Elemental Diet for Chronic Pancreatitis

(PEACE-CP Trial)

AL
Overseen ByAndrea Leung
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an elemental diet, a special liquid diet, suits people with chronic pancreatitis experiencing bothersome stomach issues. Made from easily absorbable ingredients, participants will follow this diet strictly for two weeks. The main goal is to determine if participants can adhere to the diet and consume most of the formula. It targets adults with chronic pancreatitis who have experienced significant stomach problems in the past month. Participants will track their symptoms and diet throughout the trial. As an unphased trial, it offers a unique opportunity for patients to contribute to research that could enhance dietary management for chronic pancreatitis.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, since active infection or recent antibiotic use is an exclusion criterion, it's possible that some medications might need to be paused. Please consult with the trial coordinators for specific guidance.

What prior data suggests that this elemental diet is safe for adults with chronic pancreatitis?

Research has shown that the palatable elemental diet is generally easy for people with digestive issues to handle. In studies, patients have experienced positive outcomes without serious side effects. For instance, one study found that this diet improved participants' quality of life due to its easy digestibility. Another study noted that all participants adhered to the diet plan, indicating it is manageable for most people.

Additionally, the diet has been successfully used for conditions like small intestinal bacterial overgrowth (SIBO) and other gut problems. These studies did not report any major negative effects, suggesting that serious side effects are uncommon. This indicates that the palatable elemental diet is safe for most people. However, as with any treatment, individual experiences may vary, and discussing any concerns with a healthcare provider is always important.12345

Why are researchers excited about this trial?

Most treatments for chronic pancreatitis focus on managing pain and digestive issues with enzyme supplements and pain relievers. Unlike these standard therapies, the palatable elemental diet offers a more holistic approach by simplifying digestion to help the pancreas rest and heal. This diet consists of easily absorbable nutrients, potentially reducing inflammation and pain more quickly. Researchers are excited about this treatment because it could offer a non-invasive alternative that targets the root of the problem rather than just alleviating symptoms.

What evidence suggests that this palatable elemental diet might be an effective treatment for chronic pancreatitis?

Research has shown that elemental diets can help reduce pain for people with chronic pancreatitis. In one study, 88% of patients experienced less pain after following a low-fat elemental diet. Another study found that this diet could improve quality of life by easing gut symptoms. Elemental diets are effective because they contain easily digestible ingredients, which can be gentle on the stomach. They have also reduced symptoms like stomach pain and bloating by up to 82% in other digestive conditions. Participants in this trial will consume a palatable elemental diet exclusively for 14 days to evaluate its effects on chronic pancreatitis symptoms.23467

Who Is on the Research Team?

YJ

Yi Jiang, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 75 who have been diagnosed with chronic pancreatitis and are experiencing significant ongoing digestive symptoms. Participants must have had bothersome gastrointestinal issues in the past month.

Inclusion Criteria

I am between 18 and 75 years old.
I have been diagnosed with chronic pancreatitis.
I have had significant digestive symptoms from chronic pancreatitis in the past month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume an exclusive oral palatable elemental diet for 14 days, complete daily diet and symptom diaries, and undergo study assessments including questionnaires and biospecimen collection

2 weeks
Daily self-reporting and assessments

Follow-up

Participants resume their usual diet and continue follow-up for safety and effectiveness monitoring

4 weeks
Assessments at Day 28 and Day 56

What Are the Treatments Tested in This Trial?

Interventions

  • Palatable Elemental Diet

Trial Overview

The study is testing whether a special, easy-to-digest liquid diet (elemental diet) can be followed exclusively for two weeks by people with chronic pancreatitis and if it helps manage their stomach symptoms.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Palatable Elemental DietExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Cedars-Sinai Medical Center

Collaborator

Trials
523
Recruited
165,000+

mBIOTA

Collaborator

Citations

Beneficial Effect of Low-Fat Elemental Diet Therapy on Pain in ...

At 8 weeks, pain alleviation after low-fat ED therapy was reported in 15 out of 17 patients (88%). Of these 15 patients, 10 patients reported complete pain ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/24622078/

Effects of oral ingestion of the elemental diet in patients ...

An oral low-fat elemental diet composed of purified amino acids, which requires no special treatment procedures, may improve patients' quality of life.

Effect, Tolerability, and Safety of Exclusive Palatable ...

Elemental diets (EDs) have desirable safety and efficacy profiles in several clinical settings partly because of modulation of gut microbiome.

Effect, Tolerability, and Safety of Exclusive Palatable ...

We aimed to assess the effect, tolerance, and safety of a novel palatable ED (PED) in subjects with IMO and/or SIBO.

Ali Rezaie, MD: Exploring a Palatable Approach to ...

In an interview with HCPLive, he highlighted the 100% completion rate in the trial and the fact that 73% of patients objectively normalized ...

Palatable Elemental Diet for Gastrointestinal Symptoms in ...

The goal of this clinical trial is to learn whether a 2-week exclusive palatable elemental diet is feasible, tolerable, and acceptable for ...

Elemental Diet for Chronic Pancreatitis (PEACE-CP Trial)

The goal of this clinical trial is to learn whether a 2-week exclusive palatable elemental diet is feasible, tolerable, and acceptable for adults with ...