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| Name | Class |
|---|---|
| Happy Colon Foods | UNKNOWN |
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The main purpose of this research study is to learn if an alternative bowel preparation (bowel prep) for colonoscopy is safe, tolerable and effective as compared to the standard bowel prep.
Participants are randomly assigned to receive one of the following bowel cleansing regimens for colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Food Kit with Laxatives (Happy Colon Foods) | Experimental | Patients receive a commercially available prepackaged food and laxative kit (Happy Colon Foods) starting 24 hours before colonoscopy, including a low-residue diet and intermittent laxative regimen with PEG-3350 powder, senna tablets, and a single dose of magnesium citrate, following written and visual instructions. |
|
| Control: Standard GoLYTELY Split-Dose Prep | Active Comparator | Patients receive standard colonoscopy bowel preparation using a clear liquid diet for 24 hours before the procedure and split-dose 4 L polyethylene glycol 3350 electrolyte solution (PEG-3350; GoLYTELY) prior to the scheduled colonoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of a standardized meal content (food-kit) the day prior to colonoscopy | Other | Low-residue diet food items and scheduled doses of PEG-3350, senna, and magnesium citrate prior to the colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Patient acceptance/satisfaction | Measure: Scores on a designed survey evaluating acceptance, ease of following instructions and willingness to repeat the preparation. | Periprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of bowel preparation | Measure: Boston Bowel Preparation Scale (BBPS) score in right, transverse, and left colon; total score 0-9. Adequate bowel preparation defined as total BBPS ≥ 6 with each segment score ≥ 2; proportion of patients achieving adequate prep compared between groups. | During colonoscopy (single procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| Irrigation and suction time | Time spent on irrigation and suction during colonoscopy, measured in minutes | Periprocedural |
| Colonoscopy withdrawal time | Time from cecum to scope removal, measured in minutes |
Inclusion Criteria:
- Veterans undergoing index colonoscopy for colorectal cancer screening, including follow-up colonoscopy after a positive non-invasive stool-based test (e.g., fecal immunochemical test)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Virginia VA Health Care System | Richmond | Virginia | 23249 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34209886 | Background | Lahti H, Lyyra N, Hietajarvi L, Villberg J, Paakkari L. Profiles of Internet Use and Health in Adolescence: A Person-Oriented Approach. Int J Environ Res Public Health. 2021 Jun 29;18(13):6972. doi: 10.3390/ijerph18136972. | |
| 28282690 | Background | Gimeno-Garcia AZ, Baute JL, Hernandez G, Morales D, Gonzalez-Perez CD, Nicolas-Perez D, Alarcon-Fernandez O, Jimenez A, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Carrillo M, Ramos L, Quintero E. Risk factors for inadequate bowel preparation: a validated predictive score. Endoscopy. 2017 Jun;49(6):536-543. doi: 10.1055/s-0043-101683. Epub 2017 Mar 10. |
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Individual participant data from this single-center VA study will not be shared outside the institution due to privacy and confidentiality protections for Veterans and lack of an approved external data-sharing mechanism. Aggregate results will be disseminated through presentations and peer-reviewed publications.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 23, 2022 |
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Feasibility study comparing low-fiber vs clear-liquid diet before colonoscopy
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single-blinded endoscopist
| Polyethylene glycol 3350 - electrolyte solution (GoLYTELY) | Drug | Split-dose 4 L PEG-3350 electrolyte lavage solution taken the day before and morning of colonoscopy, combined with 24-hour clear liquid diet. |
|
| Patient-reported symptoms during bowel preparation |
Patient-reported symptoms (abdominal pain, cramping, bloating, nausea, vomiting, headaches, weakness, hunger, sleep difficulties) scored on a 5-point Likert scale (1 = none to 5 = severely distressing). |
| Periprocedural |
| Adverse events during bowel preparation | Proportion of subjects with adverse events, defined as any symptom scored as 5 (severely distressing) on the Likert scale. | Periprocedural |
| Periprocedural |
| Total colonoscopy procedure time | Total time from scope insertion to removal, measured in minutes | Periprocedural |
| Cecal intubation rate | Proportion of subjects with successful cecal intubation | Periprocedural |
| Adenoma detection rate | Proportion of subjects with at least one adenoma detected | Periprocedural |
| Adenomas per colonoscopy | Mean number of adenomas detected per colonoscopy | Periprocedural |
| Presence of diverticulosis | Proportion of subjects with diverticulosis identified during colonoscopy | Periprocedural |
| Time to first bowel movement | Interval from ingestion of bowel preparation laxative to the first bowel movement | Periprocedural |
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| 29421724 | Background | Hu S, Gong T, Ma J, Tao Y, Xian Q. Simultaneous determination of iodinated haloacetic acids and aromatic iodinated disinfection byproducts in waters with a new SPE-HPLC-MS/MS method. Chemosphere. 2018 May;198:147-153. doi: 10.1016/j.chemosphere.2018.01.124. Epub 2018 Feb 3. |
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| 28555630 | Background | Rex DK, Boland CR, Dominitz JA, Giardiello FM, Johnson DA, Kaltenbach T, Levin TR, Lieberman D, Robertson DJ. Colorectal Cancer Screening: Recommendations for Physicians and Patients from the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2017 Jul;112(7):1016-1030. doi: 10.1038/ajg.2017.174. Epub 2017 Jun 6. |
| May 18, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 23, 2022 | May 18, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| C033608 | Golytely |
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