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Fungal enzymes could replace pig enzymes for digestive aid in pancreatitis

NCT ID NCT07697352

Disease control Sponsor: Asian Institute of Gastroenterology, India Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
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Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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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 Results may not be published yet.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)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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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

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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This status has not been confirmed recently, so it may be out of date.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 Jul 13, 2026 · Last updated Aug 27, 2026 · Updated 4 times

Summary

This trial compares fungal-based pancreatic enzymes to standard pig-derived enzymes in people with chronic pancreatitis and digestive insufficiency. Participants take either the fungal or porcine enzyme for 12 weeks to see if the fungal version works just as well. The goal is to provide a non-porcine option that respects religious and dietary preferences.

What this could mean

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

Active substance
Fungal-based pancreatic enzymes (amylase, lipase, protease)
What this could lead to
If successful, this could offer a culturally acceptable, non-porcine alternative for managing pancreatic enzyme insufficiency, avoiding religious or dietary conflicts.
What could go wrong
This is a single-center trial with 134 participants, so results may not apply broadly. The fungal enzymes might not match the effectiveness of the standard porcine treatment.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 134 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

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 to 60 years

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: * CP fulfilling the M-ANNHEIM criteria 11 with documented PEI (defined as fecal elastase \<100 µg/g stool on the background of morphological changes of CP). * Pancreatic exocrine insufficiency questionnaire score (PEI-Q) \>1.4 * Willingness to undergo a 2-week wash-out period without pancreatic enzyme therapy before enrolment. * Willing and able to provide written informed consent. Exclusion Criteria: * Major psychiatric illness impairing study participation. * Systemic illness affecting digestion or study outcomes. * Any condition deemed unsuitable for study participation by the investigator. * Concurrent acute exacerbation of the CP at the time of screening.

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Conditions

The condition(s) this trial relates to.

chronic pancreatitis exocrine pancreatic insufficiency

As listed by the trial registrant

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

Exocrine pancreatic insufficiency (EPI) Pancreatitis, chronic

How to take part

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  1. The official record

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  2. A doctor treating you

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