AzTrials
AzTrials

Bowel PreparationNCT03112967

Safety and Efficacy of Low-volume Preparation in the Elderly: Oral Sulfate Solution

A study testing low-volume preparation, oral sulfate solution and large-volume preparation, 4L polyethylene glycol in people with Bowel Preparation, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The investigators will investigate the safety and efficacy of low-volume preparation (Oral Sulfate solution) compared to 4L PEG solution in bowel preparation before colonoscopy. One aim of this study was to investigate the efficacy of low-volume preparation (Oral Sulfate solution) on bowel preparation before… Read more about this study

Who is it for?
Ages 65 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Bowel Preparation
What is being tested?
low-volume preparation, oral sulfate solution and large-volume preparation, 4L polyethylene glycol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
193 participants
Where
1 siteSouth Korea
Study dates
20 Apr 2017to 13 Aug 2017
Phase
Interventional
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 65 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • All participants from 65 to 75 age

Who cannot join

  • Underwent Colorectal surgery
  • CHF, Acute MI <6 months
  • ASA class III =<
  • LC, CRF, Ascite, IBD, or Severe inflammatory state
  • Severe constipation (Bowel movement 3/wk > or Taking stool softener)
  • Disabled person physically or mentally
  • Refuse consent

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Department of Internal Medicine, Kyung Hee University College of Medicine

    Seoul, 05278

Other trials in South Korea

About this study

Official title: Safety and Efficacy of Low-volume Preparation in the Elderly: Oral Sulfate Solution vs 4L PEG Dolution

The investigators will investigate the safety and efficacy of low-volume preparation (Oral Sulfate solution) compared to 4L PEG solution in bowel preparation before colonoscopy.

One aim of this study was to investigate the efficacy of low-volume preparation (Oral Sulfate solution) on bowel preparation before colonoscopy.

Read the detailed description

Traditionally, polyethylene glycol (PEG) solution, which requires ingestion of a large volume of liquid, has been used and now to a low-volume preparations because of its clear advantages in tolerability. The tolerability of bowel preparations is related to their volume, taste, and side effects, with this being a particular problem in the elderly. Meanwhile, a new oral sulfate solution (OSS, SUPREP, Braintree Laboratories, Braintree, Mass) formulation as an effective low-volume bowel cleansing agent, with a split-dose regimen was recently developed in 2009.

Concerned about being able to better complete ingestion of bowel cleansing agent, OSS with lower volume and improved taste features, as long as it does not sacrifice safety, shuld be a better choice than PEG. Many studies have already looked at the efficacy and safety of OSS compared to PEG in average risk population, but there are no data available in solely at the elderly population. In this context, we hypothesized that OSS could be a good alternative to a standard 4L-PEG solution in elderly patients.

In this report, we describe a multicenter, prospective, investigator-blind, randomized, controlled trial investigating OSS with 4L PEG for efficacy and safety in the elderly.

Being tested
low-volume preparation, oral sulfate solution, large-volume preparation, 4L polyethylene glycol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • low-volume preparation, oral sulfate solutionOther

    Also called Suprep

    Oral Sulfate solution (Suprep) in day before and split-dose regimens In the OSS arm: between 17:00 and 18:00 hours on the day before colonoscopy, subjects were instructed to pour one 180-ml bottle of the study medication into a provided 480-ml mixing cup and fill it with water and then drink the entire volume, followed by two additional 480 ml of water. At approximately 6:00 a.m. on the following morning, the subjects took the second dose of OSS by same formulation protocol.

  • large-volume preparation, 4L polyethylene glycolOther

    Also called Colyte

    4L PEG solution in day before and split-dose regimens In the 4L PEG arm: subjects had the first 2L between 18:00 and 19:00 hours (250mL every 15 minutes) in the evening before the colonoscopy. And the second 2L was given between 07:00 and 08:00 on the day of colonoscopy.

Study groups in NCT03112967
Study groupRoleWhat they receive
OSS(Suprep)ExperimentalOral Sulfate solution (Suprep) in day before and split-dose regimens In the OSS arm: between 17:00 and 18:00 hours on the day before colonoscopy, subjects were instructed to pour one 180-ml bottle of the study medication into a provided 480-ml mixing cup and fill it with water and then drink the entire volume, followed by two additional 480 ml of water. At approximately 6:00 a.m. on the following morning, the subjects took the second dose of OSS by same formulation protocol.
Receives: Other: low-volume preparation, oral sulfate solution
4L PEG solution(Colyte)Active comparator4L PEG solution in day before and split-dose regimens In the 4L PEG arm: subjects had the first 2L between 18:00 and 19:00 hours (250mL every 15 minutes) in the evening before the colonoscopy. And the second 2L was given between 07:00 and 08:00 on the day of colonoscopy.
Receives: Other: large-volume preparation, 4L polyethylene glycol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy in bowel preparation

    The boston bowel preparation scale The BBPS uses a 10-point (0-9) summation scale assessing bowel preparation quality, by a 3 point scoring system of 0 to 3 in 3 segments of the colon (right colon, transverse colon, and left colon), where 0 = ''unprepared colon with mucosa not seen because of solid stool,'' 1 = ''portion of colonic mucosa of the segment seen, but other areas not well seen due to staining, residual stool, and/or opaque liquid,'' 2 = ''minor amount of residual staining, stool, and/or opaque liquid, but colonic mucosa of the segment seen well,'' and 3 = ''entire colonic mucosa seen well with no residual staining, stool or opaque liquid.'' An adequate bowel preparation was defined by a total BBPS score ≥ 6 with all segment scores ≥ 2, and excellent cleansing was considered as a score of > 7.

    Measured: Up to 2 months

Secondary outcomes (2)

  1. Adverse events

    Proportion of adverse events. Adverse events recorded on the questionnaires included nausea, vomiting, abdominal pain, bloating, sleep disturbance, numbness, weakness/faint feeling, fecal incontinence, and thirsty.

    Blood samples were taken at the screening visit and the day of the procedure and were analysed for serum electrolytes (sodium, potassium, chloride, calcium, phosphate and magnesium), blood urea nitrogen (BUN), creatinine and glomerular filtration rate (GFR). Incident kidney injury was defined as a 25% increase in serum creatinine levels or longitudinal significant change in estimated glomerular filtration rate.

    Measured: Up to 2 months

  2. compliance and acceptability

    proportion of patients willingness

    Measured: Up to 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2017
  2. Study start20 Apr 2017
  3. Primary completion13 Aug 2017
  4. Study completion13 Aug 2017

Resources

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 N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
193 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03112967
Sponsor's protocol ID
2016-03-021
Status last verified
Aug 2017
First submitted
30 Mar 2017
Last updated
16 Aug 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Will not share datas

Publications

  • Kwak MS, Cha JM, Yang HJ, Park DI, Kim KO, Lee J, Shin JE, Joo YE, Park J, Byeon JS, Kim HG. Safety and Efficacy of Low-Volume Preparation in the Elderly: Oral Sulfate Solution on the Day before and Split-Dose Regimens (SEE SAFE) Study. Gut Liver. 2019 Mar 15;13(2):176-182. doi: 10.5009/gnl18214.

    PubMed 30400725

Questions about this trial

What is this clinical trial studying?

A study testing low-volume preparation, oral sulfate solution and large-volume preparation, 4L polyethylene glycol in people with Bowel Preparation, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.

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 1 inclusion and 7 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 16 Aug 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 South Korea. 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.

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?

Efficacy in bowel preparation (time frame: Up to 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03112967, which also lists 1 linked publication.

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 16 Aug 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in