Chyme reinfusion using The Insides® System to reduce parenteral nutrition dependence in Type 2 intestinal failure
A multicentre study evaluating whether device-assisted chyme reinfusion can reduce parenteral nutrition requirements in adults with Type 2 intestinal failure.
REINFUSE was conducted across 12 participating centres in the United Kingdom and United States, with 39 participants randomised between October 2022 and August 2025.
12 Participating centers
39 participants randomised
UNITED KINGDOM + UNITED STATES
Participant enrolment: October 2022 – August 2025
What was the study designed to assess?
REINFUSE assessed whether device-assisted chyme reinfusion could reduce parenteral nutrition requirements in adults with Type 2 intestinal failure caused by DES or ECF.
PRIMARY ENDPOINT
STUDY ASSESSMENT TIMELINE
Baseline
Day 30
Primary Endpoint
≥50% reduction
in PN calories
Day 60
SECONDARY ENDPOINTS
PN cessation
Intestinal losses
Nutritional Risk Index
Quality of life
Satisfaction
Safety
How was the study conducted?
39
Participants
Adults with Type 2 intestinal failure
from DES or ECF
Randomised 2 : 1
Control
n = 13
Standard care
PN only
Active
n = 26
Standard care + CRT
using The Insides® System
Outcomes assessed through Day 60
What did REINFUSE find?
43%
Completely Ceased PN by Day 60
vs 0% control
70%
Reduction in intestinal losses
-1450 mL/day
46/50
Patient satisifaction score by Day 60
Parenteral nutrition dependence over time
DAY 30 PRIMARY ENDPOINT
31%
Active group achieved ≥ 50% PN calorie reduction
0%
Control group achieved ≥50% PN calorie reduction
The result did not meet the prespecified adjusted statistical significance threshold.
.png)
.png){kind=small}
.png){kind=small}
