MalnutritionNCT06128421
Individual Nutrition Support in HBV-ACLF Patients at Nutrition Risk
A study testing Individual nutritional support in people with Malnutrition and Hepatitis B,Chronic, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This study aims to investigate the safety and efficacy of individual nutrition support for treating hepatitis b virus(HBV) related acute-on-chronic liver failure patients at nutrition risk Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Malnutrition, Hepatitis B,Chronic, Acute-On-Chronic Liver Failure
- What is being tested?
- Individual nutritional support
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2023to 31 Oct 2024
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 20 to 60 years old;
- Clinical diagnosis of chronic hepatitis b virus infection(positive hepatitis b surface antigen or positive hepatitis b virus DNA >0.5 year
- serum total bilirubin level ≥12 mg/dl
- prothrombin time international ratio ≥1.5
- NRS≥ 3points
- COSSH-ACLF IIs <8.4 points
Who cannot join
- Other active liver disease;
- Hepatocellular carcinoma or other malignancy, HIV, Chronic kidney disease(CKD), diabetes, thyroid disease, cardiopulmonary disease, neuromuscular diseases, serious psychiatric disease;
- Acute cholecystitis, acute pancreatitis, biliary obstruction, short bowel syndrome, intestinal obstruction, inflammatory bowel disease;
- Severe complications or other organ failure including sever infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal failure(AGI III-IV);
- Pregnancy, BMI<18.5 or BMI ≥28，organ transplantation, bed-ridden;
- Unable to ingest oral nutrition, contraindication against parenteral nutrition
- Admitted with enteral or parenteral nutrition in the last week
- expected hospital length of stay<3 days，.expected residence in Guangdong Province length of live< 90 days
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Liang Peng, Doctor, +8613533978874, pzp33@hotmail.com
About this study
Official title: Individual Nutrition Support in HBV-ACLF Patients at Nutrition Risk: a Randomized Controlled Trail
This study aims to investigate the safety and efficacy of individual nutrition support for treating hepatitis b virus(HBV) related acute-on-chronic liver failure patients at nutrition risk
Read the detailed description
The aims of the randomized-controlled trial are to test the hypothesis that in medical inpatients with HBV related ACLF at risk for undernutrition defined by the nutritional risk score (NRS 2002), tailored nutritional therapy to reach nutritional targets based on individualized nutritional counseling is a effective strategy to prevent mortality, morbidity and functional decline.
Sixty patients with HBV related ACLF will be enrolled in this study. The participants are divided into trial Patients in the trail group will receive individualized nutritional therapy to reach nutritional targets (caloric, protein, others) based on a predefined nutritional strategy.In control patients, according to patients' appetite, standard hospital nutrition will be served. Nutritional therapy may be started in control patients, if any sort of swallowing disorders develops or if patients need to be prepared for operation. All patients will be re-assessed daily during the hospital stay for nutritional intake and nutritional therapy may be escalated within first 3days ( oral supplements, parenteral nutrition) if targets are not met (at least 75% of targets).
- Being tested
- Individual nutritional support
- Medical subject headings
- Malnutrition, Hepatitis B, Chronic, Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual nutritional supportDietary supplement
Nutritional products and route（oral, parenteral）is possible to reach goals
| Study group | Role | What they receive |
|---|---|---|
| Trail Group | Experimental | 30 patients will receive dietary counseling and individual nutrition support treatment based on Oral nutrition supplements and supplemented by parenteral nutrition. Receives: Dietary Supplement: Individual nutritional support |
| Control Group | No intervention | 30 patients will receive standard care food provided by the hospital kitchen according to their ability and desire, standard care food provided by the hospital kitchen. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant free survival at 30 days
Measured: 30 days
Transplant free survival at 90 days
Measured: 90 days
Secondary outcomes (8)
L3-SMI as a marker of muscle mass
Third lumbar skeletal muscle index(L3-SMI) by CT scan
Measured: 30 days, 90days
Grip as markers of muscle strength
Grip
Measured: 30 days, 90days
Short Physical Performance Battery (SPPB) as markers of physical performance
The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests.
Measured: 30 days, 90 days
Improvement in quality of life
Improvement in quality of life measured with the EuroQol Group 5-Dimension Self-Report Questionnaire on admission and during follow up measured by patient interview
Measured: 30 days, 90days
length of hospital stay
days in the hospital within index hospitalisation and within the 90 days of follow up measured by patient interview and medical chart review
Measured: days in the hospital within index hospitalisation and within the 30 days of follow up measured by patient interview and medical chart review
Energy intake
Protein-calorie intake as assessed by serial 24-hour dietary recall
Measured: 10 days
hepatic adverse outcomes
hepatic encephalopathy，esophageal variceal hemorrhage，etc
Measured: 10days,30 days, 90 days
Combined safety endpoints in regard to side effects from nutritional therapy
Number of participants with side effects from nutritional support including
(a) adverse gastrointestinal effects (diarrhea, nausea, vomiting, abdominal pain, abdominal distention) assessed by patient interview (yes/no) b) Complications due to center catheter for parenteral nutrition assessed by medical chart review (c) Refeeding syndrome assessed by chart review (d) Acute pancreatitis defined as 2 out of 3 criteria: abdominal pain, 3-fold increase in lipase or amylase, characteristic imaging findings assessed by chart review (e) Liver or gall bladder dysfunction assessed by chart review (f) Hyperglycemia (defined as glucose levels persistent levels >10mmol/l in patients without diabetes or well controlled diabetes) assessed by medical chart review
Measured: measured at day 10 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start23 Nov 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128421
- Sponsor's protocol ID
- PL17
- Status last verified
- Jan 2024
- First submitted
- 6 Nov 2023
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Z, Luo Q, Wang P, Wang L, Zheng X, Zhang Y, Xu W, Peng L. Efficacy and safety of individual nutrition support in patients with hepatitis B virus-related acute-on-chronic liver failure at nutrition risk: a study protocol for a randomised controlled clinical trial. BMJ Open. 2024 Dec 9;14(12):e088832. doi: 10.1136/bmjopen-2024-088832.
PubMed 39653573
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Nutrition Support in HBV-ACLF Patients at Nutrition Risk: a Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT06128421
- Acronym / sponsor ID
- PL17
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the safety and efficacy of individual nutrition support for treating hepatitis b virus(HBV) related acute-on-chronic liver failure patients at nutrition risk
Detailed description
The aims of the randomized-controlled trial are to test the hypothesis that in medical inpatients with HBV related ACLF at risk for undernutrition defined by the nutritional risk score (NRS 2002), tailored nutritional therapy to reach nutritional targets based on individualized nutritional counseling is a effective strategy to prevent mortality, morbidity and functional decline.
Sixty patients with HBV related ACLF will be enrolled in this study. The participants are divided into trial Patients in the trail group will receive individualized nutritional therapy to reach nutritional targets (caloric, protein, others) based on a predefined nutritional strategy.In control patients, according to patients' appetite, standard hospital nutrition will be served. Nutritional therapy may be started in control patients, if any sort of swallowing disorders develops or if patients need to be prepared for operation. All patients will be re-assessed daily during the hospital stay for nutritional intake and nutritional therapy may be escalated within first 3days ( oral supplements, parenteral nutrition) if targets are not met (at least 75% of targets).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trail Group | Experimental | Dietary Supplement: Individual nutritional support30 patients will receive dietary counseling and individual nutrition support treatment based on Oral nutrition supplements and supplemented by parenteral nutrition. |
| Control Group | No intervention | –30 patients will receive standard care food provided by the hospital kitchen according to their ability and desire, standard care food provided by the hospital kitchen. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age from 20 to 60 years old;
- Clinical diagnosis of chronic hepatitis b virus infection(positive hepatitis b surface antigen or positive hepatitis b virus DNA >0.5 year
- serum total bilirubin level ≥12 mg/dl
- prothrombin time international ratio ≥1.5
- NRS≥ 3points
Key exclusion criteria (8 listed)
- Other active liver disease;
- Hepatocellular carcinoma or other malignancy, HIV, Chronic kidney disease(CKD), diabetes, thyroid disease, cardiopulmonary disease, neuromuscular diseases, serious psychiatric disease;
- Acute cholecystitis, acute pancreatitis, biliary obstruction, short bowel syndrome, intestinal obstruction, inflammatory bowel disease;
- Severe complications or other organ failure including sever infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal failure(AGI III-IV);
- Pregnancy, BMI<18.5 or BMI ≥28，organ transplantation, bed-ridden;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual nutritional supportNutritional products and route（oral, parenteral）is possible to reach goals | Dietary supplement | Trail Group |
Primary outcome
Transplant free survival at 30 days
Time frame: 30 days
Transplant free survival at 90 days
Time frame: 90 days
8 secondary outcomes
L3-SMI as a marker of muscle mass
Time frame: 30 days, 90days
Grip as markers of muscle strength
Time frame: 30 days, 90days
Short Physical Performance Battery (SPPB) as markers of physical performance
Time frame: 30 days, 90 days
Improvement in quality of life
Time frame: 30 days, 90days
length of hospital stay
Time frame: days in the hospital within index hospitalisation and within the 30 days of follow up measured by patient interview and medical chart review
Energy intake
Time frame: 10 days
hepatic adverse outcomes
Time frame: 10days,30 days, 90 days
Combined safety endpoints in regard to side effects from nutritional therapy
Time frame: measured at day 10 and 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Derived from this study: PubMed 39653573Li Z, Luo Q, Wang P, Wang L, Zheng X, Zhang Y, Xu W, Peng L. Efficacy and safety of individual nutrition support in patients with hepatitis B virus-related acute-on-chronic liver failure at nutrition risk: a study protocol for a randomised controlled clinical trial. BMJ Open. 2024 Dec 9;14(12):e088832. doi: 10.1136/bmjopen-2024-088832.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual nutritional support in people with Malnutrition and Hepatitis B,Chronic, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Jan 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Zhipeng (+8613725480127, lzp1219@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplant free survival at 30 days (time frame: 30 days). 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 NCT06128421, which also lists 1 linked publication.
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 25 Jan 2024.