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

Nutricia

Status and phase: Completed; Phase 4

Conditions: Colonoscopy

Treatments: Dietary Supplement: Nutridrink compact protein; Drug: Nutridrink 200 ml

Study type: Interventional

Funder types: Industry

Identifiers

NCT02714296

Nutricia-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Group Nutridrink 200ml

Active Comparator group

Description:

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

Treatment:

Drug: Nutridrink 200 ml

Group Nutridrink compact protein

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Nutridrink compact protein

Group control

No Intervention group

Description:

only diet without receiving specialized nutrition