CClinicalTrials.gg
Sign In
CompletedNCT02714296Updated Apr 13, 2017

Evaluating the Effectiveness of Colon Preparation for Endoscopy Using Specialized Clinical Nutrition

A Phase 4 interventional study of Nutridrink 200 ml and Nutridrink compact protein in Colonoscopy, sponsored by Nutricia Advanced. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-04-13.

Sponsored by Nutricia Advanced · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study is an open, prospective, comparative diagnostic studies aimed at improving the colonoscopy results, by optimizing the way of preparation for endoscopy

Read the detailed description

Objective: to improve the quality of bowel preparation for endoscopy.

Research objectives:

  1. Compare the three methods of colon preparation for endoscopy
  2. To develop a rational strategy of preparing patients for endoscopy on the basis of the data obtained.
02

Conditions studied

  • Colonoscopy

Keywords

  • colon preparation for endoscopy
  • enteral feeding
  • sip feeding
  • nutridrink
  • nutridrink compact protein
03

In context

Lead sponsor

This is the only study on the registry with Nutricia Advanced as lead sponsor.

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
No

Inclusion criteria

  1. Patients older than 18 years with the recommendation to conduct a diagnostic colonoscopy
  2. Absence of contraindications to the use of specialized clinical nutrition products

Exclusion criteria

Exclusion Criteria:

  1. Conditions which are contraindicated for colonoscopy:

    • The acute phase of cerebrovascular accident
    • Acute myocardial infarction
    • severe cardiovascular, pulmonary insufficiency and mixed
    • Violations of the cardiac rhythm (paroxysmal bradyarrhythmia, atrial fibrillation with atrial fibrillation or paroxysmal atrial fibrillation, severe transverse heart block)
    • Severe clinical forms (fulminant) inflammatory diseases of the colon (ulcerative colitis, Crohn's disease, ischemic colitis, radiation colitis, diverticulitis)
    • Aortic aneurysm or heart
    • Acute inflammatory infiltrates abdominal cavity (including diverticulitis)
    • Suspicion of abscess of the abdominal cavity
    • Peritonitis
    • Hepatosplenomegaly
    • Tense ascites
    • hydrothorax, hydropericardium
    • Severe blood coagulation
    • Hemorrhagic vasculitis
  2. Pregnancy
  3. The patient's refusal to participate in the study
  4. Intolerance of specialized clinical nutrition products
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Active comparator
    Group Nutridrink 200ml

    50 patients: two days before the investigation is assigned to a diet with the use of specialized clinical nutrition Nutridrink 200 ml 6 bottles per day as a sole source of nutrition. On the day of the colonoscopy, as breakfast, allowed Nutridrink 1-2 bottles

    Drug: Nutridrink 200 ml

  • Active comparator
    Group Nutridrink compact protein

    two days before the study is assigned diet with the addition of specialized clinical nutrition Nutridrinc compact protein 125 ml 2 bottles per day. On the day of the colonoscopy, as breakfast, allowed Nutridrink compact protein 1-2 bottles

    Dietary Supplement: Nutridrink compact protein

  • No intervention
    Group control

    only diet without receiving specialized nutrition

Interventions

  • DrugNutridrink 200 ml

    Nutridrink 200 ml 6 bottles per day as a sole source of nutrition. On the day of the colonoscopy, as breakfast, allowed Nutridrink 1-2 bottles

  • Dietary supplementNutridrink compact protein

    2 bottles per day. On the day of the colonoscopy, as breakfast, allowed Nutridrink compact protein 1-2 bottles

06

What researchers measure

Primary outcomes

  1. the degree of preparation in the colonoscopy (Chicago or Boston scale).

    Time frame: before colonoscopy

Secondary outcomes

  1. tolerability

    Visual analog scale assessment of tolerability of the preparation to the study

    Time frame: before colonoscopy

07

Study locations

1 site
  • ГНЦ колопроктологии
    Moscow, 123103, Russian Federation
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02714296
Lead sponsor
Nutricia Advanced
Responsible party
Sponsor
First posted
Mar 21, 2016
Start date
Mar 2016
Primary completion
Sep 2016
Completion
Nov 2016
Last update
Apr 13, 2017

Study contacts

Elena Volkova
study chair

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion