NCT06147635

Brief Summary

The goal of this clinical trial is to investigate the possible effects of tributyrin supplementation in patients with a first episode of acute pancreatitis. The main question it aims to answer is: • The effect of oral tributyrin supplementation on the plasma endotoxin level Participants will be randomized between two groups: intervention and control group. They will receive: \- three times daily 4grams of micro-encapsulated granules of tributyrin, and the control group three times daily 4 grams of micro-encapsulated sunflower oil (i.e. placebo), for a total of 14 days In total 92 adult patients with a first episode of acute pancreatitis will be included.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
5mo left

Started Feb 2024

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress86%
Feb 2024Jan 2027

First Submitted

Initial submission to the registry

July 10, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 27, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

February 12, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

June 20, 2024

Status Verified

February 1, 2024

Enrollment Period

2.6 years

First QC Date

July 10, 2023

Last Update Submit

June 17, 2024

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • Plasma endotoxin levels

    Plasma endotoxin levels

    Measured 3 days after randomisation

Secondary Outcomes (15)

  • Mortality

    During the whole study period including follow-up of 90 days

  • Infectious complications

    During the whole study period including follow-up of 90 days

  • (New onset) transient/persistant (multiple) organ failure

    During the whole study period including follow-up of 90 days

  • Disease severity according to the revised Atlanta Classification

    During the whole study period including follow-up of 90 days

  • (Peri-)pancreatic necrosis

    During the whole study period including follow-up of 90 days

  • +10 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Micro-encapsulated tributyrin granules, 4 grams three times daily, for a maximum of 14 days

Dietary Supplement: Micro-encapsulated granules of tributyrin (intervention)

Control group

PLACEBO COMPARATOR

Micro-encapsulated sunflower oil granules, 4 grams three times daily, for a maximum of 14 days

Dietary Supplement: Micro-encapsulated granules of sunflower oil (placebo)

Interventions

Micro-encapsulated granules of tributyrin (intervention)DIETARY_SUPPLEMENT

Three times daily 4 grams of micro-encapsulated granules of tributyrin, for a maximum of 14 days

Intervention group
Micro-encapsulated granules of sunflower oil (placebo)DIETARY_SUPPLEMENT

Three times daily 4 grams of micro-encapsulated granules of sunflower oil, for a maximum of 14 days

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First episode of acute pancreatitis (AP)
  • Able to read and/or understand the study procedures
  • Able to give informed consent (or their legal representatives)
  • \<24 hours after diagnosis of AP
  • \<72 hours after onset of symptoms of AP

You may not qualify if:

  • Pancreatitis due to endoscopic retrograde cholangiopancreatography (ERCP), malignancy or trauma
  • Post-operative pancreatitis
  • Intra-operative diagnosis
  • Immunocompromised patients (history or current immunosuppressive treatment such as chemotherapy, radiotherapy, longer use of immunosuppressive medication or recent high doses, immunocompromised illness' such as AIDS, leukemia, lymphoma)
  • Pregnancy and/or lactation
  • Age \<18 years old
  • History of recurrent or chronic (MANNHEIM criteria25) pancreatitis (see Appendix 15.1 for definition)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Reinier de Graaf Gasthuis

Delft, South Holland, 2625AD, Netherlands

NOT YET RECRUITING

St. Antonius Hospital

Nieuwegein, Utrecht, 3435CM, Netherlands

RECRUITING

MeSH Terms

Conditions

Pancreatitis

Interventions

Methods

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • H. C. van Santvoort, dr. prof.

    St. Antonius Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Pauw, MD

CONTACT

0883207051ha.pauw@antoniusziekenhuis.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr. prof.

Study Record Dates

First Submitted

July 10, 2023

First Posted

November 27, 2023

Study Start

February 12, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

June 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)