An observational study in Short Bowel Syndrome and Malabsorption, sponsored by Boston Children's Hospital. Enrolling by invitation at 2 sites in United States. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Boston Children's Hospital · Observational
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. Goal of the observational study is to determine safety and tolerability of Relizorb Enzyme Cartridge for an additional 90 days after the original trial
Short bowel syndrome (SBS) is often due to the loss of large amounts of small intestine that compromises digestive absorption. The treatments include (1) a high-calorie diet that includes vitamins, minerals, carbohydrates, proteins and fats; (2) injections of vitamins and minerals; (3) administration of drugs to slow the normal movement of the intestine or to increase the surface area of the intestinal lining; and (4) feeding through the vein (i.e., parenteral nutrition or PN). Many patients cannot wean from PN due to reduced intestinal length or function. Patients on long-term PN frequently experience serious metabolic complications, sepsis, hepatic biliary disorders including cholestasis, and fibrosis and can progress to liver failure. Full intestinal feeding (enteral nutrition) without PN is the optimal way to prevent the above complications.
Enterally administered long chain triglycerides in patients with SBS, especially those with hepatic dysfunction, are not well tolerated due to bile acid malabsorption, which leads to decreased micelle formation and fat digestion. The dietary fat is unable to be emulsified by the bile acids and acted on by lipases before exiting the patient as stool. Switching to other forms of fat such as medium-chain triglycerides (MCTs) that do not require micelles for absorption may be better tolerated in patients with bile acid or pancreatic insufficiency but are not optimal as they increase the osmotic load in the intestine. This may increase the chance of stool dumping; moreover, MCTs do not contain essential fatty acids (FAs). The ability to provide the essential FAs such as those present in enteral formulas in a form that does not require the formation of micelles for absorption, would allow patients with SBS and those who are no longer PN dependent to receive adequate nutrition and continue to maintain the same growth trajectory as when they received the majority of their nutrition parenterally.
RELiZORB is a digestive enzyme cartridge connected in-line with enteral feed tubing sets designed to mimic the function of pancreatic lipase. It is hypothesized that by using an external lipase device (RELiZORB) enteral nutrition will be better absorbed, and PN dependence reduced as enteral autonomy is increased. This product uniquely eliminates the need for intestinal emulsification and lipase activity and eliminates the risk of drugs, including lipases, allowing absorption at the time the diet enters the gut. The device has been shown to digest >90% of fat in most enteral formulas.
Goal of the observational study is to determine safety and tolerability of Relizorb Enzyme Cartridge for an additional 90 days after the original trial. Patients with short bowel syndrome aged 2-18 who are dependent on parenteral nutrition and enteral feeds who completed the original Relizorb Trial. Participants will continue to use the Relizorb device with enteral nutrition for 90 additional days.
Primary objective:
•To evaluate the effect of the RELiZORB enzyme cartridge when used with enteral nutrition daily for an additional 90 days (for a total of 180 days from enrollment) on the change from baseline in PN calories.
Secondary objective:
•To evaluate the effect of the RELiZORB enzyme cartridge when used with enteral nutrition daily for an additional 90 days (for a total of 180 days from enrollment) on the change from baseline in body weight
159 studies on the registry are indexed under Short Bowel Syndrome; 24 are open to participants now.
This study's planned enrollment of 32 is below the median of 53 across 36 observational studies indexed under Short Bowel Syndrome.
Browse Short Bowel Syndrome studies →Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
A total of 32 pediatric subjects with SBS, aged 2 years - 18 years who are PN dependent are expected to be enrolled in the ongoing clinical study and will be invited to participate in this extension study. Eligibility will be established by the investigator based on the inclusion and exclusion criteria for the extension study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients aged 2-18 who have completed the 90 day open label phase 3 Relizorb trial who consent to the 90 day observational Relizorb extension trial
Device: Relizorb Enzyme Cartridge
Tube feeds run across device to digest fats.
To evaluate the effect of the RELiZORB enzyme cartridge when used with enteral nutrition daily for an additional 90 days
change from baseline in PN calories
Time frame: 90 days
To evaluate the effect of the RELiZORB enzyme cartridge when used with enteral nutrition daily for an additional 90 days
the change from baseline in body weight (weight-for-age z-score).
Time frame: 90 days
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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