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Enzyme Replacement Therapy

Sucrase for Short Bowel Syndrome

Phase 2
Recruiting
Led By Amanda Fifi, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Short bowel syndrome, of all ages, with dependence on parental support to provide at least 50% of fluid or caloric needs.
Adult and Pediatric patients (all ages)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to 9 weeks
Awards & highlights

Study Summary

This trial is testing whether exogenous sucrase can improve sucrose digestion in short gut syndrome with intestinal failure patients.

Who is the study for?
This trial is for people of all ages with Short Bowel Syndrome and Intestinal Failure who rely on parenteral support for at least half their nutrition. Participants must consume a diet that includes sucrose and be able to give informed consent. Those currently on IV antibiotics or without enteral nutrition, or with conditions that may risk their safety or study integrity, cannot join.Check my eligibility
What is being tested?
The trial is testing the effectiveness of giving sucrase (an enzyme) to patients who can't digest sugar properly due to Short Bowel Syndrome with Intestinal Failure. It aims to see if taking sucrase helps them tolerate more food orally or through a g-tube compared to a placebo.See study design
What are the potential side effects?
Potential side effects from taking exogenous sucrase could include digestive issues like abdominal pain, bloating, vomiting, and diarrhea since it affects how sugar is processed in the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have short bowel syndrome and need help for more than half of my nutrition or hydration.
Select...
I am of any age.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 9 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to 9 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Carbohydrate Malabsorption
Change in Carbohydrate Malabsorption as measured by enteral nutrition tolerance
Change in Carbohydrate Malabsorption as measured by growth velocity
+1 more
Secondary outcome measures
Change in digestion
Change in digestion as measured by amount of emesis
Change in digestion as measured by stool consistency

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sucrase intervention followed by placeboExperimental Treatment2 Interventions
Participants in this arm will receive sucrase for 4 weeks followed by wash out of 1 week with no drug administered then 4 weeks of placebo.
Group II: Placebo followed by sucrase interventionExperimental Treatment2 Interventions
Participants in this arm will receive placebo for 4 weeks followed by wash out of 1 week with no drug administered then 4 weeks of sucrase.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
897 Previous Clinical Trials
409,611 Total Patients Enrolled
QOL Medical, LLCIndustry Sponsor
5 Previous Clinical Trials
1,389 Total Patients Enrolled
Amanda Fifi, MDPrincipal InvestigatorUniversity of Miami

Media Library

Sucrase (Enzyme Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04604275 — Phase 2
Short Bowel Syndrome Research Study Groups: Sucrase intervention followed by placebo, Placebo followed by sucrase intervention
Short Bowel Syndrome Clinical Trial 2023: Sucrase Highlights & Side Effects. Trial Name: NCT04604275 — Phase 2
Sucrase (Enzyme Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04604275 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential hazards are associated with the ingestion of Sucrase?

"Our team at Power assigned Sucrase a score of 2, signifying that clinical data exists to support the drug's safety but there is no evidence yet attesting to its efficacy."

Answered by AI

How many subjects have been enrolled in this experiment?

"Affirmative. According to clinicaltrials.gov, this study is currently accepting applicants since its first posting on February 2nd 2022 and last edit on October 27th 2022. There are 10 positions open across two medical facilities."

Answered by AI

Is recruitment of participants still open for this investigation?

"According to the clinicaltrials.gov website, this research is currently in the process of recruiting participants. The experiment was listed on February 2nd 2022 and recent modifications occurred on October 27th 2022."

Answered by AI
~2 spots leftby Sep 2024