Effects of Sacrosidase and Placebo in Subjects With Fructan Intolerance

NCT05703009 | Completed Phase 2 FDA Drug

• 1 other identifier: SSDXA-14
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Fructan Intolerance

Outcome Measures

Primary Outcomes (1)

• Change in incidence and severity of gastrointestinal symptoms in subjects with fructan intolerance treated with sacrosidase and placebo

  Change from baseline as determined by the Daily Symptom Questionnaire Total Symptom Score (TSS) rating severity on a scale from 0 to 9 and frequency on a scale from 0 to 5, based on a mean value of combination scores for, incidence of seven GI symptoms experienced in the past 24 hours during a 7-day period and severity of seven GI symptoms experienced in the past 24 hours during a 7-day period.

  Up to 7 weeks

Secondary Outcomes (2)

• Change in incidence and severity of abdominal pain in subjects with fructan intolerance treated with sacrosidase and placebo

  Up to 7 weeks

• Assess the safety and tolerability of sacrosidase compared to placebo in subjects with fructan intolerance

  Up to 1 year

Study Arms (2)

Treatment

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Interventions

Sacrosidase Oral Solution DRUG

Study drug

Also known as: sacrosidase

Treatment

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• QOL Medical, LLC: lead

Study Sites (1)

Boston Specialists

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Interventions

beta-Fructofuranosidase

Intervention Hierarchy (Ancestors)

Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Officials

• Weng Tao, M.D., Ph. D

  QOL Medical, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: June 5, 2023
• Primary Completion: January 22, 2024
• Study Completion: January 22, 2024
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

US (1)