Hepatic Encephalopathy Clinical Trial
Official title:
Comparative Study Between Vegetable Proteins, and Mixed Animal Proteins on the Outcome of Hepatic Encephalopathy Patients in ICU and Wards
Vegetables are thought to be beneficial not only because of their high content of fiber, which promotes bacterial fermentation and decreases colonic transit time, decreasing ammonia absorption from the gut, but also because of their high BCAA content, low methionine and tryptophan contents, and the induction of gut microbiota which, in turn, increases fecal nitrogen excretion. Also the fact supporting the underlying rationale for the use of vegetable proteins is that dietary fiber contributes to the improvement of glycemic control in these patients. Smaller sample studies also support the idea that vegetable based protein diets have better effect on cognition in patients with HE; in these studies vegetable protein diet was compared to meat protein diet and patients with HE showed improvement in cognition on former diets. However, no positive effects were shown by Shaw or Chiarino. Similarly, another older single blind crossover study (n=10) showed that as compared to meat proteins, vegan diet has a better effect on mental status as determined on psychometric testing in patients with HE. As a result of the limited studies and small number of participants of the effect of vegetable proteins on HE, the purpose of this study is to investigate the effects of a vegetable versus mixed animal and vegetable protein diet on hepatic encephalopathy.
After approval by NHTMRI-IRB Ethical Committee.All demographic data will be obtained including the patients age, sex,associated co-morbidities (diabetes mellitus & hypertension), cause of hepatic encephalopathy, grade of hepatic encephalopathybythe West Haven criteria (WHC),14Child-Pugh score, Model for end stage liver disease (MELD) score, and subjective global assessment (SGA). All patients will receive the routine medical supportive treatment of hepatic encephalopathy in the form of rectal enemas, oral non-absorbable disaccharides (Lactulose), non-absorbable antibacterial (Rifaximin). All patients will receive enteral nutrition either oral if tolerated (HE grade I/II) or through nasogastric tubes (if intolerant; HE grade III/IV). Patients were assessed for 24 hours for tolerance of enteral feeding. Patients were randomized to receiveeither diets containingpure vegetable proteins (a study group) versus the mixed animal and vegetable proteins in the standard ratio (2/3:1/3; 60%:40% respectively) present in the nutritional menu over all hospitals in the general organization of teaching hospitals and institutes "GOTHI"; Egypt= as a control group) and continued for at least 48hours and followed for five days. The vegetable diets will be prepared from the dietetic service of our institute;calories will be calculated for 30Kcal/Kg/day (average 2000Kcal) and proteins 1.2g/Kg/day15 (average 84gm). Follow up daily for the degree of hepatic encephalopathy by WHC criteria will be recorded.Complete blood counts, urea, and blood glucose will be monitored in the first 72hours. Follow up arterial ammonia will e on day zero (start of regimen) and day three. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01846806 -
The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy.
|
N/A | |
Completed |
NCT01559519 -
Post Transjugular Intrahepatic Portosystemic Shunt (Tips) Albumine Infusion to Prevent Hepatic Encephalopathy
|
Phase 4 | |
Recruiting |
NCT01178372 -
Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis
|
Phase 4 | |
Completed |
NCT00740142 -
Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy
|
Phase 4 | |
Completed |
NCT00914056 -
A Study of Controlled Lactulose Withdrawal
|
N/A | |
Completed |
NCT00558038 -
Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy
|
Phase 2 | |
Completed |
NCT00986895 -
A Study of Glyceryl Tri-(4-phenylbutyrate) Administered Orally as a Single Dose, and Twice Daily for Seven Consecutive Days to Subjects With Hepatic Impairment With Cirrhosis and to a Control Group
|
Phase 1 | |
Completed |
NCT00287235 -
Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)
|
N/A | |
Recruiting |
NCT05539027 -
Efficacy of L-Ornithine L-Aspartate (LOLA) as an Adjunct to Branched Chain Amino Acids (BCAA) Enriched Solutions on Clinical Outcomes in ICU Patients With Hepatic Encephalopathy
|
Phase 4 | |
Recruiting |
NCT04096014 -
Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy
|
N/A | |
Completed |
NCT05526404 -
Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration
|
N/A | |
Completed |
NCT04082780 -
Rifamycin in Minimal Hepatic Encephalopathy
|
Phase 2 | |
Enrolling by invitation |
NCT06367127 -
Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening
|
||
Active, not recruiting |
NCT05425316 -
Speech in Hepatic Encephalopathy (HE)
|
||
Recruiting |
NCT04415294 -
Flicker App for Minimal Hepatic Encephalopathy
|
||
Not yet recruiting |
NCT06072521 -
Efficacy of Lactoferrin as an Adjunct Therapy in Patients With Hepatic Encephalopathy
|
Phase 2 | |
Withdrawn |
NCT02086825 -
A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Renal Failure
|
Phase 3 | |
Completed |
NCT02636647 -
Fecal Transplant in Recurrent Hepatic Encephalopathy
|
Phase 1 | |
Completed |
NCT01446523 -
S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE
|
N/A | |
Completed |
NCT01218568 -
Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial
|
N/A |