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NCT03530852 · ClinicalTrials.gov registry record · NA

A 90 Day, Phase 3,Open Labeled Exploratory Study of RELiZORB

A NA study of Short Bowel Syndrome and Malabsorption, sponsored by Boston Children's Hospital.

Recruiting
Registry status
NA
Development phase
32
Enrollment target
1
Study location

NCT03530852: Recruiting NA study of Short Bowel Syndrome and Malabsorption, sponsored by Boston Children's Hospital.

NCT03530852 is a NA study of Short Bowel Syndrome and Malabsorption that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 32 participants, below the 183-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03530852, a NA study of Short Bowel Syndrome and Malabsorption, is actively recruiting participants, sponsored by Boston Children's Hospital.

RECRUITING
Registry status
NA
Development phase
32 participants
Enrollment target
1
Study location

Study Summary

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

Primary Outcome

To determine the effectiveness of the RELiZORB enzyme cartridge on the absorption of enteral nutrition when used daily for a total 90 days of treatment, in pediatric subjects with SBS who are PN dependent, aged 2 years - 18 years, by measuring the change in PN calories from baseline, assessed at days 7, 14, 28, 60, and day 90. Each subject will be on the study for a total of 90 days.

Interventions

  • DEVICE Relizorb

Study Locations (1)

Massachusetts

  • Boston Children's Hospital - Boston

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2018-11-21
Est. Completion 2028-09-30
Phase NA
Boston Children's Hospital

462 total trials

What NCT03530852 shows while recruiting

NCT03530852 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 183-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (83% lower).

The record links to 2 conditions, with Short Bowel Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Relizorb is the first listed.

NCT03530852 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT03530852 about?

NCT03530852 is a clinical study titled "A 90 Day, Phase 3,Open Labeled Exploratory Study of RELiZORB". 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 fa...

What is the current status of trial NCT03530852?

This trial is currently recruiting. It is a NA study. The enrollment target is 32 participants. The study started on 2018-11-21. Estimated completion is 2028-09-30.

What conditions does trial NCT03530852 study?

This clinical trial studies the following conditions: Short Bowel Syndrome, Malabsorption.

What interventions are being tested in trial NCT03530852?

The interventions under investigation include: Relizorb (DEVICE).

Who is sponsoring clinical trial NCT03530852?

This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03530852 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Short Bowel Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03530852's enrollment target sits among peer trials

32 14th of 17 higher than 4 of 17 other Short Bowel Syndrome trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Short Bowel Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03530852, the US trial registry maintained by the National Library of Medicine. NCT03530852 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.