Your session is about to expire
← Back to Search
Sucraid for Congenital Sucrase-Isomaltase Deficiency
Study Summary
This trial will study the response of 1100 children with CSID to a 7-day treatment of Sucraid. It will also look at the relationship between known CSID mutations and sucrase activity levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I have a history of diabetes.I have a disease that is not currently under control.I have not had a fever or flu-like symptoms in the last 5 days.Participants will be grouped based on their sucrase levels into three groups: low sucrase (<25), medium sucrase (25-35), and high sucrase (>55).I have symptoms like diarrhea or abdominal pain at least 3 times a week for the last 3 months.I am between 6 months and 17 years old.I can follow the study's requirements, use a mobile device for questionnaires, and attend all visits.I understand and can follow the study's requirements.You had a test to measure certain enzymes in your digestive system within the past year, and the results were normal.My abdominal issues are not due to conditions like IBD, celiac, or pancreatitis.You are allergic to sucrose, yeast, papain, or glycerol.I have previously taken Sucraid®.I am not pregnant or breastfeeding.
- Group 1: Single Arm Open Labeled Commercial Sucraid
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Might I be eligible to participate in this experiment?
"This clinical trial is recruiting 1100 minors, aged 6 months to 17 years old, who are diagnosed with abetalipoproteinemia. Additionally, the patient must have had a disaccharidase assay (DA) performed within the past year displaying normal histological findings and sucrase levels that fall into one of three ranges: < 25; 25-35; > 55. Other criteria include having at least one symptom related to CSID 3 or more times per week for 3+ months, being a resident in the United States, providing informed consent/assent before any study procedures take place, and understanding English language instructions."
Has the FDA validated Sucraid (sacrosidase) Oral Solution 8500 IU/mL?
"Our team at Power has evaluated the safety of Sucraid (sacrosidase) Oral Solution 8500 IU/mL and, given that it is a Phase 4 trial with an approved treatment, they have assigned a risk score of 3."
What is the size of the participant pool for this experimentation?
"Affirmative. The details shared on clinicaltrials.gov demonstrate that this research project, first published on August 1st 2022, is still open for participants. Approximately 1100 individuals need to be recruited from 7 different medical facilities."
Are geriatric individuals eligible for this clinical trial?
"Those who are between 6 months and 17 years of age may take part in this investigation."
What is the geographic scope of this trial's implementation?
"This clinical trial is hosted by McGovern Medical School of UT Health in Houston, Texas, GI For Kids, PLLC in Knoxville, Tennessee and Center for Digestive Health Care, LLC in Atlanta Georgia. It also has 7 other participating research facilities."
Is the enrollment period still open for this research project?
"Indeed, clinicaltrials.gov's records demonstrate that this trial is actively searching for participants and was most recently updated on October 26th 2022 after its initial dissemination on August 1st of the same year."
Popular Categories
Share this study with friends
Copy Link
Messenger