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Status unknownNCT04021979Updated Jul 16, 2019

Effectiveness of Enteral Nutrition for Dose Reduction of Low Dose PEG

An interventional study of Enteral Nutrition Powder Ensure and 1.5L PEG in Bowel Preparation, sponsored by Ningbo No. 1 Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-16.

Sponsored by Ningbo No. 1 Hospital · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
248
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This clinical trial is being conducted to assess whether dietary restriction with enteral nutrition prescribed could prevent nonadherence to dietary restrictions, enable additional reduction of the required volume of PEG-ELS.

Read the detailed description

Bowel preparation plays a vital role in the quality of colonoscopy.Bowel preparation consists of 2 key steps: dietary restriction and purgative ingestion.Two liters of PEG-ELS are widely used in Asian countries, but in a well-designed clinical trial,additional reduction of PEG-ELS volume seems feasible. Enteral nutrition may simplify the process and avoid unexpected intake of fiber-containing food.

We hypothesized that dietary restriction with enteral nutrition prescribed could prevent nonadherence to dietary restrictions, enable additional reduction of the required volume of PEG-ELS.

02

Conditions studied

  • Bowel Preparation
03

In context

Lead sponsor

Ningbo No. 1 Hospital is the lead sponsor of 56 studies on the registry; 12 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. the age of 18-75year
  2. Outpatients undergoing colonoscopy
  3. Informed consent

Exclusion criteria

Exclusion Criteria:

  1. the age >75 years or \<18 years
  2. history of colectomy or bowel obstruction
  3. severe constipation (defined as stool frequerncy of 3 or less/week)
  4. current pregnancy or breastfeeding
  5. BMI >30, diabetes
  6. known allergies to cleansing agents or ingredients of Enteral nutrition
  7. inability to follow the oral bowel preparation regimen.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
248 participants (estimated)

Study arms

  • Experimental
    Enteral Nutritional+PEG

    Enteral Nutritional Powder with low volume 1.5L PEG

    Dietary Supplement: Enteral Nutrition Powder Ensure · Drug: 1.5L PEG

  • Placebo comparator
    Self-controlled diet+PEG

    Self-controlled diet with normal amount of 2L PEG

    Other: Self-controlled diet · Drug: 2L PEG

Interventions

  • Dietary supplementEnteral Nutrition Powder Ensure

    Enteral Nutrition Powder Ensure for each meal.The duration of study is one day before colonoscopy.

    Also known as: Ensure

  • Drug1.5L PEG

    Low volume PEG

    Also known as: Hengkangzhengqing

  • OtherSelf-controlled diet

    Self-controlled low residue diet.

  • Drug2L PEG

    Normal volume of PEG

    Also known as: Hengkangzhengqing

06

What researchers measure

Primary outcomes

  1. the quality of bowel preparation

    Evaluation of the quality of bowel preparation for each participant by the Ottawa bowel preparation scale(OBPS),it's a validated scoring system with scores between 0 and 14, where 0 is the best score,The score comprises a sub score 0-4 for each colon segment: right, transverse and rectosigmoid colon.n addition, a score 0-2 is added to indicate the total amount of luminal fluid.

    Time frame: 1day

Secondary outcomes

  1. patients' satisfaction with the process of bowel preparation

    At the end of the procedure, the patients were asked about the satisfaction with the process of bowel preparation. Satisfaction includes bad,not so bad and good.Bad means that the patient is not satisfied with the program, not so bad means that the patient is satisfied with the plan, and good means that the patient is very satisfied with the plan.

    Time frame: 1day

  2. patients' willingness to have the colonoscopy done again at this facility in the future

    It represent participants who wanted to choose the same protocol in the future as they received in this trial.Including yes and no two options, if yes, indicating that the patient is willing to undergo colonoscopy again, if no, indicating that the patient is reluctant to undergo colonoscopy again.

    Time frame: 1day

  3. comparison with previous experience

    If patients with colonoscopy times ≥ 2, they need to compare with previous experience,Including better than last experience, similar to the last experience, and worse than the last experience.

    Time frame: 1day

  4. adverse events

    It represent the incidence of abdominal cramping, bloating, nausea/vomiting after intake of PEG and/or enteral nutrition was compared.

    Time frame: 1day

  5. Convenience of Protocol between enteral nutrition with low volume 1.5L PEG and Self-controlled diet with normal amount of 2L PEG Protocol

    It represented the percentage of patients who thinks the protocol is easy to use.

    Time frame: 1day

07

Study locations

1 site
  • Ningbo first hospital
    Ningbo, Zhejiang 315010, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04021979
Lead sponsor
Ningbo No. 1 Hospital
Responsible party
Sponsor
First posted
Jul 16, 2019
Start date
Aug 1, 2019 (estimated)
Primary completion
Aug 1, 2019 (estimated)
Completion
Nov 1, 2019 (estimated)
Last update
Jul 16, 2019

Study contacts

Lei Xu, PhD
Contact
xulei22@163.com
+86-0574-87089840
Hongpeng Lu, master
Contact
luhongpeng2008@163.com
+86-0574-87089848
Hongpeng Lu, master
principal investigator · Department of Gastroenterology, Ningbo No. 1 Hospital, Ningbo, China

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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