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

Study Overview
=================
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: Compare the three methods of colon preparation for endoscopy To develop a rational strategy of preparing patients for endoscopy on the basis of the data obtained.

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

Conditions
-----------------
Colonoscopy

Intervention / Treatment
-----------------
* Drug: Nutridrink 200 ml
* Dietary Supplement: Nutridrink compact protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years with the recommendation to conduct a diagnostic colonoscopy Absence of contraindications to the use of specialized clinical nutrition products Exclusion Criteria: 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 Pregnancy The patient's refusal to participate in the study Intolerance of specialized clinical nutrition products

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group Nutridrink 200ml<br>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<br>* 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<br>|
| Active Comparator: Group Nutridrink compact protein<br>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<br>* 2 bottles per day. On the day of the colonoscopy, as breakfast, allowed Nutridrink compact protein 1-2 bottles<br>|
| No Intervention: Group control<br>only diet without receiving specialized nutrition | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the degree of preparation in the colonoscopy (Chicago or Boston scale). |  | before colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tolerability | Visual analog scale assessment of tolerability of the preparation to the study | before colonoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colon preparation for endoscopy, enteral feeding, sip feeding, nutridrink, nutridrink compact protein