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临床试验/NCT02538146
NCT02538146终止早期 1 期

Acetyl-L-carnitine as Pain Therapy in Chronic Pancreatitis

Karin High2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
早期 1 期
状态
终止
发起方
入组人数
3
试验地点
2
主要终点
Pain score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Only patients with chronic pancreatitis are included.

排除标准

  • 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.

结局指标

主要结局

Pain score

时间窗: 3 months

McGill short form Visual Analogue Scale (VAS scale) 1 normal 2-10 pain level

次要结局

  • Well Being(3 months)
  • Generalized anxiety disorder 7-item (GAD-7) Scoring(3 months)
  • Inflammatory Markers(3 months)
  • Patient Depression Questionnaire Scoring(3 months)

研究者

发起方
Karin High
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Karin High

Professor

University of Kentucky

研究点 (2)

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