Effects of Sacrosidase and Placebo in Subjects With Fructan Intolerance

• Status: Not yet recruiting
• Trial end date: 2023-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: QOL Medical, LLC

Criteria

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 2 years

• 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