InfectionsPhase 4NCT05543226
The Effect of PHGG-rich Enteral Nutrition to on the Infection in Liver Transplant Recipients: A Prospective, Double-blind, Randomized Controlled Study
A Phase 4 study testing PHGG-rich enteral nutrtiion in people with Infections, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
To known the effect of PHGG-rich enteral nutrition to on the infection in liver transplant recipients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Infections
- What is being tested?
- PHGG-rich enteral nutrtiion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 30 Sep 2024
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- liver transplant recipients
- age from 18 to 80 years old
- APACHE II score >12
- There is an indication for enteral nutrition and it is expected to require oral or tube feeding for more than 7 days
- there is no intra-abdominal infection or bloodstream infection
Who cannot join
- Severe cardiac, kidney and lung dysfunction
- bowel obstruction, intestinal perforation, intestinal leakage before operation
- Roux and Y anastomosis during liver transplant
Trial locations and contacts
No sites are listed yet.
About this study
To known the effect of PHGG-rich enteral nutrition to on the infection in liver transplant recipients
- Conditions
- Infections
- Being tested
- PHGG-rich enteral nutrtiion
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHGG-rich enteral nutrtiionDrug
PHGG-rich enteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| PHGG | Experimental | Not described Receives: Drug: PHGG-rich enteral nutrtiion |
| without PHGG | Placebo comparator | Not described Receives: Drug: PHGG-rich enteral nutrtiion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of infections after liver transplantation
the incidence of infections after 30 days of the liver transplantation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543226
- Sponsor's protocol ID
- 2022-KY-029
- Status last verified
- Mar 2022
- First submitted
- 14 Sep 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of PHGG-rich Enteral Nutrition to on the Infection in Liver Transplant Recipients: A Prospective, Double-blind, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05543226
- Acronym / sponsor ID
- 2022-KY-029
- Conditions
- Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 16 Sep 2022 (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.
To known the effect of PHGG-rich enteral nutrition to on the infection in liver transplant recipients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHGG | Experimental | Drug: PHGG-rich enteral nutrtiion |
| without PHGG | Placebo comparator | Drug: PHGG-rich enteral nutrtiion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- liver transplant recipients
- age from 18 to 80 years old
- APACHE II score >12
- There is an indication for enteral nutrition and it is expected to require oral or tube feeding for more than 7 days
- there is no intra-abdominal infection or bloodstream infection
Key exclusion criteria (3 listed)
- Severe cardiac, kidney and lung dysfunction
- bowel obstruction, intestinal perforation, intestinal leakage before operation
- Roux and Y anastomosis during liver transplant
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 |
|---|---|---|
| PHGG-rich enteral nutrtiionPHGG-rich enteral nutrition | Drug | PHGG, without PHGG |
Primary outcome
Incidence of infections after liver transplantation
Time frame: 30 days
the incidence of infections after 30 days of the liver transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Infections
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PHGG-rich enteral nutrtiion in people with Infections, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 5 inclusion and 3 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 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Qing He (+8613710329468, heqing@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of infections after liver transplantation (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2022.