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Healthy stool study aims to sharpen IBD diagnosis

NCT ID NCT07089420

Knowledge-focused Sponsor: American Laboratory Products Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study measured calprotectin, a protein in stool that signals gut inflammation, in 121 healthy adults aged 22 and older. Participants collected a single stool sample at home and mailed it in. The goal is to establish what level is normal, helping doctors better tell apart inflammatory bowel disease (like Crohn's or colitis) from non-inflammatory conditions like irritable bowel syndrome.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study will give doctors a clearer normal range for calprotectin, making it easier to distinguish inflammatory bowel disease from non-inflammatory conditions.
What could go wrong
This is a small, completed study in healthy volunteers only. It does not test a treatment, so it won't directly change patient care until larger studies confirm the findings.

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.

Participants

121 people

The number who actually took part.

Started

Jul 2025

Finished

Apr 2026

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.

Who is studied

The study will enroll approximately 120 to 150 healthy adult volunteers, aged 22 years or older, from the general U.S. population. Participants must be asymptomatic with no history of inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), gastrointestinal cancer, or other chronic intestinal conditions. Subjects must not be on immunosuppressive therapy, PPIs, H2 blockers, or regular NSAID use prior to sample collection. The goal is to represent a normal, healthy population to establish baseline calprotectin levels using the ALPCO Calprotectin CLIA assay.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Adults aged ≥22 years No abdominal symptoms and no history of inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), or other chronic intestinal disorders May have undergone colonoscopy with negative findings within the past month or never undergone colonoscopy Able and willing to provide a stool sample according to the collection protocol Able to understand the study and sign the informed consent form (ICF) Exclusion Criteria: * Unable or unwilling to provide a stool sample Known active intestinal cancer or history of intestinal cancer with abnormal clinical findings Currently receiving chemotherapy or systemic immunosuppressive medications Use of proton pump inhibitors (PPIs) or H2-receptor antagonists within the last 2 weeks Use of NSAIDs (including aspirin) for 7 or more days in the past 2 weeks Presence of gastrointestinal symptoms such as abdominal pain, diarrhea, altered appetite, weight loss, or anemia Samples collected not following protocol requirements Any other condition that, in the opinion of the investigator, may interfere with study participation or data validity

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease irritable bowel syndrome ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease (CD) IBD (inflammatory bowel disease) IBS - irritable bowel syndrome Uc - ulcerative colitis

Contacts and locations

Locations

  • ALPCO

    Salem, New Hampshire, 03079, United States

More trials for these conditions

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