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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714296
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Nutricia Advanced

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

Condition or disease Intervention/treatment Phase
Colonoscopy Drug: Nutridrink 200 ml Dietary Supplement: Nutridrink compact protein Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Phase IV Prospective Sinle Center Randomised Three-arm Controlled Study Evaluating the Effectiveness of Colon Preparation for Endoscopy Using Specialized Clinical Nutrition
Actual Study Start Date : March 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. the degree of preparation in the colonoscopy (Chicago or Boston scale). [ Time Frame: before colonoscopy ]

Secondary Outcome Measures :
  1. tolerability [ Time Frame: before colonoscopy ]
    Visual analog scale assessment of tolerability of the preparation to the study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714296


Locations
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Russian Federation
ГНЦ колопроктологии
Moscow, Russian Federation, 123103
Sponsors and Collaborators
Nutricia Advanced
Investigators
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Study Chair: Elena Volkova
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Responsible Party: Nutricia Advanced
ClinicalTrials.gov Identifier: NCT02714296    
Other Study ID Numbers: Nutricia-001
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Keywords provided by Nutricia Advanced:
colon preparation for endoscopy
enteral feeding
sip feeding
nutridrink
nutridrink compact protein