Vegetarian Versus Non Vegetarian Based Diet in the Recurrence of Hepatic Encephalopathy in Patients With Cirrhosis: An Open Label Pilot Study

NCT06328088 | Recruiting DMC

• 1 other identifier: EC/12/23/2400
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Earlier protein restriction was advocated in the treatment of HE but later this concept was refuted and increase protein intake was advocated in patients with HE. Diet in patients during an episode HE is also not known. It is advisable based on many case reports or case series that vegetable-based diet during the episode of HE is better than animal-based diet as it reduces ammonia level and other false neurotransmitters in brain and helps in early recovery of, HE . However, diet in patients who had recovered from an episode of, HE is not known and what type of protein (vegetarian or non-vegetarian) should be taken to prevent another episode of HE has never been evaluated. In India majority of the patients are vegetarian and patients with cirrhosis are malnourished and lack protein in their diet as per our previous published study

Conditions

Hepatic Encephalopathy

Keywords

Hepatic encephalopathy;diet;vegetarian;non vegetarian;cirrhosis

Outcome Measures

Primary Outcomes (1)

• Recurrence of overt hepatic encephalopathy

  6 month follow up

Secondary Outcomes (1)

• Hospitalization due to any cause

  six month

Study Arms (2)

Non vegetarian diet

Non vegetarian diet

Dietary Supplement: Non vegetarian

Vegetarian diet

Vegetarian diet

Dietary Supplement: Non vegetarian

Interventions

Non vegetarian DIETARY_SUPPLEMENT

Non vegetarian diet plus supportive treatment including lactulose and/or rifaximin

Non vegetarian diet; Vegetarian diet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients of cirrhosis and hepatic encephalopathy who has completely recovered from Hepatic encephalopathy and put on secondary prophylaxis

You may qualify if:

• \- 1) Age 18 years and older. 2) Confirmed diagnosis of liver cirrhosis. (Diagnosed on the basis of clinical, biochemical, radiological or endoscopic features).
• \) Willingness to sign informed consent proforma. 4) Patients who recovered from Hepatic encephalopathy will be enrolled from Out patient Department within 15 days of discharge

You may not qualify if:

• \- 1) Patients with underlying severe cardiopulmonary disease or hepatocellular carcinoma.
• \) Patients with CTP score of more than 12 3) Patient not willing for follow up or consent to participate in the study

Sponsors & Collaborators

• Sir Ganga Ram Hospital: lead

Study Sites (1)

Sir Ganga Ram Hospital

Delhi, 110060, India

RECRUITING

MeSH Terms

Conditions

Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Praveen Sharma, MD,DM

CONTACT

9810365151; drpraveen_sharma@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: March 25, 2024
• Study Start: February 16, 2024
• Primary Completion: April 16, 2024
• Study Completion: October 16, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

IN (1)