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

NCT ID: NCT02714296

Last Updated: 2017-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-11-30

Brief Summary

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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

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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.

Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Nutridrink 200 ml

Intervention Type 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 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

Group Type ACTIVE_COMPARATOR

Nutridrink compact protein

Intervention Type DIETARY_SUPPLEMENT

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

Group control

only diet without receiving specialized nutrition

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DRUG

Nutridrink compact protein

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nutricia Advanced

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elena Volkova

Role: STUDY_CHAIR

Locations

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ГНЦ колопроктологии

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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Nutricia-001

Identifier Type: -

Identifier Source: org_study_id

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