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CompletedNCT02379624Updated Mar 5, 2015

Pectin Start Early Enteral Nutritional Support in Critically Ill Patients

A Phase 1/2 interventional study of pectin in Nutrition Disorders and Critical Illness, sponsored by Xingwei Xu. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-05.

Sponsored by Xingwei Xu · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
125
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Nutrition Disorders
  • Critical Illness
03

In context

Nutrition Disorders

275 studies on the registry are indexed under Nutrition Disorders; 31 are open to participants now.

This study's enrollment of 125 is close to the median of 117 across 194 interventional studies indexed under Nutrition Disorders.

Browse Nutrition Disorders studies →

Lead sponsor

This is the only study on the registry with Xingwei Xu as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria::

  • 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.

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
125 participants (actual)

Study arms

  • Placebo comparator
    EN group

    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

  • Experimental
    PEC/EN group

    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

    Drug: pectin

Interventions

  • Drugpectin

    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.

06

What researchers measure

Primary outcomes

  1. all-cause mortality

    Time frame: 30 days

Secondary outcomes

  1. duration of organ support

    Time frame: 30 days

  2. Efficacy as measured by frequency of treated infectious and noninfectious complications

    Time frame: 30 days

  3. Efficacy as measured by frequency of Vomiting

    Time frame: 30 days

  4. Efficacy as measured by frequency of Diarrhea

    Time frame: 30 days

  5. Efficacy as measured by frequency of Abdominal distention or Cramping

    Time frame: 30 days

  6. Efficacy as measured by frequency of Constipation

    Time frame: 30 days

  7. Efficacy as measured by frequency of Regurgitation

    Time frame: 30 days

  8. Efficacy as measured by frequency of Given antidiarrheal

    Time frame: 30 days

  9. Efficacy as measured by frequency of Given prokinetic agents

    Time frame: 30 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02379624
Lead sponsor
Xingwei Xu
Responsible party
Xingwei Xu (Doctor, Nanjing University) — Sponsor-investigator
First posted
Mar 5, 2015
Start date
Aug 2014
Primary completion
Jan 2015
Completion
Jan 2015
Last update
Mar 5, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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