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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Response to Sucraid and placebo in a parallel group study based on improvement in daily stool consistency, as assessed by the BSFS using SHMBT
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).
Time frame: Up to 2 years
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
Overall frequency of the 4 most common sucrase-isomaltase deficiency genetic variants in comparison to the frequency in public proxy databases of broad populations.
Time frame: Up to 2 years
The number of less common sucrase-isomaltase polymorphisms in this study population.
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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
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.
Time frame: Up to 2 years