ColonoscopyPhase 4NCT02714296
Evaluating the Effectiveness of Colon Preparation for Endoscopy Using Specialized Clinical Nutrition
A Phase 4 study testing Nutridrink 200 ml and Nutridrink compact protein in people with Colonoscopy, run by Nutricia Advanced at 1 site in Russia.
Trial summary
This study is an open, prospective, comparative diagnostic studies aimed at improving the colonoscopy results, by optimizing the way of preparation for endoscopy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Nutridrink 200 ml and Nutridrink compact protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- Mar 2016to Nov 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years with the recommendation to conduct a diagnostic colonoscopy
- Absence of contraindications to the use of specialized clinical nutrition products
Who cannot join
- 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)
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- 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
- Pregnancy
- The patient's refusal to participate in the study
- Intolerance of specialized clinical nutrition products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the detailed description
Objective: to improve the quality of bowel preparation for endoscopy.
Research objectives:
- Compare the three methods of colon preparation for endoscopy
- To develop a rational strategy of preparing patients for endoscopy on the basis of the data obtained.
- Conditions
- Colonoscopy
- Being tested
- Nutridrink 200 ml, Nutridrink compact protein
- Keywords
- colon preparation for endoscopy, enteral feeding, sip feeding, nutridrink, nutridrink compact protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutridrink 200 mlDrug
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
Nutridrink compact proteinDietary supplement
2 bottles per day. On the day of the colonoscopy, as breakfast, allowed Nutridrink compact protein 1-2 bottles
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Nutridrink compact protein |
| Group control | No intervention | only diet without receiving specialized nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
the degree of preparation in the colonoscopy (Chicago or Boston scale).
Measured: before colonoscopy
Secondary outcomes (1)
tolerability
Visual analog scale assessment of tolerability of the preparation to the study
Measured: before colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia Advanced
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elena Volkova, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714296
- Sponsor's protocol ID
- Nutricia-001
- Status last verified
- Apr 2017
- First submitted
- 16 Mar 2016
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Prospective Sinle Center Randomised Three-arm Controlled Study Evaluating the Effectiveness of Colon Preparation for Endoscopy Using Specialized Clinical Nutrition
- ClinicalTrials.gov ID
- NCT02714296
- Acronym / sponsor ID
- Nutricia-001
- Conditions
- Colonoscopy
- Keywords
- colon preparation for endoscopy, enteral feeding, sip feeding, nutridrink, nutridrink compact protein
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Nutricia AdvancedIndustry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Objective: to improve the quality of bowel preparation for endoscopy.
Research objectives:
- Compare the three methods of colon preparation for endoscopy
- To develop a rational strategy of preparing patients for endoscopy on the basis of the data obtained.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Nutridrink 200ml | Active comparator | Drug: Nutridrink 200 ml50 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 Nutridrink compact protein | Active comparator | Dietary Supplement: Nutridrink compact proteintwo 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 control | No intervention | –only diet without receiving specialized nutrition |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients older than 18 years with the recommendation to conduct a diagnostic colonoscopy
- Absence of contraindications to the use of specialized clinical nutrition products
Key exclusion criteria (18 listed)
- Conditions which are contraindicated for colonoscopy:
- Pregnancy
- The patient's refusal to participate in the study
- Intolerance of specialized clinical nutrition products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutridrink 200 mlNutridrink 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 | Group Nutridrink 200ml |
| Nutridrink compact protein2 bottles per day. On the day of the colonoscopy, as breakfast, allowed Nutridrink compact protein 1-2 bottles | Dietary supplement | Group Nutridrink compact protein |
Primary outcome
the degree of preparation in the colonoscopy (Chicago or Boston scale).
Time frame: before colonoscopy
1 secondary outcome
tolerability
Time frame: before colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Volkova study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nutridrink 200 ml and Nutridrink compact protein in people with Colonoscopy, run by Nutricia Advanced at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the degree of preparation in the colonoscopy (Chicago or Boston scale). (time frame: before colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.