Could an enzyme help people digest fructans?
NCT ID NCT05703009
First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times
Summary
This Phase 2 study tested whether an oral enzyme called sacrosidase can reduce digestive symptoms in people with fructan intolerance. Twenty-five adults with confirmed fructan intolerance took either the enzyme or a placebo for one week, then switched after a washout period. The study measured changes in symptoms like bloating, pain, and gas.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sacrosidase (oral solution)
- What this could lead to
- If it works, this could point toward a treatment to ease digestive symptoms for people with fructan intolerance.
- What could go wrong
- This is a small, early Phase 2 pilot study with only 25 participants. Results may not be conclusive or apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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25 people
The number who actually took part.
- Started
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Jun 2023
- Finished
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Jan 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Boston Specialists
Boston, Massachusetts, 02111, United States