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临床试验/NCT07375186
NCT07375186尚未招募不适用

Comparison of Oral Carbohydrate Solution Versus Clear Liquid Diet in Acute Pancreatitis:A Randomized Controlled Trial

Jinnah Hospital1 个研究点 分布在 1 个国家目标入组 276 人开始时间: 2026年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
276
试验地点
1
主要终点
rate of feeding intolerance

研究概览

简要总结

Background:

Acute pancreatitis (AP) is an inflammatory condition associated with increased metabolic demands and negative nitrogen balance, making early nutritional support a critical component of management. Concentional practice favored prolonged fasting and delayed oral intake; however, recent evidence supports early oral feeding. Oral carbohydrate solutions (OCS) may provide early caloric support with minimal pancreatic stimulation, but data comparing OCS with clear liquid (CL) diets which is current practice remain limited, particularly in South Asian populations.The Convential diet (CD )group started at liquid diet then progressed towards soft and then solid diet experienced recurring pain at a considerably higher rate than the oral high carbohydrate solution (OCS )group providing essential calories,(13.2% vs. 3.8%, p < 0.001).OCS showed decrease rate of post prandial recurrent abdominal pain.

Objective:

To compare oral carbohydrate solution versus clear liquid diet as the initial oral feeding strategy in patients with acute pancreatitis, focusing on feeding intolerance and length of hospital stay.

Methods:

This prospective randomized controlled trial will be conducted at a tertiary-care hospital in Lahore, Pakistan. Adult patients (18-70 years) with mild to moderately severe acute pancreatitis will be randomized to receive either an oral carbohydrate solution (10% dextrose in water) or a clear liquid diet as the initial oral feed. The primary outcomes will be feeding intolerance within 24 hours and length of hospital stay. Secondary outcomes include time to successful oral feeding, time to soft diet, changes in pain scores, inflammatory markers (CRP, WBC), glycemic response, need for nutritional escalation, complications, and patient satisfaction. Data will be analyzed using SPSS version 26, with a p-value ≤ 0.05 considered statistically significant.

Conclusion:

If proven safe and effective, oral carbohydrate solution may serve as a simple, cost-effective and well-tolerated alternative to clear liquid diets for early oral feeding in acute pancreatitis, particularly in resource limited settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age range between 18 years and 70 years
  • Diagnosis of mild or moderately severe acute pancreatitis
  • Hemodynamically stable
  • Able to tolerate oral intake
  • Provided written informed consent

排除标准

  • Severe acute pancreatitis
  • Chronic pancreatitis
  • Pregnancy
  • Uncontrolled diabetes mellitus
  • Known malabsorption syndrome,
  • Patients requiring immediate enteral tube feeding or parenteral nutrition,
  • Known allergy or intolerance to carbohydrate solutions,
  • Persistent retching or vomiting

研究组 & 干预措施

ORAL CARBOHYDRATE SOLUTION GROUOP

Experimental

Participant will be randomized in this group. Participant will receive an oral carbohydrate solution initiated after clinical stabilization.It will be be administrated orally with volume and frequency standardized for all participants and advancement according to study protocol.

干预措施: Oral Carbohydrate Solution (Dietary Supplement)

CLEAR LIQUID DIET GROUP

Active Comparator

Participant will receive a standard clear liquid diet initiated after clinical stabilization as per routine institutional practice in measured frequncy and volume and advancement according to study protocol.

干预措施: Clear Liquid diet (Dietary Supplement)

结局指标

主要结局

rate of feeding intolerance

时间窗: Upto 24 hours after initiating first oral feed

Patient will be observed for 24 hours after initial feed for symptoms of feeding intolerance like pain,nausea,vomiting or abdominal distension.

Length of hospital Stay

时间窗: From hospital admission to discharge in days

Length of hospital stay will be recorded from day of admission till discharge in days.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aiqa Gulshan

Resident Surgeon

Jinnah Hospital

研究点 (1)

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