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New treatment option for Short Bowel Syndrome
Official title A Clinical Study of FT1 in Patients With Short Bowel Syndrome
ClinicalTrials.gov ID: NCT07704047
What this study is testing
What is FT1?
FT1 is an investigational medicine, given as an once-weekly injectable medicine, being studied as a potential treatment for short bowel syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if FT1 is safe and works to treat short bowel syndrome (SBS) in adults. It will also learn about the PK/PD profile of FT1.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years, male or female.
- SBS secondary to surgical resection of the small intestine, screened for at least 12 months after pre intestinal resection surgery;
- Stable weight before screening; For patients requiring parenteral support (PS), PS volume remained stable (with changes in volume or energy...
- Willing to undergo colonoscopy and remove polyps assessed by researchers to be at risk of cancer;
- During the trial period, there were no plans to perform any major abdominal surgeries (such as intestinal resection exceeding 10% or surgeries that...
You likely can't join if
- Having undergone major abdominal surgery (such as intestinal resection exceeding 10%) within the past 6 months prior to screening;
- History of clinically significant intestinal adhesions and/or chronic abdominal pain;
- History of persistent radiation enteritis, celiac disease, refractory diarrhea, etc;
- Patients with malignant tumors within the past 5 years (excluding fully treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of...
- History of gallstones in the past 3 years, except for those who have undergone cholecystectomy for gallstones; Acute cholecystitis or biliary...
- IBD patients with active inflammatory bowel disease (IBD), or requiring increased or altered immunosuppressive therapy in the past 3 months, or...
See the full eligibility criteria
- Age ≥ 18 years, male or female.
- SBS secondary to surgical resection of the small intestine, screened for at least 12 months after pre intestinal resection surgery;
- Stable weight before screening; For patients requiring parenteral support (PS), PS volume remained stable (with changes in volume or energy content\<25%) within 14 days prior to randomization;
- Willing to undergo colonoscopy and remove polyps assessed by researchers to be at risk of cancer;
- During the trial period, there were no plans to perform any major abdominal surgeries (such as intestinal resection exceeding 10% or surgeries that alter intestinal anatomy, such as stoma surgery);
- During the baseline metabolic balance study, the average daily fecal wet rearrangement amount was ≥ 800g;
- Having undergone major abdominal surgery (such as intestinal resection exceeding 10%) within the past 6 months prior to screening;
- History of clinically significant intestinal adhesions and/or chronic abdominal pain;
- History of persistent radiation enteritis, celiac disease, refractory diarrhea, etc;
- Patients with malignant tumors within the past 5 years (excluding fully treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, local prostate cancer after radical surgery, and ductal...
- History of gallstones in the past 3 years, except for those who have undergone cholecystectomy for gallstones; Acute cholecystitis or biliary obstruction related diseases that have not been treated within the previous...
- IBD patients with active inflammatory bowel disease (IBD), or requiring increased or altered immunosuppressive therapy in the past 3 months, or receiving biologic therapy in the past 6 months;
- Occurrence of central venous catheter-related bloodstream infections within 2 months prior to and during the screening period;
- Patients diagnosed with decompensated heart failure (NYHA grade III or above) and/or unstable angina and/or myocardial infarction from 6 months prior to screening until the first administration of the study drug;
- Screening for individuals with rectal bleeding within the first 3 months;
- Individuals with absorption instability caused by cystic fibrosis, untreated megacolon disease, or known DNA abnormalities (such as familial adenomatous polyposis, Fanconi syndrome);
- Serious active, uncontrolled, untreated, acute onset systemic diseases (such as cardiovascular, respiratory, renal, infectious, endocrine, liver or central nervous system, etc.);
- Pregnant or breastfeeding women.
- The investigator believes the subject is unsuitable for participating in this clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.