Colon Cancer ScreeningPhase 4NCT07351019
Colonoscopy Bowel Prep Comparison Among Diabetic Patients
A Phase 4 study testing Golytely and SUPRPEP in people with Colon Cancer Screening, run by Eisenhower Army Medical Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if the Golytely or SUPREP bowel preparation works more effectively in bowel cleansing for colorectal cancer screening with colonoscopy in patients with diabetes. The main questions this study aims to answer are: 1. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer Screening
- What is being tested?
- Golytely and SUPRPEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2026to 28 Jul 2026
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants having provided informed consent with signature on informed consent form: the informed consent process should be complete with full discussion of all requirements and possible risks.
- Diabetic volunteer (defined per current ACP guidelines, and any type of DM)
- Aged 18+ years, inclusive
- Average screening risk, polyp surveillance, and family history of cancer
Who cannot join
- Unable to provide informed consent to participate in the study Such as a mental condition rendering the participant unable to understand the nature, scope, and possible consequences of the study
- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the participant at risk by participating in the study
- Persistent significant or severe infection, either acute or chronic
- Prior use of any investigational drug in the preceding 6 months
- Liver function impairment or persisting elevations (confirmed by retest) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or direct bilirubin greater than 2x the upper limit of normal range (ULN).
- Pregnant or breast-feeding women or those who plan to become pregnant during the study
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- Participants with significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia (confirmed by retest):
- Hematocrit < 35% and/or
- Absolute white blood cell count < 3000 cells/mm3 ( L) and/or
- Platelet count < 150 000 cells/mm3 ( L) and/or- Absolute neutrophil = 1500 cells/mm3 ( L)
- History of colorectal cancer
- Inflammatory Bowel Disease
- Past surgical history of colon resection
- Prior history of colorectal surgery
- Family history of hereditary polyposis and cancer disorders to include but not limited to FAP (Familial Adenomatous Polyposis), Gardner Syndrome, Turcot Syndrome, Lynch Syndrome, Cowden Syndrome, and Peutz-Jeghers Syndrome
- Symptomatic patients (bleeding, diarrhea, constipation, abdominal pain)
Trial locations and contacts
1 site in 1 country.
United States1 site
Dwight D. Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905
About this study
Official title: Colonoscopy Bowel Prep Comparison Among Diabetic Patients: Golytely v. SUPREP
The goal of this clinical trial is to learn if the Golytely or SUPREP bowel preparation works more effectively in bowel cleansing for colorectal cancer screening with colonoscopy in patients with diabetes. The main questions this study aims to answer are:
- Is there a significant difference in bowel prep cleanse between Golytely and SUPREP in patients with diabetes based on the Boston Bowel Prep Score (BBPS) as assessed by blinded, skilled endoscopists?
- Is there a significant difference in patients' tolerance between the bowel preparations as assessed by the validated Mayo Bowel Prep Tolerability Form (MBPTF)?
Read more
Participants will:
- Be randomized to take either Golytely or SUPREP bowel preparation prior to their colonoscopy
- Complete the MBPTF on the procedure date prior to the scheduled colonoscopy
- Undergo a standardized screening colonoscopy during which time a blinded endoscopist will document the participant's BBPS
The research team hypothesizes that SUPREP will have a significant difference in tolerability (based on MBPTF), while exhibiting no difference in bowel cleanse (based on BBPS) in the diabetic patient population.
- Conditions
- Colon Cancer Screening
- Being tested
- Golytely, SUPRPEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GolytelyDrug
Bowel cleanliness and patient tolerability
SUPRPEPDrug
Bowel cleanliness and patient tolerability
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients undergoing bowel prep for screening colonoscopy using Golytely | Active comparator | Not described Receives: Drug: Golytely |
| Diabetic patients undergoing bowel prep for screening colonoscopy using SUPREP | Active comparator | Not described Receives: Drug: SUPRPEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel cleanliness using the Boston Bowel Prep Score (BBPS)
The BBPS uses a score from 0-9 which helps quantify bowel cleanliness after bowel prep prior to colonoscopy. A higher score indicates better visualization of the colon mucosa. This will be assessed by blinded, skilled endoscopists.
Measured: Procedural (during the participant's screening colonoscopy)
Use of the Mayo Bowel Prep Tolerability Score (MTS)
The questionnaire is a validated scoring system used to assess the tolerability (ex. symptoms) and experience (ex. likelihood of using the bowel prep again) among diabetic patients undergoing the study.
Measured: Pre-procedural (prior to the participant's screening colonoscopy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start16 Jan 2026
- Primary completion28 Jul 2026
- Study completion28 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer ScreeningStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisenhower Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Darrell F. Barker, MD, FACG, Eisenhower Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351019
- Sponsor's protocol ID
- DDEAMC.2022.0044
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonoscopy Bowel Prep Comparison Among Diabetic Patients: Golytely v. SUPREP
- ClinicalTrials.gov ID
- NCT07351019
- Acronym / sponsor ID
- DDEAMC.2022.0044
- Conditions
- Colon Cancer Screening
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Eisenhower Army Medical CenterUS federal agency
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- 28 Jul 2026 (actual)
- Study completion
- 28 Jul 2026 (actual)
- First posted
- 20 Jan 2026 (actual)
- 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.
The goal of this clinical trial is to learn if the Golytely or SUPREP bowel preparation works more effectively in bowel cleansing for colorectal cancer screening with colonoscopy in patients with diabetes. The main questions this study aims to answer are:
- Is there a significant difference in bowel prep cleanse between Golytely and SUPREP in patients with diabetes based on the Boston Bowel Prep Score (BBPS) as assessed by blinded, skilled endoscopists?
- Is there a significant difference in patients' tolerance between the bowel preparations as assessed by the validated Mayo Bowel Prep Tolerability Form (MBPTF)?
Participants will:
- Be randomized to take either Golytely or SUPREP bowel preparation prior to their colonoscopy
- Complete the MBPTF on the procedure date prior to the scheduled colonoscopy
- Undergo a standardized screening colonoscopy during which time a blinded endoscopist will document the participant's BBPS
The research team hypothesizes that SUPREP will have a significant difference in tolerability (based on MBPTF), while exhibiting no difference in bowel cleanse (based on BBPS) in the diabetic patient population.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients undergoing bowel prep for screening colonoscopy using Golytely | Active comparator | Drug: Golytely |
| Diabetic patients undergoing bowel prep for screening colonoscopy using SUPREP | Active comparator | Drug: SUPRPEP |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Participants having provided informed consent with signature on informed consent form: the informed consent process should be complete with full discussion of all requirements and possible risks.
- Diabetic volunteer (defined per current ACP guidelines, and any type of DM)
- Aged 18+ years, inclusive
- Average screening risk, polyp surveillance, and family history of cancer
Key exclusion criteria (16 listed)
- Unable to provide informed consent to participate in the study Such as a mental condition rendering the participant unable to understand the nature, scope, and possible consequences of the study
- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the participant at risk by participating in the study
- Persistent significant or severe infection, either acute or chronic
- Prior use of any investigational drug in the preceding 6 months
- Liver function impairment or persisting elevations (confirmed by retest) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or direct bilirubin greater than 2x the upper limit of normal range (ULN).
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 |
|---|---|---|
| GolytelyBowel cleanliness and patient tolerability | Drug | Diabetic patients undergoing bowel prep for screening colonoscopy using Golytely |
| SUPRPEPBowel cleanliness and patient tolerability | Drug | Diabetic patients undergoing bowel prep for screening colonoscopy using SUPREP |
Primary outcome
Bowel cleanliness using the Boston Bowel Prep Score (BBPS)
Time frame: Procedural (during the participant's screening colonoscopy)
The BBPS uses a score from 0-9 which helps quantify bowel cleanliness after bowel prep prior to colonoscopy. A higher score indicates better visualization of the colon mucosa. This will be assessed by blinded, skilled endoscopists.
Use of the Mayo Bowel Prep Tolerability Score (MTS)
Time frame: Pre-procedural (prior to the participant's screening colonoscopy)
The questionnaire is a validated scoring system used to assess the tolerability (ex. symptoms) and experience (ex. likelihood of using the bowel prep again) among diabetic patients undergoing the study.
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 6 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Golytely and SUPRPEP in people with Colon Cancer Screening, run by Eisenhower Army Medical Center at 1 site in United States.
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 4 inclusion and 16 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 6 Aug 2026. 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 United States. 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?
Bowel cleanliness using the Boston Bowel Prep Score (BBPS) (time frame: Procedural (during the participant's screening colonoscopy)). The study lists 2 primary outcomes in all. 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 6 Aug 2026.