Effects of Sacrosidase and Placebo in 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.

Inclusion Criteria:Ability to comprehend and provide a signed and dated informed consent formStated willingness to comply with all study procedures and attend all scheduled clinic visits, and continue participation for the duration of the studyAbility to self-administer oral medication and willingness to adhere to the medication regimenMale or non-pregnant, non-lactating female, at least 18 years of ageSexually active women of childbearing potential must agree to use at least one reliable method of birth control while participating in the studyPresence of fructan intolerance as determined by a positive result on a FBT within the last 2 yearsSubjects who are lactose intolerant agree to eliminate all lactose from their diet during the studyStated 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 studyPer the discretion of the investigator, absence of any GI disorder other than a diagnosis of fructan intoleranceExclusion Criteria:History of inflammatory bowel disease or active low-grade GI bacterial infection, as diagnosed by the presence of fecal calprotectinHistory of celiac disease, as diagnosed by serology testing for anti-gluten protein antibodiesHistory of CSID, as diagnosed by the sucrose hydrogen-methane breath test,Abnormal uncontrolled thyroid function, detected by abnormal TSH level in the bloodPer the discretion of the investigator, history of a serious physical or mental disorderBMI greater than 30 kg/m2History of diabetesHistory of hypersensitivity to yeast, yeast products, glycerin (glycerol), or papain