NCT05703009

Effects of Sacrosidase and Placebo in Subjects With Fructan Intolerance

A Double-Blind, Placebo-Controlled, Crossover Study of Sacrosidase for the Treatment of Subjects With Fructan Intolerance

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: QOL Medical, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

SSDXA-14 is a Phase 2 (feasibility/pilot) double-blind, placebo-controlled, crossover study to evaluate the efficacy and safety of sacrosidase and placebo in 25 subjects objectively diagnosed with fructan intolerance.

Detailed description

This Phase 2 study will evaluate the efficacy and safety of sacrosidase and placebo in male and female subjects aged 18 years or older objectively diagnosed with fructan intolerance via fructan breath test within 6 months prior to informed consent and are negative for inflammatory bowel disease or low-grade GI bacterial infection, detected by fecal calprotectin test, celiac disease, detected by serology for anti-gluten protein antibodies, congenital sucrase-isomaltase deficiency (CSID), detected by sucrose hydrogen-methane breath test, and have a negative result for abnormal uncontrolled thyroid function, detected by the standard TSH blood test. This study will consist of a Screening Visit, Baseline Period, Treatment Period 1, Washout Period, and Treatment Period 2. Subjects will be required to attend 5 clinic visits during study participation. Subjects will be randomized in a 1:1 fashion to either receive sacrosidase or placebo during Treatment Period 1. Following a 7-day Washout Period, subjects will receive their crossover study medication for Treatment Period 2. Subjects will take their assigned study medication for 7 days during each Treatment Period.

Conditions

• Fructan Intolerance

Interventions

Type	Name	Description
DRUG	Sacrosidase Oral Solution	Study drug
DRUG	Placebo	Placebo

Timeline

• Start date: 2023-06-05
• Primary completion: 2024-01-22
• Completion: 2024-01-22
• First posted: 2023-01-27
• Last updated: 2024-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study