NCT07375186

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Apr 2026Jul 2027

First Submitted

Initial submission to the registry

January 3, 2026

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 3, 2026

Last Update Submit

January 21, 2026

Conditions

Keywords

Oral Carbohydrates in Acute PancreatitisEarly feeding choice in Acute PancreatitisClear liquid diet in Acute Pancreatitis

Outcome Measures

Primary Outcomes (2)

  • rate of feeding intolerance

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

    Upto 24 hours after initiating first oral feed

  • Length of hospital Stay

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

    From hospital admission to discharge in days

Study Arms (2)

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.

Dietary Supplement: Oral Carbohydrate Solution

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.

Dietary Supplement: Clear Liquid diet

Interventions

Oral Carbohydrate SolutionDIETARY_SUPPLEMENT

Participant will be allocated in oral carbohydrate solution 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.

ORAL CARBOHYDRATE SOLUTION GROUOP
Clear Liquid dietDIETARY_SUPPLEMENT

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.

CLEAR LIQUID DIET GROUP

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital Lahore

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Surgeon

Study Record Dates

First Submitted

January 3, 2026

First Posted

January 29, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

January 29, 2026

Record last verified: 2026-01

Locations