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

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

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: Nutridrink 200 ml; Dietary supplement: Nutridrink compact protein

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 123103
    • ГНЦ колопроктологии

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
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; 2 bottles per day. On the day of the colonoscopy, as breakfast, allowed Nutridrink compact protein 1-2 bottles
No Intervention: Group control; only diet without receiving specialized nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Nutricia Advanced
• Investigators: Study Chair: Elena Volkova

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: March 16, 2016
• First Submitted That Met QC Criteria: March 16, 2016
• First Posted (Estimate): March 21, 2016

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 11, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: enteral feeding; colon preparation for endoscopy; sip feeding; nutridrink; nutridrink compact protein
• Other Study ID Numbers: Nutricia-001