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Intermittent Fasting for Pancreatitis (IFPanc Trial)

N/A

Waitlist Available

Research Sponsored by University Hospitals Cleveland Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Patients with diabetes

Age < 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing intermittent fasting to help people with recurrent acute and chronic pancreatitis. The fasting process releases fatty acids that turn into ketones, providing energy and reducing inflammation and scarring in the pancreas.

Who is the study for?

This trial is for adults aged 18 to 80 with recurrent acute pancreatitis or chronic pancreatitis, confirmed by specific diagnostic criteria. It's not suitable for pregnant individuals, those unable to consent, patients with certain types of pancreatitis (alcohol or gallstone-induced), pancreatic cancer, diabetes, on beta blockers, under 18 years old, with glycogen storage disease or active alcohol abuse.

What is being tested?

The study aims to see if intermittent fasting can improve life quality and reduce hospital visits compared to a standard diet in people with pancreas-related diseases. Participants will be assigned either to try intermittent fasting or continue their usual diet.

What are the potential side effects?

Potential side effects from intermittent fasting may include hunger pangs, fatigue, headaches and dizziness especially early on as the body adjusts. Long-term effects are still being studied but could impact blood sugar levels and metabolism.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have had more than 2 episodes of severe pancreatitis.

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My chronic pancreatitis is confirmed by specific tests or scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes.

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I am under 18 years old.

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I am currently taking beta blockers.

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I have a solid tumor in my pancreas.

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My acute pancreatitis was caused by alcohol.

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I have acute pancreatitis caused by gallstones.

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I am unable to give consent for my own medical treatment.

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I have insulinoma or experience low blood sugar levels.

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I have been diagnosed with a glycogen storage disease.

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I am over 80 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pancreas related Quality of Life Index (PANQALI)

Secondary study objectives

Length of Stay

Oral Morphine Equivalent Daily Dosing

Pain scores

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intermittent FastingExperimental Treatment1 Intervention

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.

Group II: ControlActive Control1 Intervention

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.

0 / 13Eligibility criteria met