Fructan Intolerance
Conditions
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.
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.
Interventions
DRUGSacrosidase Oral Solution
Study drug
DRUGPlacebo
Placebo
Sponsors
QOL Medical, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean (SD) Total Symptom Score (TSS) at 1 Week | Baseline and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean (SD) Frequency Score for Abdominal Bloating From Baseline to 1 Week | Baseline and 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWeng Tao, M.D., Ph. D
QOL Medical, LLC
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Age, Continuous | 36.3 years STANDARD_DEVIATION 10.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 3 / 25 | 3 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
None listed