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

Phase IV Prospective Sinle Center Randomised Three-arm Controlled Study Evaluating the Effectiveness of Colon Preparation for Endoscopy Using Specialized Clinical Nutrition

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02714296
Enrollment
150
Registered
2016-03-21
Start date
2016-03-31
Completion date
2016-11-30
Last updated
2017-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy

Keywords

colon preparation for endoscopy, enteral feeding, sip feeding, nutridrink, nutridrink compact protein

Brief summary

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

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.

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

Sponsors

Nutricia Advanced
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

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

Design outcomes

Primary

MeasureTime frame
the degree of preparation in the colonoscopy (Chicago or Boston scale).before colonoscopy

Secondary

MeasureTime frameDescription
tolerabilitybefore colonoscopyVisual analog scale assessment of tolerability of the preparation to the study

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026