FT1 for adults with short bowel syndrome: a safe, quick-study test

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this phase 2, randomized, double-blind, placebo-controlled crossover study, adults with short bowel syndrome receive weekly injections of FT1 or placebo for five weeks, followed by a washout and then the alternate treatment for another five weeks. Efficacy is assessed with a 72-hour metabolic balance study at baseline and after each treatment period. The study also examines the pharmacokinetics and pharmacodynamics of FT1 to understand how the drug behaves in the body.

Why it matters

Who can join: the full rules

Inclusion 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;

Exclusion Criteria:

* 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 carcinoma in situ of the breast after radical surgery);
* 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 month or during the screening period;
* 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.

Where it's running

• General Hospital of Eastern Theater Command
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Jing Sun
• Email: sunj@pegbiocq.com
• Phone: +86-13983367811

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Creating a quick quality-of-life questionnaire for people with short bowel syndrome

  This project will try a shorter, easier quality-of-life questionnaire for adults with short bowel syndrome and compare it with the existing SBS QoL tool.

  Recruiting Hospices Civils de Lyon · Pierre-Bénite · NCT06771505

• Evaluating the Eclipse XL1 System for treating Short Bowel Syndrome

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  Recruiting at 5 sites Eclipse Regenesis, Inc. · Palo Alto, California and 4 other locations · NCT05535361

• Assessing a new treatment for Short Bowel Syndrome

  This study is testing a new treatment for adults with Short Bowel Syndrome to see if it can help improve their condition compared to a placebo.

  Recruiting at 15 sites Phase 2 Hanmi Pharmaceutical Company Limited · Boston, Massachusetts and 14 other locations · NCT04775706

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.