Effects of Sacrosidase and Placebo in Subjects With Fructan Intolerance

Completed · Phase 2 · Has a placebo group

Conditions studied: Fructan Intolerance

In brief

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.

Key facts

Study ID

NCT05703009

Run by

QOL Medical, LLC

People needed

25

Starts

2023-06-05

Expected to finish

2024-01-22

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Boston Specialists — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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