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NCT05703009 | Completed | Fructan Intolerance

Effects of Sacrosidase and Placebo in Subjects With Fructan Intolerance
Sponsor:

QOL Medical, LLC

Brief 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.

Condition or disease

Fructan Intolerance

Intervention/treatment

Sacrosidase Oral Solution

Placebo

Phase

Phase 2

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
Estimated Enrollment : 25 participants
Masking : Quadruple
Primary Purpose : Treatment
Official Title : A Double-Blind, Placebo-Controlled, Crossover Study of Sacrosidase for the Treatment of Subjects With Fructan Intolerance
Actual Study Start Date : June 5, 2023
Estimated Primary Completion Date : January 22, 2024
Estimated Study Completion Date : January 22, 2024
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

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
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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 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
Effects of Sacrosidase and Placebo in Subjects With Fructan Intolerance

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Effects of Sacrosidase and Placebo in Subjects With Fructan Intolerance

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Locations

Not yet recruiting

United States, Massachusetts

Boston Specialists

Boston, Massachusetts, United States, 02111