing which one they receive.

What are the potential side effects?

Specific side effects aren't listed for TU-100; however, participants should report any unusual symptoms as they may relate to the intervention. Common surgical recovery issues may include pain at the incision site, nausea, constipation or diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My health is good to moderately impaired.

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I am scheduled for a bowel resection surgery, either open or with a camera.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need to have surgery to create an opening (stoma) for waste removal.

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I manage ongoing pain not related to surgery with medication or other treatments.

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I have slow stomach emptying due to diabetes.

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I experience stomach pain, gas, or diarrhea after consuming dairy.

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I need surgery beyond intestine surgery, like liver or stomach surgery.

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I have a working colostomy or ileostomy.

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My colon cancer is advanced or has spread to other parts of my body.

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I do not have any uncontrolled illnesses that could affect my participation.

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My immune system is weak due to recent treatments or a condition like HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the day after surgery to discharge follow-up visit (30 days (+ 7 days) after hospital discharge)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the day after surgery to discharge follow-up visit (30 days (+ 7 days) after hospital discharge)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the day after surgery to discharge follow-up visit (30 days (+ 7 days) after hospital discharge) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to gastrointestinal recovery (GIR)

Secondary study objectives

GIR outcome related to length of hospitalization

POI-related morbidity

Safety of TU-100

+1 more

Other study objectives

Effects of TU-100 on early postoperative surgical outcomes related to mechanism of action

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: TU-100 7.5 g/dayExperimental Treatment1 Intervention

Subjects will receive a total daily dose of TU-100 2.5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).

Group II: TU-100 15 g/dayExperimental Treatment1 Intervention

Subjects will receive a total daily dose of TU-100 5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).

Group III: PlaceboPlacebo Group1 Intervention

Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TU-100

2021

Completed Phase 2

~510

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Enhanced Recovery After Surgery (ERAS) protocols often include treatments aimed at improving gastrointestinal motility and reducing inflammation to expedite recovery. TU-100, a traditional Japanese medicine, enhances gastrointestinal motility and reduces inflammation, which can help resolve postoperative ileus—a common complication that delays recovery. By promoting bowel function and reducing inflammatory responses, treatments like TU-100 can significantly improve patient outcomes, reduce hospital stays, and enhance overall recovery in ERAS patients.