NCT02022137

Brief Summary

As an alternative for the treatment of Minimal Hepatic Encephalopathy (MHE) Agave fructans have shown prebiotic effects, and have shown to improve function of the digestive system, control and induce glycemic effect satiety. Therefore the impact of the fermentation of such prebiotic in the gut may contribute to improving health and quality of life of patients with MHE.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 27, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

June 8, 2016

Status Verified

June 1, 2016

Enrollment Period

1.8 years

First QC Date

December 16, 2013

Last Update Submit

June 7, 2016

Conditions

Liver Cirrhosis

Keywords

Minimal hepatic encephalopathyHepatic encephalopathy

Outcome Measures

Primary Outcomes (1)

  • Minimal hepatic encephalopathy

    Assessed by psychometric Hepatic Encephalopathy (PHES) and Critical Flicker Frequency (CFF)

    2 months

Secondary Outcomes (1)

  • Nutritional Status

    2 months

Other Outcomes (1)

  • Ammonia, liver function tests

    baseline and 2 months

Study Arms (3)

Red cereal bar

EXPERIMENTAL

It includes the intervention of the red cereal bar for the designation of the group.

Dietary Supplement: Red cereal bar

Green cereal bar

PLACEBO COMPARATOR

It includes the intervention of the green cereal bar for the designation of the group.

Dietary Supplement: Green cereal bar

White cereal bar

ACTIVE COMPARATOR

It includes the intervention of the white cereal bar for the designation of the group.

Dietary Supplement: White cereal bar

Interventions

Red cereal barDIETARY_SUPPLEMENT

Consumption of the cereal bar with agave fructans or lactitol or lactose added each bar with 10 grams of dietary fiber and 1.2 grams of protein by weight and 20 to 30 grams of fiber.

Red cereal bar
Green cereal barDIETARY_SUPPLEMENT

Consumption of the cereal bar with agave fructans or lactitol or lactose added each bar with 10 grams of dietary fiber and 1.2 grams of protein by weight and 20 to 30 grams of fiber.

Green cereal bar
White cereal barDIETARY_SUPPLEMENT

Consumption of the cereal bar with agave fructans or lactitol or lactose added each bar with 10 grams of dietary fiber and 1.2 grams of protein by weight and 20 to 30 grams of fiber.

White cereal bar

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 to 70 years.
  • Liver cirrhosis of any etiology.
  • Presence of minimal hepatic encephalopathy.
  • Presence of hepatic encephalopathy I

You may not qualify if:

  • Hepatic encephalopathy II or III
  • Use of antibiotics in the previous month.
  • Presence of immunological diseases.
  • Consumption of probiotics.
  • Patients with hepato-renal diseases.
  • Patients who do not agree to participate in the project.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

México, D.f., 1400, Mexico

Location

MeSH Terms

Conditions

Liver CirrhosisHepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsLiver FailureHepatic InsufficiencyBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Aldo Torre Delgadillo, M.D. M.Sc

    INCMNSZ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

December 16, 2013

First Posted

December 27, 2013

Study Start

October 1, 2013

Primary Completion

August 1, 2015

Study Completion

March 1, 2016

Last Updated

June 8, 2016

Record last verified: 2016-06

Locations

ME(1)