Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Other)

Overall Status

Completed

CT.gov ID

NCT01135628

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Hepatic encephalopathy is a serious complication of cirrhosis which relays under the burden of diseases with therapeutical difficulties for its given morbidity and mortality and the high recurrence it poses. Its treatment remains a challenge for most of the cases. Even more, minimal hepatic encephalopathy is an entity that has an additional morbidity for it being a subclinical entity. As so, the investigators propose an auxiliary treatment for the management of such patients with minimal hepatic encephalopathy, using a specific diet consisting on hyperproteic and fibre-rich foods along with two independent interventions, whether a probiotic, lactobacillus reuteri, or a drug, nitozoxanide, so to diminish the rate of progression to any clinical stage of hepatic encephalopathy and to revert minimal hepatic encephalopathy itself to none hepatic encephalopathy.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Cirrhosis Minimal Hepatic Encephalopathy	Other: Auxiliary Treatment Dietary Supplement: Hyperproteic and fiber-rich diet Drug: Nitazoxanide	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Hyperproteic and Fiber-rich Diet Plus Probiotics (Lactobacillus Reuteri) and Nitazoxanide in the Treatment of Minimal Hepatic Encephalopathy.

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: MHE and diet plus lactobacillus reuteri Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and lactobacillus reuteri.	Other: Auxiliary Treatment Lactobacillus reuteri, 1 tablet bid, each of 100,000,000 FCU for 6 months Other Names: Biogaia Probiotics Dietary Supplement: Hyperproteic and fiber-rich diet Hyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet
Active Comparator: MHE and diet Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods.	Dietary Supplement: Hyperproteic and fiber-rich diet Hyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet
Active Comparator: MHE and diet plus nitazoxanide Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and nitazoxanide.	Dietary Supplement: Hyperproteic and fiber-rich diet Hyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet Drug: Nitazoxanide Nitazoxanide tablets 400 mg, bid, orally for 6 months

Arm

Intervention/Treatment

Active Comparator: MHE and diet plus lactobacillus reuteri

Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and lactobacillus reuteri.

Other: Auxiliary Treatment

Lactobacillus reuteri, 1 tablet bid, each of 100,000,000 FCU for 6 months

Other Names:

Biogaia

Probiotics

Dietary Supplement: Hyperproteic and fiber-rich diet

Hyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet

Active Comparator: MHE and diet

Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods.

Dietary Supplement: Hyperproteic and fiber-rich diet

Hyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet

Active Comparator: MHE and diet plus nitazoxanide

Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and nitazoxanide.

Dietary Supplement: Hyperproteic and fiber-rich diet

Hyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet

Drug: Nitazoxanide

Nitazoxanide tablets 400 mg, bid, orally for 6 months

Outcome Measures

Primary Outcome Measures

Reverse minimal hepatic encephalopathy [3 months]
Reverse minimal hepatic encephalopathy to none evidence of hepatic encephalopathy
Reverse minimal hepatic encephalopathy [6 months]
Reverse minimal hepatic encephalopathy to none evidence of clinical hepatic encephalopathy

Secondary Outcome Measures

Prevention of progression [3 months]
Prevention of progression from minimal hepatic encephalopathy to any clinical stage of West Haven score of hepatic encephalopathy.
Prevention of progression [6 months]
Prevention of progression from minimal hepatic encephalopathy to any clinical stage of West Haven score of hepatic encephalopathy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Hepatic Cirrhosis
Minimal hepatic Encephalopathy

Exclusion Criteria:

Personal history of surgery in the last 4 weeks
Use of neuropsychiatric drugs
Neuropsychiatric disorders (Schizophrenia, bipolar disorder, major depression, dementia and Attention-deficit hyperactivity disorder)
Thyroid disorders without replacement therapy
Hepatic or renal transplant
Alcoholism with active ingest of alcohol in the last 6 months
Pregnancy
Labour turn-overs
Spontaneous bacterial Peritonitis
Personal history of hepatocellular carcinoma
Placement of transjugular intrahepatic portosystemic shunt
Use of a probiotic in the last 6 months