NCT00675324

Brief Summary

Bowel preparation can be a troublesome procedure for patients undergoing colonoscopy. For patients with cardio-vascular and kidney disorders it may be dangerous with traditional bowel preparation with regard to salt and electrolyte balance. This study's purpose is to find out if nutritional drinks can replace traditional bowel preparation before colonoscopy in regard to Bowel purity degree, disturbances in the salt and electrolyte balance in the nutritional group versus the group that gets traditional bowel preparation. And if the patients tolerate nutritional drinks better than traditional bowel preparation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 7, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

September 18, 2012

Status Verified

September 1, 2012

Enrollment Period

1.5 years

First QC Date

May 7, 2008

Last Update Submit

September 17, 2012

Conditions

ColonoscopyBowel Preparation

Keywords

ColonoscopyBowel preparationSalt and electrolyte balancePatients undergoing colonoscopyComplication with traditional bowel preparationBowel purity degree without traditional bowel preparation

Outcome Measures

Primary Outcomes (1)

  • Bowel purity degree

    day of coclonscopy

Secondary Outcomes (1)

  • Reduction of complications for patients with cardio- vascular and kidney diseases

    day of cocloscopy

Study Arms (2)

A

ACTIVE COMPARATOR

Traditional bowel preparation with Laxabon

Drug: Laxabon

B

ACTIVE COMPARATOR

Bowel preparation with nutritional drinks

Dietary Supplement: Fresubin Energy drink

Interventions

LaxabonDRUG

Laxabon 4 litres, starting the day (e.m.) before the colonoscopy

A
Fresubin Energy drinkDIETARY_SUPPLEMENT

30 kcal/kg\*day five days before colonoscopy

B

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men
  • women
  • age 18-90 years

You may not qualify if:

  • patients under 18 years
  • acute colitis
  • acute ileus
  • seriously dementia
  • patients from other counties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ersta Hospital,

Stockholm, Stockholm County, SE-116 91, Sweden

Location

Study Officials

  • Ulf Gustafsson, PhD, MD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 7, 2008

First Posted

May 9, 2008

Study Start

April 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

September 18, 2012

Record last verified: 2012-09

Locations

SE(1)