Clinical Trial: A 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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Frequency of Genetic Sucrase-Isomaltase Deficiency Genotypes, and the Efficacy and Safety of Sucraid® (Sacrosidase) Oral Solu

Brief Summary: S09A is a Phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel study examining the efficacy and safety of a Sucraid (sacrosidase) Oral Solution in comparison to a placebo in 150-200 subjects with chronic diarrhea possibly attributable to sucrase deficiency.

Detailed Summary:
Sponsor: QOL Medical, LLC

Current Primary Outcome: Response to Sucraid and placebo in a parallel group study based on improvement in daily stool consistency, as assessed by the BSFS using SHMBT [ Time Frame: Up to 2 years ]

Response to Sucraid and placebo based on improvement in daily stool consistency, as assessed by the Bristol Stool Form Scale (BSFS) over a 1-week treatment period in subjects with chronic diarrhea and sucrase deficiency using a sucrose hydrogen methane breath test (SHMBT).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Effects of Sucraid and placebo on daily assessments of Bristol Stool Form Scale [ Time Frame: Up to 2 years ]
  • Effects of Sucraid and placebo on daily stool frequency [ Time Frame: Up to 2 years ]
  • Effects of Sucraid and placebo on daily abdominal pain [ Time Frame: Up to 2 years ]
  • Effects of Sucraid and placebo on daily bloating severity [ Time Frame: Up to 2 years ]
  • The relationship between the severity of sucrase deficiency, quantified by a SHMBT [ Time Frame: Up to 2 years ]
  • The mean improvement in the BSFS for each treatment group. [ Time Frame: Up to 2 years ]
  • Overall frequency of the 4 most common sucrase-isomaltase deficiency genetic variants [ Time Frame: Up to 2 years ]
    Overall frequency of the 4 most common sucrase-isomaltase deficiency genetic variants in comparison to the frequency in public proxy databases of broad populations.
  • The number of less common sucrase-isomaltase polymorphisms in this study population. [ Time Frame: Up to 2 years ]
  • The allele frequency of the most common sucrase-isomaltase genetic variants in subjects with chronic diarrhea attributable to sucrase deficiency compared to the allele frequency in other databases [ Time Frame: Up to 2 years ]
    Assess the allele frequency of the 38 most common sucrase-isomaltase genetic variants in subjects with chronic diarrhea attributable to sucrase deficiency compared to the allele frequency of sucrase-isomaltase genetic variants in the Exome Variant Server, the ExAC server, and other public proxy and private genetic databases.


Original Secondary Outcome: Same as current

Information By: QOL Medical, LLC

Dates:
Date Received: May 18, 2016
Date Started: May 2016
Date Completion: December 2017
Last Updated: June 2, 2016
Last Verified: June 2016