An interventional study of mixed animal and vegetable proteins and pure vegetable proteins in Hepatic Encephalopathy, sponsored by National Hepatology & Tropical Medicine Research Institute. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-26.
Sponsored by National Hepatology & Tropical Medicine Research Institute · Not applicable, Interventional, and Supportive care
Among 14 studies in Hepatic Encephalopathy with a site in Egypt — 5 open to participants now, 5 under way, 1 of them phase 3. Hepatic Encephalopathy · Egypt.
Among the 14 studies in Hepatic Encephalopathy with a site in Egypt, this one is the 2nd largest by planned enrollment of the 10 interventional ones, is one of 3 that started in 2023, is one of 2 with no phase, and was the 10th registered.
225 studies on the registry are indexed under Hepatic Encephalopathy; 53 are open to participants now.
This study's planned enrollment of 196 is above the median of 60 across 154 interventional studies indexed under Hepatic Encephalopathy.
Browse Hepatic Encephalopathy studies →5 of the 14 studies in Hepatic Encephalopathy with a site in Egypt are open now, in 1 country. Each count lists the studies.
Of the 29 Hepatic Encephalopathy studies recruiting now, 11 (38%) set no upper age limit and 13 (45%) stop at 75 or younger; 1 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →14 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 3 started in 2023.
Median enrollment 110 across the 10 interventional studies, 100 across the 4 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
None of the 14 has an industry lead sponsor. The 10 most frequent:
National Hepatology & Tropical Medicine Research Institute is the lead sponsor of 20 studies on the registry; 6 are open to participants now.
National Hepatology & Tropical Medicine Research Institute has 2 studies filed under Hepatic Encephalopathy — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Hepatic Encephalopathy with a site in Egypt, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.(average 2000Kcal) and proteins 1.2g/Kg/day15 (average 84gm).
Dietary Supplement: mixed animal and vegetable proteins
pure vegetable proteins (a study group). (average 2000Kcal) and proteins 1.2g/Kg/day15 (average 84gm).
Dietary Supplement: pure vegetable proteins
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).
pure vegetable proteins 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).
grade of hepatic encepalopathy
if the vegetable proteins will improve the hepatic encephalopathy grade in comparison with animal proteins.
Time frame: 48hours
length of stay
ICU ength of stay
Time frame: during the study up to 24 weeks
length of stay
hospital stay
Time frame: during the study up to one year
Start is estimated for Dec 2023; primary completion for Sep 2024, 9 months later.
Of 25 interventional studies with no phase under Hepatic Encephalopathy, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 72. This study's planned 9 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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National Hepatology & Tropical Medicine Research Institute