Could an enzyme help people digest fructans?

NCT ID NCT05703009

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

25 people

The number who actually took part.

Started

Jun 2023

Finished

Jan 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Boston Specialists

    Boston, Massachusetts, 02111, United States