DiarrhoeaPrebioticFOSNCT02144168
The Effect of Enteral Nutrition Supplemented With Prebiotics on Colonic Microbiota in the Critically Ill Patients
A study testing Prebiotics-free enteral formula and Prebiotics containing enteral formula in people with Diarrhoea, run by University of Malaya at 1 site in Malaysia.
Trial summary
Primary objective of this study is to measure the change of concentration of faecal bifidobacteria between critically ill patients who receive enteral formula with and without prebiotics during enteral nutrition.Our null hypothesis is that there is no difference in the concentration of faecal bifidobacteria between… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diarrhoea
- What is being tested?
- Prebiotics-free enteral formula and Prebiotics containing enteral formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMalaysia
- Study dates
- Jan 2014to Sep 2014
- 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
- Patients receiving exclusive EN , nasogastric, continuous infusion
- Adult patients , 18 years old and above
- Critically ill patients
- Expected to require EN more than five days(Bleichner et al., 1997)
Who cannot join
- Patients with gastrointestinal disease (Sokol et al., 2006) or GIT surgery
- Patients receiving lactulose (Bouhnik et al., 2004)
- Currently under chemotherapy treatment (Kapkac et al., 2003)
- Patients who had received prebiotics and probiotics supplements within the previous one month
- Patients who have diarrhoea, 3 consecutive days (Majid et al, 2013)
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University Malaya Medical Centre
Petaling Jaya, Kuala Lumpur, 50603
About this study
Official title: The Effect of Enteral Nutrition Supplemented With Prebiotics on Colonic Microbiota in the Critically Ill Patients: A Randomized Controlled Trial
Primary objective of this study is to measure the change of concentration of faecal bifidobacteria between critically ill patients who receive enteral formula with and without prebiotics during enteral nutrition.Our null hypothesis is that there is no difference in the concentration of faecal bifidobacteria between critically ill patients who receive enteral formula with and without prebiotics during enteral nutrition (EN). Three faecal samples will be taken from the patient. First faecal sample is the first stool after initiation of EN and second sample is taken seven days after the initial sample and the third faecal sample is taken at day 14 after initial sample. Patient will be randomized to receive either of described formula after baseline (first) stool sample is obtained. Patient will be monitored up to 14 days after the initial stool sample is obtained.
Read the detailed description
Written approval of the study has been obtained from the University Malaya Medical Centre (UMMC) Ethics Committee before commencement of this study
Patients will be screened for inclusion and exclusion criteria of the study and consent will be obtained from the patients or their legal representative in view of most critically ill patients are unconscious. Patients or their legal representative will be briefed regarding the objectives and the design of the study.
Critically ill patients recruited for this study will be exclusively on EN as clinically indicated. The volume of formula prescribed is based on each patient's total energy expenditure, which will be calculated by clinical dietitians. Formula will be delivered through a Ryles tube according to dietitians' order.
A faecal sample from the recruited patients will be collected for analysis at baseline, the first stool output after initiation of EN. Once baseline sample is collected, patients will be randomly assigned to receive enteral formula with or without prebiotics. Randomisation will be generated by using the website Randomization.com (http://www.randomization.com). Patients will be monitored for at least 14 days from passage of the first faecal sample after initiation of EN.
A faecal sample will be collected for analysis on days 0, 7, and 14. If there is absence of habitual or meal cues to stool output, samples will be collected and analyzed from each patient during 3 days periods at Day 6-8 for second faecal sample and Day 12-14 for the third faecal sample.
To guarantee accurate measurement of microbiota and shirt chain fatty acids (SCFA), only fresh faecal samples will be analyzed.Faecal samples will be collected within 1 hour of voiding and will immediately be transported to the laboratory for analysis of microbiota. The faecal sample will be homogenized using a sterile stainless steel Waring blender and aliquots of each specimen and will be frozen at -80°C until DNA is extracted.
Although the study is an open-label study, the researcher will be blinded for the analysis of the faecal sample for the quantification of faecal microbiota and short SCFA. An external Predominant component of the faecal microbiota; Bacteroides, Bifidobacteria, Clostridia and Lactobacilli will be quantified using Real Time Polymerase Chain Reaction (PCR). Faecal SCFA will be analyzed using gas-liquid chromatography, and C.difficile-enterotoxins A and B will be measured using enzyme-linked immunosorbent assay kit.
Faecal output will be recorded by nursing staff using a stool chart validated for use in this patient group. The chart will aid in the characterization of faecal frequency, consistency, and weight, which are then summarized into a daily stool score. A score of 15 or more is used to indicate diarrhoea (Whelan, Judd, Preedy, \& Taylor, 2008). Patients will be visited once, daily during weekdays and contacted by telephone during weekends to monitor data recording by the nursing staff.
Details of EN regimen; formula used, amount, frequency, route and mode of delivery will be recorded progressively. Demographic data such as age sex, race and clinical details such as antibiotic, medications prescription and patients' progression will be extracted from the patients' medical notes daily.
- Conditions
- Diarrhoea
- Being tested
- Prebiotics-free enteral formula, Prebiotics containing enteral formula
- Keywords
- Prebiotics, diarrhoea, Enteral nutrition, Fibre, Bifidobacteria, SCFA
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotics-free enteral formulaDietary supplement
Also called Osmolite 1 cal
Patient will be given Osmolite 1 cal for 2 weeks after baseline stool sample obtained
Prebiotics containing enteral formulaDietary supplement
Also called Ensure Fos
Patient will be given Ensure Fos for 2 weeks after baseline stool sample obtained
| Study group | Role | What they receive |
|---|---|---|
| prebiotics-free enteral formula | Active comparator | Patients in this arm will be receiving standard, prebiotics-free enteral formula : Osmolite 1 cal Receives: Dietary Supplement: Prebiotics-free enteral formula |
| prebiotics containing enteral formula | Experimental | Patients in this arm will be receiving prebiotics containing enteral formula:Ensure Fos for 14 days Receives: Dietary Supplement: Prebiotics containing enteral formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of diarrhoea
Measured: up to 14 days post intervention
Secondary outcomes (1)
Changes in faecal microbiota
Measured: baseline, 1 week & 2 weeks after baseline sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DiarrhoeaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mazuin Kamarul Zaman, University of Malaya
- Investigators
- Mazuin Kamarul Zaman, BSc (RD), Principal investigator, University of MalayaHazreen Abdul Majid, BSc(RD),PhD, Principal investigator, University of MalayaVineya Rai Hakumat Rai, MBBS, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144168
- Sponsor's protocol ID
- PG127-2013A
- Acronym
- PrebioticFOS
- Status last verified
- May 2014
- First submitted
- 19 May 2014
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Bleichner G, Blehaut H, Mentec H, Moyse D. Saccharomyces boulardii prevents diarrhea in critically ill tube-fed patients. A multicenter, randomized, double-blind placebo-controlled trial. Intensive Care Med. 1997 May;23(5):517-23. doi: 10.1007/s001340050367.
PubMed 9201523Sokol H, Seksik P, Rigottier-Gois L, Lay C, Lepage P, Podglajen I, Marteau P, Dore J. Specificities of the fecal microbiota in inflammatory bowel disease. Inflamm Bowel Dis. 2006 Feb;12(2):106-11. doi: 10.1097/01.MIB.0000200323.38139.c6.
PubMed 16432374Bouhnik Y, Attar A, Joly FA, Riottot M, Dyard F, Flourie B. Lactulose ingestion increases faecal bifidobacterial counts: a randomised double-blind study in healthy humans. Eur J Clin Nutr. 2004 Mar;58(3):462-6. doi: 10.1038/sj.ejcn.1601829.
PubMed 14985684Kapkac, M., Erikoglu, M., Tuncyurek, P., Ersin, S., Esassolak, M., Alkanat, M., & Sipahioglu, O. (2003). Fiber enriched diets and radiation induced injury of the gut. Nutrition research (New York, N.Y.), 23(1), 77-83
Whelan K, Judd PA, Preedy VR, Taylor MA. Covert assessment of concurrent and construct validity of a chart to characterize fecal output and diarrhea in patients receiving enteral nutrition. JPEN J Parenter Enteral Nutr. 2008 Mar-Apr;32(2):160-8. doi: 10.1177/0148607108314769.
PubMed 18407909Majid HA, Cole J, Emery PW, Whelan K. Additional oligofructose/inulin does not increase faecal bifidobacteria in critically ill patients receiving enteral nutrition: a randomised controlled trial. Clin Nutr. 2014 Dec;33(6):966-72. doi: 10.1016/j.clnu.2013.11.008. Epub 2013 Nov 16.
PubMed 24290345
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Enteral Nutrition Supplemented With Prebiotics on Colonic Microbiota in the Critically Ill Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02144168
- Acronym / sponsor ID
- PrebioticFOS / PG127-2013A
- Conditions
- Diarrhoea
- Keywords
- Prebiotics, diarrhoea, Enteral nutrition, Fibre, Bifidobacteria, SCFA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 21 May 2014 (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.
Primary objective of this study is to measure the change of concentration of faecal bifidobacteria between critically ill patients who receive enteral formula with and without prebiotics during enteral nutrition.Our null hypothesis is that there is no difference in the concentration of faecal bifidobacteria between critically ill patients who receive enteral formula with and without prebiotics during enteral nutrition (EN). Three faecal samples will be taken from the patient. First faecal sample is the first stool after initiation of EN and second sample is taken seven days after the initial sample and the third faecal sample is taken at day 14 after initial sample. Patient will be randomized to receive either of described formula after baseline (first) stool sample is obtained. Patient will be monitored up to 14 days after the initial stool sample is obtained.
Detailed description
Written approval of the study has been obtained from the University Malaya Medical Centre (UMMC) Ethics Committee before commencement of this study
Patients will be screened for inclusion and exclusion criteria of the study and consent will be obtained from the patients or their legal representative in view of most critically ill patients are unconscious. Patients or their legal representative will be briefed regarding the objectives and the design of the study.
Critically ill patients recruited for this study will be exclusively on EN as clinically indicated. The volume of formula prescribed is based on each patient's total energy expenditure, which will be calculated by clinical dietitians. Formula will be delivered through a Ryles tube according to dietitians' order.
A faecal sample from the recruited patients will be collected for analysis at baseline, the first stool output after initiation of EN. Once baseline sample is collected, patients will be randomly assigned to receive enteral formula with or without prebiotics. Randomisation will be generated by using the website Randomization.com (http://www.randomization.com). Patients will be monitored for at least 14 days from passage of the first faecal sample after initiation of EN.
A faecal sample will be collected for analysis on days 0, 7, and 14. If there is absence of habitual or meal cues to stool output, samples will be collected and analyzed from each patient during 3 days periods at Day 6-8 for second faecal sample and Day 12-14 for the third faecal sample.
To guarantee accurate measurement of microbiota and shirt chain fatty acids (SCFA), only fresh faecal samples will be analyzed.Faecal samples will be collected within 1 hour of voiding and will immediately be transported to the laboratory for analysis of microbiota. The faecal sample will be homogenized using a sterile stainless steel Waring blender and aliquots of each specimen and will be frozen at -80°C until DNA is extracted.
Although the study is an open-label study, the researcher will be blinded for the analysis of the faecal sample for the quantification of faecal microbiota and short SCFA. An external Predominant component of the faecal microbiota; Bacteroides, Bifidobacteria, Clostridia and Lactobacilli will be quantified using Real Time Polymerase Chain Reaction (PCR). Faecal SCFA will be analyzed using gas-liquid chromatography, and C.difficile-enterotoxins A and B will be measured using enzyme-linked immunosorbent assay kit.
Faecal output will be recorded by nursing staff using a stool chart validated for use in this patient group. The chart will aid in the characterization of faecal frequency, consistency, and weight, which are then summarized into a daily stool score. A score of 15 or more is used to indicate diarrhoea (Whelan, Judd, Preedy, \& Taylor, 2008). Patients will be visited once, daily during weekdays and contacted by telephone during weekends to monitor data recording by the nursing staff.
Details of EN regimen; formula used, amount, frequency, route and mode of delivery will be recorded progressively. Demographic data such as age sex, race and clinical details such as antibiotic, medications prescription and patients' progression will be extracted from the patients' medical notes daily.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prebiotics-free enteral formula | Active comparator | Dietary Supplement: Prebiotics-free enteral formulaPatients in this arm will be receiving standard, prebiotics-free enteral formula : Osmolite 1 cal |
| prebiotics containing enteral formula | Experimental | Dietary Supplement: Prebiotics containing enteral formulaPatients in this arm will be receiving prebiotics containing enteral formula:Ensure Fos for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients receiving exclusive EN , nasogastric, continuous infusion
- Adult patients , 18 years old and above
- Critically ill patients
- Expected to require EN more than five days(Bleichner et al., 1997)
Key exclusion criteria (5 listed)
- Patients with gastrointestinal disease (Sokol et al., 2006) or GIT surgery
- Patients receiving lactulose (Bouhnik et al., 2004)
- Currently under chemotherapy treatment (Kapkac et al., 2003)
- Patients who had received prebiotics and probiotics supplements within the previous one month
- Patients who have diarrhoea, 3 consecutive days (Majid et al, 2013)
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 |
|---|---|---|
| Prebiotics-free enteral formulaAlso: Osmolite 1 calPatient will be given Osmolite 1 cal for 2 weeks after baseline stool sample obtained | Dietary supplement | prebiotics-free enteral formula |
| Prebiotics containing enteral formulaAlso: Ensure FosPatient will be given Ensure Fos for 2 weeks after baseline stool sample obtained | Dietary supplement | prebiotics containing enteral formula |
Primary outcome
Incidence of diarrhoea
Time frame: up to 14 days post intervention
1 secondary outcome
Changes in faecal microbiota
Time frame: baseline, 1 week & 2 weeks after baseline sample
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2014.
- Background: PubMed 9201523Bleichner G, Blehaut H, Mentec H, Moyse D. Saccharomyces boulardii prevents diarrhea in critically ill tube-fed patients. A multicenter, randomized, double-blind placebo-controlled trial. Intensive Care Med. 1997 May;23(5):517-23. doi: 10.1007/s001340050367.
- Background: PubMed 16432374Sokol H, Seksik P, Rigottier-Gois L, Lay C, Lepage P, Podglajen I, Marteau P, Dore J. Specificities of the fecal microbiota in inflammatory bowel disease. Inflamm Bowel Dis. 2006 Feb;12(2):106-11. doi: 10.1097/01.MIB.0000200323.38139.c6.
- Background: PubMed 14985684Bouhnik Y, Attar A, Joly FA, Riottot M, Dyard F, Flourie B. Lactulose ingestion increases faecal bifidobacterial counts: a randomised double-blind study in healthy humans. Eur J Clin Nutr. 2004 Mar;58(3):462-6. doi: 10.1038/sj.ejcn.1601829.
- BackgroundKapkac, M., Erikoglu, M., Tuncyurek, P., Ersin, S., Esassolak, M., Alkanat, M., & Sipahioglu, O. (2003). Fiber enriched diets and radiation induced injury of the gut. Nutrition research (New York, N.Y.), 23(1), 77-83
- Background: PubMed 18407909Whelan K, Judd PA, Preedy VR, Taylor MA. Covert assessment of concurrent and construct validity of a chart to characterize fecal output and diarrhea in patients receiving enteral nutrition. JPEN J Parenter Enteral Nutr. 2008 Mar-Apr;32(2):160-8. doi: 10.1177/0148607108314769.
- Background: PubMed 24290345Majid HA, Cole J, Emery PW, Whelan K. Additional oligofructose/inulin does not increase faecal bifidobacteria in critically ill patients receiving enteral nutrition: a randomised controlled trial. Clin Nutr. 2014 Dec;33(6):966-72. doi: 10.1016/j.clnu.2013.11.008. Epub 2013 Nov 16.
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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.
Mazuin Kamarul Zaman, BSc (RD) principal investigator
University of Malaya
Hazreen Abdul Majid, BSc(RD),PhD principal investigator
University of Malaya
Vineya Rai Hakumat Rai, MBBS principal investigator
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 study testing Prebiotics-free enteral formula and Prebiotics containing enteral formula in people with Diarrhoea, 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 5 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 21 May 2014. 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. 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 Mazuin Kamarul Zaman (+60379677896, mazukmz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of diarrhoea (time frame: up to 14 days post intervention). 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 NCT02144168, which also lists 6 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 21 May 2014.