Delay in GI Recovery/Postoperative Ileus (POI)Phase 2NCT07765589

TU-100 for Accelerating GI Recovery After Major Abdominopelvic Surgery (RC & CAWR)

A Phase 2 study testing TU-100 in people with Delay in GI Recovery/Postoperative Ileus (POI), run by Tsumura USA.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Delay in GI Recovery/Postoperative Ileus (POI)
What is being tested?: TU-100
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 240 participants
Where: No sites listed yet
Study dates: Dec 2026to Jul 2028
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female participants aged 18 years or older
American Society of Anesthesiologists (ASA) Physical Status Classification I-III
Scheduled to undergo elective open or minimally invasive Radical Cystectomy (RC) with continent or incontinent urinary diversion requiring bowel resection, or open or complex minimally invasive surgery for Complex Abdominal Wall Reconstruction (CAWR) with anticipated myofascial advancement flap and mesh placement for moderate or giant hernia defects
Body mass index (BMI) ≤40 kg/m²
Women of childbearing potential and men with partners of childbearing potential must agree to use highly effective contraception
Willing and able to comply with study procedures and able to voluntarily provide informed consent

Who cannot join

Not scheduled for a Radical Cystectomy (RC) or Complex Abdominal Wall Reconstruction (CAWR) procedure meeting the inclusion criteria
Known gastric or bowel obstruction
Have had or have planned gastrectomy, gastric bypass, colostomy, or ileostomy
Significant gastrointestinal motility disorders
Pregnancy or breastfeeding
Clinically significant hepatic, renal, cardiovascular, or other uncontrolled medical conditions
Immunocompromised state or recent immunosuppressive therapy

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Tomoyuki Hashiguchi, Director, Clinical Development contact

609-799-2093

hashiguchi_tomoyuki@mail.tsumura.co.jp

About this study

Official title: Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of TU-100, Adjunctive to an Enhanced Recovery After Surgery (ERAS) Pathway, to Accelerate Gastrointestinal Recovery in Subjects Undergoing Major Abdominopelvic Surgery (Radical Cystectomy [RC] and Complex Abdominal Wall Reconstruction [CAWR])

This Phase 2, multicenter, randomized, double-blind, placebo-controlled master protocol study will evaluate the safety and efficacy of TU-100, adjunctive to an Enhanced Recovery After Surgery (ERAS) pathway, for accelerating gastrointestinal recovery following major abdominopelvic surgery. TU-100 will be evaluated in 2 surgical populations under a Master Protocol: 1. Subjects undergoing Radical Cystectomy (RC), 2.subjects undergoing Complex Abdominal Wall Reconstruction (CAWR).

Read the detailed description

Subjects will be screened for eligibility up to 28 days before their planned RC or CAWR surgery and will be randomized 1:1 (TU-100 7.5 g/day: placebo) on postoperative Day 1 before the first dose of study medication. After randomization, subjects will receive TU-100 7.5 g/day or matching placebo (3 times per day (TID)) until hospital discharge or ≤ 10 days (whichever is earlier). All subjects will be treated with study medication as adjunctive to an Enhanced Recovery After Surgery (ERAS) pathway for gastrointestinal recovery. The primary objective of the study is to compare the effect of TU-100 with placebo, in conjunction with and ERAS pathway, on the proportion of subjects achieving confirmed upper and lower GI recovery (GIR) following major abdominopelvic surgery requiring extensive manipulation and/or resection of the bowel.

Conditions: Delay in GI Recovery/Postoperative Ileus (POI)
Being tested: TU-100, Placebo
Keywords: TU-100, Daikenchuto, Kampo Medicine, Enhanced Recovery After Surgery, ERAS, Postoperative Ileus, Gastrointestinal Recovery, Radical Cystectomy, Complex Abdominal Wall Reconstruction, Abdominal Surgery, Major Abdominopelvic Surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TU-100Drug
TU-100 is a traditional Japanese herbal medicine consisting of processed ginger, ginseng, and Japanese pepper (Zanthoxylum fruit). Participants will receive 7.5 g/day orally administered as 2.5 g three times daily.
PlaceboDrug
Matching placebo granules similar in appearance to TU-100 and administered orally three times daily.

Study groups in NCT07765589
Study group	Role	What they receive
TU-100 7.5 g/day	Experimental	Subjects will receive a daily dose of TU-100 7.5 g (2.5 g TID) until hospital discharge or ≤ 10 days after surgery(whichever is earlier). Receives: Drug: TU-100
Placebo	Placebo comparator	Subjects will receive placebo TID until hospital discharge or ≤ 10 days after surgery (whichever is earlier). Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Confirmed Gastrointestinal Recovery (GIR) Response by postoperative day (POD) 3
Proportion of subjects achieving gastrointestinal recovery ([first toleration of solids] and [first spontaneous bowel movement or 1st consistent flatus]; GIR) by POD 3 without a subsequent serious adverse event (SAE) of primary POI.
Measured: Postoperative Day 3

Secondary outcomes (15)

Confirmed GI-2 Recovery Response by POD 4
Proportion of subjects achieving first toleration of solids and first spontaneous bowel movement (GI-2 recovery) by POD 4 without a subsequent SAE of primary POI.
Measured: Postoperative Day 4
Time to Gastrointestinal Recovery (GIR)
Time from the end of surgery to confirmed GIR, defined as first toleration of solid food and first spontaneous bowel movement or first consistent flatus.
Measured: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first
Proportion of subjects who achieve confirmed GIR by each postoperative day
Percentage of subjects achieving confirmed GIR, defined as first toleration of solid food and first spontaneous bowel movement or first consistent flatus, without a subsequent SAE of primary POI.
Measured: Postoperative Days 1-10
Time to GI-2 Recovery
Time from the end of surgery to GI-2 recovery, defined as first toleration of solid food and first spontaneous bowel movement.
Measured: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first
Proportion of subjects who achieve GI-2 recovery by each postoperative day
Percentage of subjects achieving GI-2 recovery, defined as first toleration of solid food and first spontaneous bowel movement.
Measured: Postoperative Days 1-10
Length of Hospital Stay
Length of hospital stay measured as the number of calendar days from the day of surgery to the date of hospital discharge.
Measured: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first
Occurrence of Nausea, Vomiting and/or Retching, and Abdominal Bloating
Proportion of subjects reporting nausea, vomiting and/or retching, and abdominal bloating during postoperative recovery. Data will be collected using subject-reported assessments and summarized by postoperative day.
Measured: Postoperative Days 1-10
Bothersomeness of Nausea and Abdominal Bloating
Subject-reported bothersomeness of nausea and abdominal bloating (24-hour reflection) during postoperative recovery. Data will be collected using subject-reported assessments and summarized by postoperative day. Bothersomeness is measured on a 0-10 point scale with 10 being the most bothersome.
Measured: Postoperative Days 1-10
Average of Abdominal Pain
Subject-reported abdominal pain (24-hour reflection) during postoperative recovery. Data will be collected using subject-reported assessments and summarized by postoperative day. Average abdominal pain will be reported on a 11-point Numeric Pain Rating Scale (NPRS), with 0 being no pain and 10 being worst pain imaginable.
Measured: Postoperative Days 1-10
Time to ready for discharge
Time from the end of surgery to readiness for discharge, based solely on GI recovery.
Measured: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first
Time to discharge order written
Time from the end of surgery to discharge order entry.
Measured: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first
Time to actual hospital discharge
Time from the end of surgery to actual hospital discharge.
Measured: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first
Time to first consistent flatus
Time from the end of surgery to first consistent flatus.
Measured: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first
Time to First Spontaneous Bowel Movement
Time from the end of surgery to the first spontaneous bowel movement.
Measured: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first
Time to Toleration of Solid Food
Time from the end of surgery to the first toleration of solid food without clinically significant intolerance requiring cessation of oral intake.
Measured: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2026Jul 2028

First posted14 Aug 2026
Study startDec 2026 (estimated)
Primary completionJun 2028 (estimated)
Study completionJul 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Delay in GI Recovery/Postoperative Ileus (POI)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This Phase 2 multicenter master protocol consists of two parallel sub-studies in subjects undergoing Radical Cystectomy (RC) or Complex Abdominal Wall Reconstruction (CAWR). Within each sub-study, eligible participants will be randomized 1:1 on postoperative Day 1 to receive TU-100 7.5 g/day or matching placebo. Aanalyses will be performed for each sub-study individually and for key outcomes for the pooled sub-studies.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 240 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07765589
Sponsor's protocol ID: TU100P2T5
Status last verified: Aug 2026
First submitted: 6 Aug 2026
Last updated: 14 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of TU-100, Adjunctive to an Enhanced Recovery After Surgery (ERAS) Pathway, to Accelerate Gastrointestinal Recovery in Subjects Undergoing Major Abdominopelvic Surgery (Radical Cystectomy [RC] and Complex Abdominal Wall Reconstruction [CAWR])
ClinicalTrials.gov ID: NCT07765589
Acronym / sponsor ID: TU100P2T5
Conditions: Delay in GI Recovery/Postoperative Ileus (POI)
Keywords: TU-100, Daikenchuto, Kampo Medicine, Enhanced Recovery After Surgery, ERAS, Postoperative Ileus, Gastrointestinal Recovery, Radical Cystectomy
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 240 participants (estimated)
Lead sponsor: Tsumura USAIndustry (pharma, biotech, devices)
Study start: Dec 2026 (estimated)
Primary completion: Jun 2028 (estimated)
Study completion: Jul 2028 (estimated)
First posted: 14 Aug 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: This Phase 2 multicenter master protocol consists of two parallel sub-studies in subjects undergoing Radical Cystectomy (RC) or Complex Abdominal Wall Reconstruction (CAWR). Within each sub-study, eligible participants will be randomized 1:1 on postoperative Day 1 to receive TU-100 7.5 g/day or matching placebo. Aanalyses will be performed for each sub-study individually and for key outcomes for the pooled sub-studies.

Arm	Type	Receives
TU-100 7.5 g/day	Experimental	Drug: TU-100Subjects will receive a daily dose of TU-100 7.5 g (2.5 g TID) until hospital discharge or ≤ 10 days after surgery(whichever is earlier).
Placebo	Placebo comparator	Drug: PlaceboSubjects will receive placebo TID until hospital discharge or ≤ 10 days after surgery (whichever is earlier).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Male or female participants aged 18 years or older
American Society of Anesthesiologists (ASA) Physical Status Classification I-III
Scheduled to undergo elective open or minimally invasive Radical Cystectomy (RC) with continent or incontinent urinary diversion requiring bowel resection, or open or complex minimally invasive surgery for Complex Abdominal Wall Reconstruction (CAWR) with anticipated myofascial advancement flap and mesh placement for moderate or giant hernia defects
Body mass index (BMI) ≤40 kg/m²
Women of childbearing potential and men with partners of childbearing potential must agree to use highly effective contraception

Key exclusion criteria (7 listed)

Not scheduled for a Radical Cystectomy (RC) or Complex Abdominal Wall Reconstruction (CAWR) procedure meeting the inclusion criteria
Known gastric or bowel obstruction
Have had or have planned gastrectomy, gastric bypass, colostomy, or ileostomy
Significant gastrointestinal motility disorders
Pregnancy or breastfeeding

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TU-100TU-100 is a traditional Japanese herbal medicine consisting of processed ginger, ginseng, and Japanese pepper (Zanthoxylum fruit). Participants will receive 7.5 g/day orally administered as 2.5 g three times daily.	Drug	TU-100 7.5 g/day
PlaceboMatching placebo granules similar in appearance to TU-100 and administered orally three times daily.	Drug	Placebo

Primary outcome

Confirmed Gastrointestinal Recovery (GIR) Response by postoperative day (POD) 3
Time frame: Postoperative Day 3
Proportion of subjects achieving gastrointestinal recovery ([first toleration of solids] and [first spontaneous bowel movement or 1st consistent flatus]; GIR) by POD 3 without a subsequent serious adverse event (SAE) of primary POI.

15 secondary outcomes

Confirmed GI-2 Recovery Response by POD 4
Time frame: Postoperative Day 4
Time to Gastrointestinal Recovery (GIR)
Time frame: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first
Proportion of subjects who achieve confirmed GIR by each postoperative day
Time frame: Postoperative Days 1-10
Time to GI-2 Recovery
Time frame: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first
Proportion of subjects who achieve GI-2 recovery by each postoperative day
Time frame: Postoperative Days 1-10
Length of Hospital Stay
Time frame: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first
Occurrence of Nausea, Vomiting and/or Retching, and Abdominal Bloating
Time frame: Postoperative Days 1-10
Bothersomeness of Nausea and Abdominal Bloating
Time frame: Postoperative Days 1-10
Average of Abdominal Pain
Time frame: Postoperative Days 1-10
Time to ready for discharge
Time frame: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first
Time to discharge order written
Time frame: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first
Time to actual hospital discharge
Time frame: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first
Time to first consistent flatus
Time frame: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first
Time to First Spontaneous Bowel Movement
Time frame: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first
Time to Toleration of Solid Food
Time frame: From the day of surgery (Day -1) through hospital discharge or Day 10, whichever occurs first

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Tomoyuki Hashiguchi, Director, Clinical Development contact

609-799-2093

hashiguchi_tomoyuki@mail.tsumura.co.jp

Tomoyuki Hashiguchi, Director, Clinical Development study director

Tsumura USA

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TU-100 in people with Delay in GI Recovery/Postoperative Ileus (POI), run by Tsumura USA.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tomoyuki Hashiguchi, Director, Clinical Development (609-799-2093, hashiguchi_tomoyuki@mail.tsumura.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed Gastrointestinal Recovery (GIR) Response by postoperative day (POD) 3 (time frame: Postoperative Day 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07765589.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.