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

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02714296
• Other study ID #: Nutricia-001
• Status: Completed
• Phase: Phase 4
• First received: March 16, 2016
• Last updated: April 11, 2017
• Start date: March 2016
• Est. completion date: November 2016

Study information

• Verified date: April 2017
• Source: Nutricia Advanced
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopy

Intervention

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

Locations

Country	Name	City	State
Russian Federation	??? ???????????????	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia Advanced

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the degree of preparation in the colonoscopy (Chicago or Boston scale).		before colonoscopy
Secondary	tolerability	Visual analog scale assessment of tolerability of the preparation to the study	before colonoscopy