Critical IllnessPhase 2NCT01792401
Probiotics in Enteral Feeding in Critically Ill Patients
A Phase 2 study testing Probiotics in people with Critical Illness and Dietary Modification, run by University of Malaya at 1 site in Malaysia.
Trial summary
The purpose of this study is to investigate the effect of probiotics in enteral nutrition on improving gut function, inflammatory markers and clinical outcomes in critically ill patients admitted to the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Dietary Modification, Probiotics
- What is being tested?
- Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteMalaysia
- Study dates
- Jan 2012to Dec 2012
- Phase
- Phase 2
- 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
- Admitted to intensive care unit
- Expected stay of more than 48 hours
- On enteral feeding
- Consent obtained from patient/relative
Who cannot join
- Patients on immuno-suppressive drugs
- Patients with hematological diseases
- Pregnant females
- Do not consent
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University Malaya Medical Center
Kuala Lumpur, Kuala Lumpur, 59100
About this study
The purpose of this study is to investigate the effect of probiotics in enteral nutrition on improving gut function, inflammatory markers and clinical outcomes in critically ill patients admitted to the intensive care unit.
Read the detailed description
Gut failure in critically ill patients is common. Enteral feeding is one of the preferred routes for nutrition support to maintain gut function. However, enteral nutrition is not without complications such as alterations in gut transit time and gut eco-culture. Enteral nutrition supplemented with a probiotic offers a possible solution to modulating this ecosystem. Objectives: The primary aim of this study was to investigate the effect of probiotics in enteral feeding on improving the gut function, inflammatory markers and clinical outcomes in critically ill patients. Subjects and Methods: Forty-nine patients that were admitted to the intensive care unit in University Malaya Medical Center requiring enteral feeding were randomized to receive either probiotics or a placebo. Patients remained in the intensive care unit for more than 7 days and were examined prior to the start of enteral feeding and on day 8. Return of gut function was assessed by the time needed to achieve caloric requirement. Inflammatory markers including the White Cell Count and C-reactive protein levels were tested on day 1 and day 8. Clinical outcome was assessed by number of days of ventilation and total days in intensive care unit.
- Being tested
- Probiotics, Placebo
- Keywords
- Critical illness, Dietary supplements, Gastrointestinal tract/physio-pathology
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients on enteral feeding in intensive care units are administered a placebo Receives: Drug: Placebo |
| Probiotics | Active comparator | Patients on enteral feeding in intensive care unit are given a probiotic Receives: Drug: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve the time to return of gut function in patient on enteral feeding in intensive care unit
Probiotic/placebo administered once enteral feeding is started, and the hours needed to achieve maximum feeding is calculated in hours
Measured: Time required to achieve maximum enteral feeding with a minimum of 48 hours
Secondary outcomes (1)
Inflammatory markers
Measure of inflammatory markers are obtained from patients at the start and at the end of probiotic/placebo administrations.
Measured: 7-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionDec 2012
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 Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of MalayaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ausama A Malik, University of Malaya
- Investigators
- Ausama A Malik, MS,MBBS(Mal), Principal investigator, University Malaya Medical CenterKin Fah Chin, FRCS (Glasg), Study chair, University of MalayaVineya Rai Hakumat Rai, M. Anes,MBBS, Study chair, University of MalayaChee Loong Yeap, MS,MBBS(Mal), Study chair, University of MalayaPeng Choong Lau, MS,MBBS(Mal), Study chair, University of MalayaEng Hong Pok, MS,MBBS(Mal), Study chair, University of MalayaGowri Rajandram, Phd(Aust), Study chair, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792401
- Sponsor's protocol ID
- PEFCIP
- Status last verified
- Feb 2013
- First submitted
- 8 Feb 2013
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Malik AA, Rajandram R, Tah PC, Hakumat-Rai VR, Chin KF. Microbial cell preparation in enteral feeding in critically ill patients: A randomized, double-blind, placebo-controlled clinical trial. J Crit Care. 2016 Apr;32:182-8. doi: 10.1016/j.jcrc.2015.12.008. Epub 2015 Dec 15.
PubMed 26777745
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics in Enteral Feeding in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01792401
- Acronym / sponsor ID
- PEFCIP
- Keywords
- Critical illness, Dietary supplements, Gastrointestinal tract/physio-pathology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Feb 2013 (estimated)
- 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.
The purpose of this study is to investigate the effect of probiotics in enteral nutrition on improving gut function, inflammatory markers and clinical outcomes in critically ill patients admitted to the intensive care unit.
Detailed description
Gut failure in critically ill patients is common. Enteral feeding is one of the preferred routes for nutrition support to maintain gut function. However, enteral nutrition is not without complications such as alterations in gut transit time and gut eco-culture. Enteral nutrition supplemented with a probiotic offers a possible solution to modulating this ecosystem. Objectives: The primary aim of this study was to investigate the effect of probiotics in enteral feeding on improving the gut function, inflammatory markers and clinical outcomes in critically ill patients. Subjects and Methods: Forty-nine patients that were admitted to the intensive care unit in University Malaya Medical Center requiring enteral feeding were randomized to receive either probiotics or a placebo. Patients remained in the intensive care unit for more than 7 days and were examined prior to the start of enteral feeding and on day 8. Return of gut function was assessed by the time needed to achieve caloric requirement. Inflammatory markers including the White Cell Count and C-reactive protein levels were tested on day 1 and day 8. Clinical outcome was assessed by number of days of ventilation and total days in intensive care unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPatients on enteral feeding in intensive care units are administered a placebo |
| Probiotics | Active comparator | Drug: ProbioticsPatients on enteral feeding in intensive care unit are given a probiotic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admitted to intensive care unit
- Expected stay of more than 48 hours
- On enteral feeding
- Consent obtained from patient/relative
Key exclusion criteria (4 listed)
- Patients on immuno-suppressive drugs
- Patients with hematological diseases
- Pregnant females
- Do not consent
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 |
|---|---|---|
| Probiotics | Drug | Probiotics |
| Placebo | Drug | Placebo |
Primary outcome
Improve the time to return of gut function in patient on enteral feeding in intensive care unit
Time frame: Time required to achieve maximum enteral feeding with a minimum of 48 hours
Probiotic/placebo administered once enteral feeding is started, and the hours needed to achieve maximum feeding is calculated in hours
1 secondary outcome
Inflammatory markers
Time frame: 7-14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
- Derived from this study: PubMed 26777745Malik AA, Rajandram R, Tah PC, Hakumat-Rai VR, Chin KF. Microbial cell preparation in enteral feeding in critically ill patients: A randomized, double-blind, placebo-controlled clinical trial. J Crit Care. 2016 Apr;32:182-8. doi: 10.1016/j.jcrc.2015.12.008. Epub 2015 Dec 15.
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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.
Ausama A Malik, MS,MBBS(Mal) principal investigator
University Malaya Medical Center
Kin Fah Chin, FRCS (Glasg) study chair
University of Malaya
Vineya Rai Hakumat Rai, M. Anes,MBBS study chair
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotics in people with Critical Illness and Dietary Modification, run by University of Malaya at 1 site in Malaysia.
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 4 inclusion and 4 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 15 Feb 2013. 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 Malaysia. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improve the time to return of gut function in patient on enteral feeding in intensive care unit (time frame: Time required to achieve maximum enteral feeding with a minimum of 48 hours). 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 NCT01792401, 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 15 Feb 2013.