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New blood test could spot hidden digestive problems in pancreatitis patients

NCT ID NCT07418593

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 2 times

Summary

This study tests a new blood test (Malabsorption Blood Test, or MBT) to find mild-to-moderate pancreatic insufficiency in people with chronic or recurrent acute pancreatitis. A small group of participants who respond to pancreatic enzyme replacement therapy (PERT) will then be randomly assigned to receive either PERT or a placebo for 8 weeks to see if their quality of life improves. The goal is to see if the blood test can guide treatment decisions.

What this could mean

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

Active substance
Pancreatic Enzyme Replacement Therapy (PERT)
What this could lead to
If successful, this blood test could help doctors identify which patients with chronic pancreatitis would benefit from enzyme replacement therapy, potentially improving their quality of life.
What could go wrong
This is a small, early-phase pilot study with only 80 participants. The blood test may not accurately identify all patients who need treatment, and the quality-of-life improvements seen may not hold up in larger trials.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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 * ≥ 18 years of age * RAP (≥ 2 documented lifetime attacks with ≥ 2 of 3 acute pancreatitis criteria) OR Chronic pancreatitis (Cambridge I or II with documented history of AP OR Cambridge III or IV criteria) * Fecal elastase ≥ 50 within the preceding 12 months Exclusion Criteria * Allergy/Intolerance to PERT/MBT * Taking medications that alter fat absorption or that supplement the fatty acids being studied (e.g. orlistat, ursodeoxycholic acid, Fatty-15 fatty acid supplement etc.) * Taking GLP-1 Receptor Agonist therapy * Fecal elastase \<50 within preceding 12 months OR pre-existing diagnosis of severe Exocrine Pancreatic Insufficiency, or ongoing steatorrhea * Receiving Pancreatic Enzyme Replacement Therapy for \> 5 days within the preceding 30 days * Acute Pancreatitis attack (documented and meeting at least 2 of 3 criteria) within the preceding 90 days * History of pancreatic resection or underlying malabsorptive disease * Pregnant or Breast Feeding * Other significant medical condition as judged by Principal Investigator

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Johns Hopkins Medicine

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21287, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

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