Boston, MANCT03530852Now EnrollingIRB Ready

Short Bowel Syndrome Clinical Trial in Boston, MA

Access cutting-edge short bowel syndrome treatment through this clinical trial at a research site in Boston. Study-provided care at no cost to qualified participants.

Sponsored by Boston Children's Hospital

Quick Self-Assessment

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Expert Care in Boston

Access short bowel syndrome specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related short bowel syndrome treatment provided free

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Check if you qualify for this short bowel syndrome clinical trial in Boston, MA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Boston

    Convenient for MA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Boston site if eligible
  4. 4Begin participation

About This Short Bowel Syndrome Study in Boston

Children with inadequate intestinal absorption due to loss of large amounts of small bowel require intravenous nutrition (feeding through the vein) to sustain hydration and nutrition to avoid starvation and dehydration; however, intravenous (IV) nutrition can lead to complications including liver failure. Tube feeding directly to the small intestine avoids the complications of IV nutrition, but fats are not fully digestible due to inadequate bowel function. We propose to predigest the fat using a small cartridge attached to the feeding tube to allow for rapid absorption with the possibility of reducing or eliminating the need for intravenous nutrition

Sponsor: Boston Children's Hospital

Who Can Participate

Inclusion Criteria

Male or female patients, ages 2 years to 18 years, inclusive.
Diagnosed with SBS, as determined by medical history and PN dependence (i.e. need for PN for \>60 days after intestinal resection or a bowel length \<25% of expected).
Congenital or acquired gastrointestinal disease requiring surgical intervention that has occurred at least 3 months prior to screening.
Patient is on parenteral lipid and at least 30% of daily caloric and fluid intake has been provided by PN for a least 6 months prior to screening
Stable PN nutrition requirement, determined by less than 5% reduction in PN nutrition calories for at least 1 month prior to screening, or at the discretion of the investigator.
The patient has a Central Venous Catheter (CVC) at the time of study inclusion.
Screening direct bilirubin that is in the normal range for age and is not determined to be clinically significant by the investigator.
The patient has an existing feeding tube, receiving enteral nutrition via an enteral feeding pump at a rate\>10ml/hr but \<400 ml/hr, and is able to tolerate at least 10 ml/kg/day enteral nutrition with which the RELiZORB cartridge can be used. The patient can be on bolus or continuous feeds and can use up to 6 cartridges per day for feeding.
Stable enteral nutrition requirement with no change in formula composition or rate for at least 1 month prior to screening.
The parent or legal guardian of the patient is able to read, understand, and is willing to provide informed consent (and assent, if applicable).
The patient (if assent is applicable) or parent or legal guardian of the patient is able to understand the requirements of the study and is willing to bring the patient to all clinic visits and complete all study related procedures (as determined by the investigator).
A parent or legal guardian is willing to provide written authorization for the use and disclosure of protected health information.

Exclusion Criteria

Other causes of chronic liver disease other than SBS (i.e., hepatitis C, cystic fibrosis, biliary atresia, alpha 1 anti-trypsin deficiency, and Alagille syndrome).
The patient has had a bowel lengthening procedure, including but not limited to, a STEP procedure.
Any serum triglyceride concentration \>400 mg/dL at screening.
Pancreatic insufficiency as defined as the use of pancreatic enzymes within 30 days prior to screening.
Evidence of untreated intestinal obstruction or active stenosis, as determined by the investigator.
Unstable absorption due to cystic fibrosis or known DNA abnormalities (i.e., familial adenomatous polyposis, Fanconi syndrome) as determined by the investigator.
History of microvillus inclusion disease, as determined by medical history.
Severe known dysmotility syndrome (i.e., pseudo-obstruction, gastroschisis-related motility disorders), as determined by the investigator.
Initiation of teduglutide or other GLP-2 analogues within 6 months of screening
Use of growth hormone, or supplemental glutamine within 3 months prior to screening.
Use of cisapride within 30 days prior to screening.
Active clinically significant pancreatic or biliary disease, as determined by the investigator.
Patients are receiving formulas that are not compatible with the RELiZORB cartridge (example, insoluble fiber-containing formulas)
Determined by the investigator to be unsuitable for participation for any reason.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT03530852) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Short Bowel Syndrome Treatment Options in Boston, MA

If you're searching for short bowel syndrome treatment options in Boston, MA, this clinical trial (NCT03530852) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced short bowel syndrome specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all short bowel syndrome clinical trials near you to find additional studies recruiting in your area.

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