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

NCT02714296 | Completed Phase 4

• 1 other identifier: Nutricia-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Colonoscopy

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  before colonoscopy

Secondary Outcomes (1)

• tolerability

  before colonoscopy

Study Arms (3)

Group Nutridrink 200ml

ACTIVE COMPARATOR

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

Group Nutridrink compact protein

ACTIVE COMPARATOR

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

Group control

NO INTERVENTION

only diet without receiving specialized nutrition

Interventions

Nutridrink 200 ml DRUG

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

Group Nutridrink 200ml

Nutridrink compact protein DIETARY_SUPPLEMENT

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

Group Nutridrink compact protein

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutricia Advanced: lead

Study Sites (1)

ГНЦ колопроктологии

Moscow, 123103, Russia

Location

Study Officials

• Elena Volkova

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: March 21, 2016
• Study Start: March 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 13, 2017

Record last verified: 2017-04

Locations

RU (1)