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Study Summary
This trial will test if TU-100 can help POI after surgery. TU-100 will be compared to a placebo in those who had open or laparoscopic bowel resection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am not pregnant, breastfeeding, and if capable of becoming pregnant, I am using effective birth control.I need to have surgery to create an opening (stoma) for waste removal.I have not used ginger, ginseng, or Zanthoxylum fruit in the last 72 hours.I have a working colostomy or ileostomy.I don't have any health or behavioral issues that could risk the study.My colon cancer is advanced or has spread to other parts of my body.I am 18 years old or older.I am willing to use effective birth control during and 30 days after the study.I have slow stomach emptying due to diabetes.You have a history of using illegal drugs or abusing alcohol, or you are currently using illegal drugs or abusing alcohol.I have had a heart attack in the last 3 months.I need surgery beyond intestine surgery, like liver or stomach surgery.I understand the study and have agreed to participate willingly.I do not have any uncontrolled illnesses that could affect my participation.My immune system is weak due to recent treatments or a condition like HIV.My health is good to moderately impaired.I am scheduled for a bowel resection surgery, either open or with a camera.You have had allergic reactions to ginseng, ginger, Zanthoxylum fruit, or lactose in the past.I manage ongoing pain not related to surgery with medication or other treatments.I experience stomach pain, gas, or diarrhea after consuming dairy.
- Group 1: TU-100 15 g/day
- Group 2: TU-100 7.5 g/day
- Group 3: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is TU-100 a new experimental drug?
"As of now, there is only one trial studying the effects of TU-100. However, this research is still in operation and has not yet entered into Phase 3 testing. Additionally, even though most of the clinical trials for TU-100 are based out of Little Rock, Arkansas, there are a total 44 locations running these studies."
Could you please tell me the mortality rate of TU-100?
"TU-100's safety was given a score of 2 by our analysts because, while Phase 2 trials provide some evidence of safety, there is no data currently available to support efficacy."
What are the precedents for this type of research?
"TU-100 is only being studied in one active clinical trial across 37 locations in a single country. The first study of TU-100 was completed in 2021 and it reached Phase 2 approval. A total of 402 patients were involved in the study, which was sponsored by Tsumura USA. Since then, 18291 studies have been completed."
How many research facilities are conducting this trial?
"Presently, this study is recruiting patients from 42 different sites. Some of these locations are in Weston, Salt Lake City and Danbury with the other 39 cities being located elsewhere. If you are considering participating in this trial, it may be convenient to select a location nearest to you to limit travel requirements."
How many people will be enrolled in this clinical trial?
"The clinical trial is still open and actively recruiting patients, as of 11/10/2022. According to the information available on ClinicalTrials.gov, this study was first posted on 7/29/2021. They are looking for a total of 402 participants across 42 sites."
Are there any vacancies in this trial for new participants?
"Yes, the trial is still recruiting patients. The relevant information on clinicaltrials.gov indicates that the study was posted on 29 July 2021 and last updated 10 November 20202."
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