- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07375186
Early Oral Carbohydrate Solution vs Clear Liquid Diet in Acute Pancreatitis
Comparison of Oral Carbohydrate Solution Versus Clear Liquid Diet in Acute Pancreatitis:A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr. Aiqa Gulshan
- Phone Number: +923219559294
- Email: aiqagulshan7080@gmail.com
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan
- Jinnah Hospital Lahore
-
Contact:
- Jinnah hospital Lahore
- Phone Number: (042) 99231480
- Email: info@aimc.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ORAL CARBOHYDRATE SOLUTION GROUOP
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.
|
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.
|
|
Active Comparator: CLEAR LIQUID DIET GROUP
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
rate of feeding intolerance
Time Frame: 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.
|
Upto 24 hours after initiating first oral feed
|
|
Length of hospital Stay
Time Frame: From hospital admission to discharge in days
|
Length of hospital stay will be recorded from day of admission till discharge in days.
|
From hospital admission to discharge in days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERB198/07/01-0-1-2026/AIMC/JHL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Pancreatitis
-
Centre Hospitalier Universitaire de NiceCompleted
-
Changhai HospitalRecruitingAcute Pancreatitis | Severe Acute PancreatitisChina
-
Assistance Publique - Hôpitaux de ParisRecruiting
-
John Gasdal KarstensenCompleted
-
Peking Union Medical College HospitalBeijing Longfu Hospital; Beijing Sixth HospitalRecruitingSevere Acute Pancreatitis | Acute Pancreatitis (AP)China
-
Tianjin Nankai HospitalCompletedAcute PancreatitisChina
-
Xiangya Hospital of Central South UniversityThe Affiliated Hospital Of Guizhou Medical University; LiuZhou People's HospitalNot yet recruitingInfected Pancreatic Necrosis | Acute Necrotizing Pancreatitis
-
Mayo ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedAcute Pancreatitis (AP) | Gallstone Pancreatitis | Alcoholic Pancreatitis | Trauma Acute Pancreatitis | Hypertriglyceridemia Acute Pancreatitis | Idiopathic (Unknown) Acute Pancreatitis | Medication Induced Acute Pancreatitis | Cancer Acute Pancreatitis | Miscellaneous (i.e. Acute on Chronic Pancreatitis)United States
-
Northern State Medical UniversityCompleted
-
Erzhen ChenRenJi HospitalUnknownPancreatitis,Acute NecrotizingChina
Clinical Trials on Oral Carbohydrate Solution
-
Nevsehir Haci Bektas Veli UniversityCompletedFasting | Hip Arthropathy | Patient ComfortTurkey
-
Indonesia UniversityRecruiting
-
Istanbul Sureyyapasa Chest Diseases and Chest Surgery...CompletedNon Small Cell Lung Cancer | Fasting | Postoperative PneumoniaTurkey
-
Marmara UniversityCompletedPostoperative Nausea and Vomiting | Bariatric SurgeryTurkey
-
Gia Dinh People HospitalCompletedFasting | Gastric Emptying | Type2diabetes | Carbohydrate Loading | Enhanced Recovery After Surgery (ERAS)Vietnam
-
Eunah Cho, MDCompletedGeneral AnesthesiaKorea, Republic of
-
Cairo UniversityNot yet recruitingPostoperative Nausea and Vomiting
-
Medical University of WarsawRecruitingEnd Stage Liver Disease | Liver Transplantation | Liver Transplant | Liver Transplant SurgeryPoland
-
Yonsei UniversityUnknown
-
University Hospital, CaenRecruitingPregnancy Related | Delivery Complication | Labor LongFrance