Early Oral Carbohydrate Solution vs Clear Liquid Diet in Acute Pancreatitis

Jinnah Hospital

Status: Begins enrollment in 1 month

Conditions: Acute Pancreatitis

Treatments: Dietary Supplement: Clear Liquid diet; Dietary Supplement: Oral Carbohydrate Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT07375186

ERB198/07/01-0-1-2026/AIMC/JHL

Details and patient eligibility

About

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.

Enrollment: 276 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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276 participants in 2 patient groups

ORAL CARBOHYDRATE SOLUTION GROUOP

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Oral Carbohydrate Solution

CLEAR LIQUID DIET GROUP

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Clear Liquid diet