Nutrition DisordersPhase 1/2NCT02379624
Pectin Start Early Enteral Nutritional Support in Critically Ill Patients
A Phase 1/2 study testing pectin in people with Nutrition Disorders and Critical Illness, run by Xingwei Xu.
Trial summary
Acute lower gastrointestinal dysfunction is a kind of much common complication which occurred in critically ill patients. Once it developed, enteral nutrition would be disturbed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutrition Disorders, Critical Illness
- What is being tested?
- pectin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Jan 2015
- Phase
- Phase 1/2
- 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
- Adult ICU patients who were at least 18 years old if they were expected to require EN support within 36 hours after an unplanned ICU admission.
Who cannot join
- Could not be fed through enteral route,
- Had received EN in the past 2 months,
- Had a colectomy or jejunostomy in situ,
- Had severe colonic disease such as ulcerative colitis and Crohn's,
- Had pregnant,
- Had EN taboo crowd.
About this study
Acute lower gastrointestinal dysfunction is a kind of much common complication which occurred in critically ill patients. Once it developed, enteral nutrition would be disturbed. In this study, investigators suppose that early application of a sufficient amount of pectin ahead of enteral nutrition, may promote recovery of acute lower gastrointestinal dysfunction in critically ill patients, and exert its good effect on early EN support.
Investigators designed this prospective randomized controlled trial to test and evaluates the effect whether EN feeding with or without a pectin start would be safe or with advanced clinical outcomes.
Read the detailed description
Gastrointestinal function (GI) is an important determinant in the outcome of critically ill patients, with up to 62% of patients exhibiting at least one GI symptom for at least 1 day. Unlike the upper gastrointestinal dysfunction, which can be diagnosed early because of abdominal distension, nausea, and feeding intolerance, acute lower gastrointestinal dysfunction (ALGID) is a kind of more common complication which more easily neglected due to atypical symptoms. Once ALGID developed, critical patients could not get enteral nutrition (EN) normally, as early EN support is often essential and standard on critically ill patients when feasible. It also causes colonic bacteria reflux to the ileum and jejunum, leads to ischemic necrosis or colon perforation, and increases the incidence of various adverse events.
Dietary fiber (DF) plays an important and helpful role in GI. It undergoes partial or total fermentation in the distal small bowel and colon, leading to the production of short chain fatty acids (SCFA) and gas. It also helps to conduct slower and delayed gastroenterology absorption, and reduce luminal flow. To date, many research and evidences exist for DF-supplemented EN reduces the incidence of colonic dysfunction in non-intensive care unit studies. However, until recently, it still lacks guidelines on how to conduct DF-supplemented EN rationally in critically ill patients.
Pectin, a representative DF, is a gelatinous substance derived from the cell walls of fruits and some plants and contains galacturonan, consisting of mostly long-chain D-galacturonic acids combined into units by α-1,4 linkages. As a kind of soluble dietary fiber, pectin has been proved of controlling glucose and blood lipids. It slows rapid infusion of the liquid meal into the gut by delaying gastric emptying. Studies showed that 90% of ingested pectin can be found in the terminal ileum. In view of all the former studies data and on the basis of investigators' clinical observation, investigators postulate that early application of a sufficient amount of pectin ahead of EN, may promote ALGID recovery in critically ill patients, and exert its effect.
Investigators designed this prospective randomized controlled trial to test whether EN feeding with or without a pectin start would be safe or with advanced clinical outcomes. Investigators speculated that pectin start EN could nourish the digestive tract in critically ill patients, and it is superior to traditional EN feeding for the delivery of early nutritional support.
- Conditions
- Nutrition Disorders, Critical Illness
- Being tested
- pectin
- Medical subject headings
- Nutrition Disorders, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pectinDrug
Pectin, a representative diety fibre, is a gelatinous substance derived from the cell walls of fruits and some plants and contains galacturonan, consisting of mostly long-chain D-galacturonic acids combined into units by α-1,4 linkages. As a kind of soluble dietary fiber, pectin has been proved of controlling glucose and blood lipids. It slows rapid infusion of the liquid meal into the gut by delaying gastric emptying.
| Study group | Role | What they receive |
|---|---|---|
| EN group | Placebo comparator | 5% glucose at a rate of 25 mL/h was given at day 1, followed with initial amount of EN (31.25g peptisorb dissolved in 250ml water) at 12.5 mL/h on day 2. From day 3 to day 6, the prescription is EN (62.5g peptisorb dissolved in 250ml water) at 12.5 mL/h. Since day 7, EN was began to advance to goal energy target as quickly as possibl |
| PEC/EN group | Experimental | An additional amount of pectin was added 4 hours ahead of EN given from day 2 to day 6 (24g everday). Since day 7, EN was advanced to goal energy target as the same step Receives: Drug: pectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
Measured: 30 days
Secondary outcomes (9)
duration of organ support
Measured: 30 days
Efficacy as measured by frequency of treated infectious and noninfectious complications
Measured: 30 days
Efficacy as measured by frequency of Vomiting
Measured: 30 days
Efficacy as measured by frequency of Diarrhea
Measured: 30 days
Efficacy as measured by frequency of Abdominal distention or Cramping
Measured: 30 days
Efficacy as measured by frequency of Constipation
Measured: 30 days
Efficacy as measured by frequency of Regurgitation
Measured: 30 days
Efficacy as measured by frequency of Given antidiarrheal
Measured: 30 days
Efficacy as measured by frequency of Given prokinetic agents
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 posted5 Mar 2015 (estimated)
- Study startAug 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition DisordersStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xingwei Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xingwei Xu, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379624
- Sponsor's protocol ID
- NNSF81270884
- Status last verified
- Feb 2015
- First submitted
- 30 Aug 2014
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pectin Start Early Enteral Nutritional Support in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02379624
- Acronym / sponsor ID
- NNSF81270884
- Conditions
- Nutrition Disorders, Critical Illness
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Xingwei XuUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 5 Mar 2015 (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.
Acute lower gastrointestinal dysfunction is a kind of much common complication which occurred in critically ill patients. Once it developed, enteral nutrition would be disturbed. In this study, investigators suppose that early application of a sufficient amount of pectin ahead of enteral nutrition, may promote recovery of acute lower gastrointestinal dysfunction in critically ill patients, and exert its good effect on early EN support.
Investigators designed this prospective randomized controlled trial to test and evaluates the effect whether EN feeding with or without a pectin start would be safe or with advanced clinical outcomes.
Detailed description
Gastrointestinal function (GI) is an important determinant in the outcome of critically ill patients, with up to 62% of patients exhibiting at least one GI symptom for at least 1 day. Unlike the upper gastrointestinal dysfunction, which can be diagnosed early because of abdominal distension, nausea, and feeding intolerance, acute lower gastrointestinal dysfunction (ALGID) is a kind of more common complication which more easily neglected due to atypical symptoms. Once ALGID developed, critical patients could not get enteral nutrition (EN) normally, as early EN support is often essential and standard on critically ill patients when feasible. It also causes colonic bacteria reflux to the ileum and jejunum, leads to ischemic necrosis or colon perforation, and increases the incidence of various adverse events.
Dietary fiber (DF) plays an important and helpful role in GI. It undergoes partial or total fermentation in the distal small bowel and colon, leading to the production of short chain fatty acids (SCFA) and gas. It also helps to conduct slower and delayed gastroenterology absorption, and reduce luminal flow. To date, many research and evidences exist for DF-supplemented EN reduces the incidence of colonic dysfunction in non-intensive care unit studies. However, until recently, it still lacks guidelines on how to conduct DF-supplemented EN rationally in critically ill patients.
Pectin, a representative DF, is a gelatinous substance derived from the cell walls of fruits and some plants and contains galacturonan, consisting of mostly long-chain D-galacturonic acids combined into units by α-1,4 linkages. As a kind of soluble dietary fiber, pectin has been proved of controlling glucose and blood lipids. It slows rapid infusion of the liquid meal into the gut by delaying gastric emptying. Studies showed that 90% of ingested pectin can be found in the terminal ileum. In view of all the former studies data and on the basis of investigators' clinical observation, investigators postulate that early application of a sufficient amount of pectin ahead of EN, may promote ALGID recovery in critically ill patients, and exert its effect.
Investigators designed this prospective randomized controlled trial to test whether EN feeding with or without a pectin start would be safe or with advanced clinical outcomes. Investigators speculated that pectin start EN could nourish the digestive tract in critically ill patients, and it is superior to traditional EN feeding for the delivery of early nutritional support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EN group | Placebo comparator | –5% glucose at a rate of 25 mL/h was given at day 1, followed with initial amount of EN (31.25g peptisorb dissolved in 250ml water) at 12.5 mL/h on day 2. From day 3 to day 6, the prescription is EN (62.5g peptisorb dissolved in 250ml water) at 12.5 mL/h. Since day 7, EN was began to advance to goal energy target as quickly as possibl |
| PEC/EN group | Experimental | Drug: pectinAn additional amount of pectin was added 4 hours ahead of EN given from day 2 to day 6 (24g everday). Since day 7, EN was advanced to goal energy target as the same step |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult ICU patients who were at least 18 years old if they were expected to require EN support within 36 hours after an unplanned ICU admission.
Key exclusion criteria (6 listed)
- Could not be fed through enteral route,
- Had received EN in the past 2 months,
- Had a colectomy or jejunostomy in situ,
- Had severe colonic disease such as ulcerative colitis and Crohn's,
- Had pregnant,
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 |
|---|---|---|
| pectinPectin, a representative diety fibre, is a gelatinous substance derived from the cell walls of fruits and some plants and contains galacturonan, consisting of mostly long-chain D-galacturonic acids combined into units by α-1,4 linkages. As a kind of soluble dietary fiber, pectin has been proved of controlling glucose and blood lipids. It slows rapid infusion of the liquid meal into the gut by delaying gastric emptying. | Drug | PEC/EN group |
Primary outcome
all-cause mortality
Time frame: 30 days
9 secondary outcomes
duration of organ support
Time frame: 30 days
Efficacy as measured by frequency of treated infectious and noninfectious complications
Time frame: 30 days
Efficacy as measured by frequency of Vomiting
Time frame: 30 days
Efficacy as measured by frequency of Diarrhea
Time frame: 30 days
Efficacy as measured by frequency of Abdominal distention or Cramping
Time frame: 30 days
Efficacy as measured by frequency of Constipation
Time frame: 30 days
Efficacy as measured by frequency of Regurgitation
Time frame: 30 days
Efficacy as measured by frequency of Given antidiarrheal
Time frame: 30 days
Efficacy as measured by frequency of Given prokinetic agents
Time frame: 30 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 5 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing pectin in people with Nutrition Disorders and Critical Illness, run by Xingwei Xu.
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 1 inclusion and 6 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 5 Mar 2015. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
all-cause mortality (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 5 Mar 2015.