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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04760847




Registration number
NCT04760847
Ethics application status
Date submitted
15/02/2021
Date registered
18/02/2021

Titles & IDs
Public title
Intermittent Fasting for Pancreatitis
Scientific title
Intermittent Fasting as a Primary Means for Improving Quality of Life for Acute and Chronic Pancreatitis
Secondary ID [1] 0 0
STUDY20201373
Universal Trial Number (UTN)
Trial acronym
IFPanc
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatitis 0 0
Pancreatitis, Acute 0 0
Pancreatitis, Chronic 0 0
Pancreas Disease 0 0
Acute Recurrent Pancreatitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Intermittent Fasting
Other interventions - No intermittent fasting

Experimental: Intermittent Fasting - Patients in Group A will then receive information regarding intermittent fasting, which would include fasting for a 16-hour period each day, followed by ingestion of an appropriate number of calories for the remaining part of the day.

Active comparator: Control - These subjects will undergo standard caloric dietary guidance. Patients in group B will also be given the above information, though not be asked to intermittently fast.


Other interventions: Intermittent Fasting
These subjects will will then receive information regarding intermittent fasting, which would include fasting for a 16-hour period each day, followed by ingestion of an appropriate number of calories for the remaining part of the day. See attached IF Quick Facts for details provided to the patient.

Other interventions: No intermittent fasting
These subjects will undergo standard caloric dietary guidance. Patients in group B will also be given the above information, though not be asked to intermittently fast
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pancreas related Quality of Life Index (PANQALI)
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
Pain scores
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
Oral Morphine Equivalent Daily Dosing
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
Patient weight
Timepoint [3] 0 0
24 weeks
Secondary outcome [4] 0 0
Patient Body mass index
Timepoint [4] 0 0
24 weeks
Secondary outcome [5] 0 0
Vitamin D 25-OH levels
Timepoint [5] 0 0
24 weeks
Secondary outcome [6] 0 0
stool pancreatic elastase levels
Timepoint [6] 0 0
24 weeks
Secondary outcome [7] 0 0
Readmissions
Timepoint [7] 0 0
24 weeks
Secondary outcome [8] 0 0
Length of Stay
Timepoint [8] 0 0
24 weeks

Eligibility
Key inclusion criteria
* Age = 18 year
* Recurrent acute pancreatitis defined by greater than 2 episodes of pancreatitis, defined by:

abdominal pain and either amylase or lipase > 3 x the upper limit of normal, imaging suggestive of, separated by time

* Anatomy of chronic pancreatitis defined by Rosemont criterion9 or on imaging (CT, MRI)
* Pancreatic exocrine insufficiency defined by a pancreatic elastase < 200 ug/g stool10
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Age < 18 years
* Pregnant Patients
* Age > 80 years
* Patients who cannot consent for themselves
* Glycogen storage disease
* Insulinoma or hypoglycemic state
* Active alcohol abuse
* Alcohol induced acute pancreatitis
* Gallstone induced acute pancreatitis
* Pancreatic solid neoplasm
* Patients with diabetes
* Patients on beta blockers

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida

Funding & Sponsors
Primary sponsor type
Other
Name
H. Lee Moffitt Cancer Center and Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shaffer Mok
Address 0 0
Country 0 0
Phone 0 0
6099804564
Fax 0 0
Email 0 0
mok.shaffer@gmail.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04760847