Evaluation of the Efficacy and Safety of Sucraid (Sacrosidase) Oral Solution in Adults

Condition

  • Sucrase deficiency


Study Name

A Multi-Center, Double-Blind, Placebo-Controlled Trial to Evaluate the Frequency of Genetic Sucrase-Isomaltase Deficiency Genotypes, and the Efficacy and Safety of Sucraid (Sacrosidase) Oral Solution in Subjects With Chronic Diarrhea and Sucrase Deficiency (IRB no. 43663)


Phase

Phase IV


Summary

The purpose of this study is to evaluate the investigational use of a drug called Sucraid (sacrosidase) in patients who have chronic, or long-term, diarrhea due to a lack of sucrase. Sucrase is a product made in the digestive system (enzyme). Enzymes work to break down food and help the intestines absorb nutrients; enzyme deficiency can cause long-term diarrhea. Researchers aim to determine whether the study drug, Sucraid, works better than no treatment at all in improving the consistency of stool. Participants will be randomly assigned to receive either Sucraid or placebo (inactive substance).

Financial disclosure: Mark Pimentel, MD, and Ali Rezaie, MD, receive payment from Commonwealth Laboratories, LLC, which is the company supplying the Sucrose Hydrogen Metabolic Breath Test (SHMBT) and analyzing the results. Dr. Pimentel receives research grants from Commonwealth. Mark Pimentel, MD, and Ali Rezaie, MD, both serve as consultants for the company.


Eligibility

Key Inclusion Criteria

  • At least 16 years old
  • Women of childbearing potential must be willing to use contraception.
  • Minimum of three months of self-reported diarrhea
  • Able to read, speak and understand English

Key Exclusion Criteria

  • Recent history of functional or chronic constipation
  • History of ulcerative colitis, Crohn’s disease or celiac disease
  • Hypersensitivity to papain, glycerol or yeast

Please see additional list of inclusion and exclusion criteria.


Principal Investigator

Mark Pimentel, MD


Contact

Tahli Singer-Englar
Phone: 310-423-3792
Email: tahli.singerenglar@cshs.org

Kathleen Shari Chua
Email: kathleenshari.chua@cshs.org