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Cirrhosis of the LiverNCT04243148

Frailty in Patients With Cirrhosis: Prognostic Value of the Phase Angle in Hospitalized Patients and Effect of Multifactorial Intervention

A study testing Home exercise program for 12 months., Multispecies probiotic: Vivomixx® and Branched-chain amino acids (BCAA) in people with Cirrhosis of the Liver and Sarcopenia, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluate Frailty syndrome (FS) as a common syndrome in patients with cirrhosis and it is an independent predictor of hospitalizations, falls and mortality. Identifying, treating and preventing FS can improve the prognosis and quality of life of these patients and reduce health costs. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Home exercise program for 12 months., Multispecies probiotic: Vivomixx® and Branched-chain amino acids (BCAA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteSpain
Study dates
13 May 2020to 30 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients
  • Aged >18 years old, with cirrhosis diagnosed by clinical, analytical and ultrasound criteria or liver biopsy
  • Conscious and oriented in time and space and able to understand and follow the indications of the study.

Who cannot join

  • Liver cirrhosis with poor prognosis (MELD [Model for End Stage Liver Disease]> 25)
  • Hepatocellular carcinoma or other active neoplastic disease
  • Expected survival <6 months
  • Acute and/or chronic hepatic encephalopathy
  • Neurological disorder that hinders the performance of the tests
  • Active alcoholism in the previous 3 months
Show all 10Show fewer
  • Severe comorbidities
  • Hospitalization in the previous month
  • Contraindications to exercise or probiotic treatment (immunosuppression)
  • Refusal to sign informed consent.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

Other trials in Spain

About this study

Official title: Frailty in Patients With Cirrhosis: Prognostic Value of the Phase Angle in Hospitalized Patients and Effect of a Multifactorial Intervention (Home Exercise, Branched-chain Aminoacids and Probiotic)

This study evaluate Frailty syndrome (FS) as a common syndrome in patients with cirrhosis and it is an independent predictor of hospitalizations, falls and mortality. Identifying, treating and preventing FS can improve the prognosis and quality of life of these patients and reduce health costs.

Read the detailed description

Substudy I. The phase angle (PA) determined by electrical bioimpedance is an index of FS with prognostic value in outpatients with cirrhosis, but its usefulness in hospitalized patients has not been studied. Objective: To analyze the prognostic value of PA in hospitalized patients with cirrhosis. Patients and Methods: 100 hospitalized patients with cirrhosis will be consecutively included and PA will be determined by bioimpedance at admission. The correlation between PA and liver function and frailty markers, and the evolution during hospitalization, as well as the incidence of falls, hospitalizations and mortality during follow-up will be analyzed. Substudy II. Given the multidimensional nature of the FS, we propose a multifactorial non-pharmacological intervention based on evidence from previous studies that could be implemented in daily clinical practice. Objective: To evaluate if a multifactorial intervention can improve the FS and decrease the related events (hospitalizations, falls and mortality) in patients with cirrhosis. Patients and Methods: 150 outpatients with cirrhosis will be included and evaluated using the Liver Frailty Index. Frail and pre-frail patients will be randomized into two groups: one group that will receive a multifactorial intervention, consisting of exercise at home, branched-chain amino acids and multispecies probiotic for one year, and one control group. The evolution of the Liver Frailty Index and other parameters (muscle and cognitive function, bioimpedance, risk of falls, quality of life) and biomarkers (miostatin, immune response, microbiota) of FS, and the incidence of hospitalizations, falls and mortality in both groups will be prospectively analyzed.

Being tested
Home exercise program for 12 months., Multispecies probiotic: Vivomixx®, Branched-chain amino acids (BCAA), No specific intervention.
Keywords
Falls, Hospitalizations, Mortality, Phase angle, Body Composition
Medical subject headings
Fibrosis, Sarcopenia, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home exercise program for 12 months.Combination product

    Physical exercise at home: At the beginning of the study, group sessions will be conducted with 5 patients of 1-hour duration, where they will be taught the individualized program according to their physical condition and they will be given the necessary material (pedaling, dumbbells and elastic bands) and paper support on the program, also using the Vivifrail method through infographics. The group session will be repeated every 3 months to check the compliance of the program by reviewing daily activity, evaluate possible problems and review the exercises. The program will consist of aerobic and anaerobic exercise by pedaling (cardiovascular resistance) and resistance exercises with dumbbells and elastic bands (muscular strength), flexibility training by stretching, and coordination and balance exercises. Patients will perform 3 sessions per week of 20-30 min. increasing progressively according to tolerance up to 45-60 min. each.

  • Multispecies probiotic: Vivomixx®Combination product

    Multispecies probiotic: Vivomixx® is a probiotic mixture of 8 bacterial strains:

    Streptococcus thermophilus DSM 24731® / NCIMB 30438, Bifidobacterium breve DSM 24732® / NCIMB 30441, Bifidobacterium longum DSM 24736® / NCIMB 30435*, Bifidobacterium infantis DSM 24737® / NCIMB 30436*, Lactobacillus acidophilus DSM 24735® / NCIMB 30442, Lactobacillus plantarum DSM 24730® / NCIMB 30437, Lactobacillus paracasei DSM 24733® / NCIMB 30439, Lactobacillus delbrueckii subsp. bulgaricus DSM 24734® / NCIMB 30440**

    • Re-classified as B. lactis ** Re-classified as L. helveticus The active agent will be supplied as an envelope of 4.4 g with a dose of 450x109 million live bacteria per envelope with maltose and silicon dioxide as excipients, administered 2 times/day throughout the study.

  • Branched-chain amino acids (BCAA)Combination product

    Branched-chain amino acids (BCAA): In addition to the exercise program and the probiotic, patients in the intervention group will receive BCAA supplements (powder in 8:1:1 ratio in favor of L-leucine) 10 g 30-60 min. before the exercise session throughout the study, in order to enhance the effect of exercise on muscle mass and improve cognitive function. We have chosen this dose based on the literature data and the satisfactory results obtained with this dose in our previous study. BCAA supplements will be supplied by the Pharmacy Service of our center.

  • No specific intervention.Combination product

    Follow up as a clinical practice

Study groups in NCT04243148
Study groupRoleWhat they receive
Multifactorial interventionExperimentalFrail and pre-frail patients will receive multifactorial intervention consisting of home exercise, BCAA supplements and a multispecies probiotic for 12 months.
Receives: Combination Product: Home exercise program for 12 months.; Combination Product: Multispecies probiotic: Vivomixx®; Combination Product: Branched-chain amino acids (BCAA)
Control groupExperimentalFrail and pre-frail patients will be followed but will not receive any specific intervention.
Receives: Combination Product: No specific intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Substudy I: Mortality during hospitalization and follow-up

    At the time of admission, during hospitalization and in one hundred outpatients visits every 3 months until 12 months of follow-up

    Measured: One year

  2. Substudy II: Evolution of the Liver Frailty Index.

    At the beginning and every 3 months in one hundred fifty outpatient visits until the end of the study at 12 months

    Measured: One year

Secondary outcomes (8)

  1. Phase angle (PA)

    By bioimpedance (BIA 101 with Bodygram Pro software, Akern) at admission, hospital discharge and every 3 months.

    Measured: One year

  2. Degree of sarcopenia

    Grip strength assessed by a dynamometer (KERN MAP 80K1, Akern). The results will be adjusted by age and gender

    Measured: One year

  3. Biomarkers of frailty

    At baseline and at 12 months.We will quantify by specific ELISA kits and multiplex assays biomarkers

    Measured: One year

  4. Fall risk tests

    Walking speed (41) and Timed Up \& Go: time in seconds that the patient uses to get up from a chair, walk 3 meters and sit back without support. Times greater than 9 seconds to travel the distance is considered a risk of falls

    Measured: One year

  5. Cognitive function

    Psychometric Hepatic Encephalopathy Score (PHES). Scores <-4 points is considered as a cognitiva impairment

    Measured: One year

  6. Degree of Quality of life

    SF-36 questionnaire

    • Scores above 50 will be better and below 50 points will be worse.

    Measured: One year

  7. Fecal microbiota

    At baseline, 6 and 12 months.For the extraction of genomic DNA from stool samples, a previous protocol according to the International consortium (IHMS: http://www.microbiome-standards.org/) will be used.

    Measured: One year

  8. Degree Quality of life

    Depression and anxiety scale (HADS): Scores higher than 11 are probably cases in each of the subscales

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2020
  2. Study start13 May 2020
  3. Primary completion30 Jun 2022
  4. Study completion30 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04243148
Sponsor's protocol ID
IIBSP-FRA-2019-36
Status last verified
Jul 2023
First submitted
14 Jan 2020
Last updated
29 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vega-Abellaneda S, Roman E, Soler Z, Ortiz MA, Rossi G, Biagini L, Sanchez E, Pons-Tarin M, Laghi L, Mengucci C, Kaur N, Poca M, Cuyas B, Serrano-Gomez G, Alvarado E, Manichanh C, Soriano G. A Metagenomics Approach to Frailty in Patients With Cirrhosis Undergoing a Multifactorial Intervention. Liver Int. 2025 Dec;45(12):e70418. doi: 10.1111/liv.70418.

    PubMed 41174950

  • Roman E, Kaur N, Sanchez E, Poca M, Padros J, Nadal MJ, Cuyas B, Alvarado E, Vidal S, Ortiz MA, Hernandez E, Santesmases R, Urgell E, Juanes E, Ferrero-Gregori A, Escorsell A, Guarner C, Soriano G. Home exercise, branched-chain amino acids, and probiotics improve frailty in cirrhosis: A randomized clinical trial. Hepatol Commun. 2024 May 3;8(5):e0443. doi: 10.1097/HC9.0000000000000443. eCollection 2024 May 1.

    PubMed 38701490

Questions about this trial

What is this clinical trial studying?

A study testing Home exercise program for 12 months., Multispecies probiotic: Vivomixx® and Branched-chain amino acids (BCAA) in people with Cirrhosis of the Liver and Sarcopenia, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Substudy I: Mortality during hospitalization and follow-up (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04243148, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.

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