Effect of Acetyl-L-carnitine on Chronic Pancreatitis

Study Overview
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Brief Summary
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An open label pilot study will determine the effect of the amino acid nutritional supplement acetyl-L-carnitine (ALC) on pain, quality of life, well-being, and serum pro-inflammatory mediator and oxidative stress levels in volunteers with chronic pancreatitis. The ALC is given to all participants for 3 months, and assessments will occur at intake and after 3 months.

Detailed Description
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This is an open label pilot study to determine the effect of the amino acid nutritional supplement acetyl-L-carnitine (ALC) on chronic pancreatitis. ALC is an acetylated form of naturally occurring amino acid L-carnitine ((R)-3-Acetyloxy-4-trimethylammonio-butanoate) found in red meat and is readily commercially available. Supplementation with ALC may decrease pain and improve overall health based on our preclinical treatment studies in rats with high fat and alcohol induced pancreatitis. In rats, ALC reduces pain measures, improves glucose tolerance, decreases lipid peroxidation, and Ki67 cellular injury biomarker, and improves pancreatic histopathology. The measurable outcomes of this clinical study are patients' questionnaire scores for: pain, quality of life, well-being, and serum pro-inflammatory mediator and oxidative stress levels in volunteers with chronic pancreatitis. The questionnaires are given at intake and at experiment end (3 months). Participants will receive ALC for 3 months. These findings will indirectly determine the effect of ALC on the function and inflammatory state of the pancreas. Currently, there is no specific therapy for chronic pancreatitis, and its pathophysiology is still poorly understood. It is known that chronic pancreatitis is caused by ongoing inflammation in the pancreas, yet, no pharmacological intervention exists that optimally addresses this. The broad actions of ALC as an antioxidant and anti-inflammatory agent as well as its ability to reduce side-effects of alcohol cessation make it a perfect compound to pursue for the treatment of pancreatitis.

Official Title
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Acetyl-L-carnitine as Pain Therapy in Chronic Pancreatitis

Conditions
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Chronic Pancreatitis

Intervention / Treatment
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* Dietary Supplement: acetyl-L-carnitine 1000mg 2X per day for 3 months


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Only patients with chronic pancreatitis are included. Exclusion Criteria: Patients with pancreatic pseudocysts, abscesses, pseudoaneurysms, pancreatitic fistulas, pancreatic adenocarcinoma, Females that are pregnant or lactating Children are excluded. Patients suffering from seizure or thyroid disorders are also excluded due to possible exaggeration of their symptoms from taking ALC according to manufacturer.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Acetyl-L-carnitine 1000mg 2X per day for 3 months | Dietary Supplement: acetyl-L-carnitine 1000mg 2X per day for 3 months<br>* non-essential dietary amino acid<br>* Other names: ALC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | McGill short form Visual Analogue Scale (VAS scale) 1 normal 2-10 pain level | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Well Being | Normal: 0 of 30 days with major impairment; 30 of 30 days feeling very healthy and full of energy | 3 months | 
| Generalized anxiety disorder 7-item (GAD-7) Scoring | 5-< 10 Mild Anxiety 10-<15 Moderate Anxiety >15 Severe Anxiety 5-< 10 Mild Anxiety 10-<15 Moderate Anxiety >15 Severe Anxiety 5-< 10 Mild Anxiety 10-<15 Moderate Anxiety >15 Severe Anxiety 5-< 10 Mild Anxiety; 10-<15 Moderate Anxiety; >15 Severe Anxiety | 3 months | 
| Patient Depression Questionnaire Scoring | 5-<10 Mild Depression; 10-<15 Moderate Depression; 15-<20 Moderately Severe Depression; >20 Severe Depression | 3 months | 
| Inflammatory Markers | TBARS: in fasted (8 hrs) 4.7±0.2 μmol/l blood serum; TGFbeta1: 20-50 pg/ml; PDGF: 20-30 pg/ml | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, depression, cytokines, well-being