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

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.

Study Overview

• Status: Completed
• Conditions: Fructan Intolerance
• Intervention / Treatment: Drug: Placebo; Drug: Sacrosidase Oral Solution

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Boston Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ability to comprehend and provide a signed and dated informed consent form
• Stated willingness to comply with all study procedures and attend all scheduled clinic visits, and continue participation for the duration of the study
• Ability to self-administer oral medication and willingness to adhere to the medication regimen
• Male or non-pregnant, non-lactating female, at least 18 years of age
• Sexually active women of childbearing potential must agree to use at least one reliable method of birth control while participating in the study
• Presence of fructan intolerance as determined by a positive result on a FBT within the last 6 months
• Subjects who are lactose intolerant agree to eliminate all lactose from their diet during the study
• Stated willingness to discontinue any medications to resolve GI symptoms (digestive enzymes, antacids, proton pump inhibitors, histamine-2 blockers, promotility agents, or anti-diarrheal agents, etc.), per the investigator's discretion.
• Stated willingness to discontinue any over the counter or prescribed oral nonsteroidal anti-inflammatory drugs (NSAIDs) during the study
• Per the discretion of the investigator, absence of any GI disorder other than a diagnosis of fructan intolerance

Exclusion Criteria:

• History of inflammatory bowel disease or active low-grade GI bacterial infection, as diagnosed by the presence of fecal calprotectin
• History of celiac disease, as diagnosed by serology testing for anti-gluten protein antibodies
• History of CSID, as diagnosed by the sucrose hydrogen-methane breath test,
• Abnormal uncontrolled thyroid function, detected by abnormal TSH level in the blood
• Per the discretion of the investigator, history of a serious physical or mental disorder
• BMI greater than 30 kg/m2
• History of diabetes
• History of hypersensitivity to yeast, yeast products, glycerin (glycerol), or papain

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Subjects will be randomized to take active treatment, sacrosidase, 2 mL (17,000 IU) with every meal or snack, administered orally following dilution with 2 to 4 ounces (60 to 120 mL) of water or milk (either cold or at room temperature) during either Treatment Period 1 or Treatment Period 2. The study treatment period is one week.	Drug: Sacrosidase Oral Solution; Study drug; Other Names: sacrosidase
Placebo Comparator: Placebo; Subjects will be randomized to take placebo treatment, sacrosidase placebo, 2 mL (17,000 IU) with every meal or snack, administered orally following dilution with 2 to 4 ounces (60 to 120 mL) of water or milk (either cold or at room temperature) during either Treatment Period 1 or Treatment Period 2. The study treatment period is one week.	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mean (SD) Total Symptom Score (TSS) at 1 Week	The numeric value of the Total Symptom Score (TSS) is derived from the Daily Symptom Questionnaire (DSQ). The DSQ consisted of rating the frequency in the last 24 hours and the severity of 7 symptoms, abdominal bloating, abdominal pain, abdominal cramps, abdominal gas/flatulence, constipation, nausea, and diarrhea. The daily symptom score is calculated by summing the frequency and severity scores for each symptom with a minimum daily score of 0 and a maximum daily score of 98. The TSS is calculated by averaging the combined daily symptom scores during a 7-day period for baseline and 1-week post-intervention during each treatment period and ranges from 0-98, with higher values representing a worse outcome.	Baseline and 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mean (SD) Frequency Score for Abdominal Bloating From Baseline to 1 Week	The Daily Symptom Questionnaire (DSQ) consisted of rating the frequency in the last 24 hours and the severity of 7 symptoms, abdominal bloating, abdominal pain, abdominal cramps, abdominal gas/flatulence, constipation, nausea, and diarrhea. The frequency score for abdominal bloating experienced is calculated by averaging the combined daily scores during a 7-day period for baseline and 1-week post-intervention during each treatment period and ranges from 0-5, with higher values representing a worse outcome.	Baseline and 1 week

Collaborators and Investigators

• Sponsor: QOL Medical, LLC
• Investigators: Principal Investigator: Weng Tao, M.D., Ph. D, QOL Medical, LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2023
• Primary Completion (Actual): January 22, 2024
• Study Completion (Actual): January 22, 2024

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; beta-Fructofuranosidase
• Other Study ID Numbers: SSDXA-14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No