Assessment of Safety, Quality, and Acceptance of a Bowel Preparation Using a Food Kit With Laxatives
18 de mayo de 2026 actualizado por: Joseph Spataro
A Single-Center, Randomized, Prospective, Single-Blinded Study to Assess the Safety, Quality, and Tolerance of a Bowel Preparation Using a Food Kit With Laxatives in a United States Veteran Population
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.
- Standard Bowel Prep which includes a clear liquid diet the day before the scheduled procedure and two doses of a laxative, polyethylene glycol 3350 (PEG-3350) taken with 4 liters of water.
- Happy Colon Foods Bowel Prep which begins the day before the scheduled procedure and contains various low residue foods (foods that are easily digested and absorbed), and seven doses of laxatives including PEG-3350 taken with a total of about 4 liters of water, senna tablets, and one dose of magnesium citrate.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
57
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Virginia
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Richmond, Virginia, Estados Unidos, 23249
- Central Virginia VA Health Care System
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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:
- Personal history of colorectal cancer
- Inflammatory bowel disease
- Prior colon resection
- Antithrombotic therapy precluding polypectomy
- Pregnancy
- Hospitalization at the time of the scheduled procedure
- Celiac disease (food kit contained gluten products)
- Prior colonoscopy (cognitive bias)
- Chronic kidney disease stage 3 or higher
- Age 70 years or older.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Experimental: Food Kit with Laxatives (Happy Colon Foods)
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.
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Low-residue diet food items and scheduled doses of PEG-3350, senna, and magnesium citrate prior to the colonoscopy
|
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Comparador activo: Control: Standard GoLYTELY Split-Dose Prep
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.
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Split-dose 4 L PEG-3350 electrolyte lavage solution taken the day before and morning of colonoscopy, combined with 24-hour clear liquid diet.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient acceptance/satisfaction
Periodo de tiempo: Periprocedural
|
Measure: Scores on a designed survey evaluating acceptance, ease of following instructions and willingness to repeat the preparation.
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Periprocedural
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Quality of bowel preparation
Periodo de tiempo: During colonoscopy (single procedure)
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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.
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During colonoscopy (single procedure)
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Patient-reported symptoms during bowel preparation
Periodo de tiempo: Periprocedural
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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).
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Periprocedural
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Adverse events during bowel preparation
Periodo de tiempo: Periprocedural
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Proportion of subjects with adverse events, defined as any symptom scored as 5 (severely distressing) on the Likert scale.
|
Periprocedural
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Irrigation and suction time
Periodo de tiempo: Periprocedural
|
Time spent on irrigation and suction during colonoscopy, measured in minutes
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Periprocedural
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Colonoscopy withdrawal time
Periodo de tiempo: Periprocedural
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Time from cecum to scope removal, measured in minutes
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Periprocedural
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Total colonoscopy procedure time
Periodo de tiempo: Periprocedural
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Total time from scope insertion to removal, measured in minutes
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Periprocedural
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Cecal intubation rate
Periodo de tiempo: Periprocedural
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Proportion of subjects with successful cecal intubation
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Periprocedural
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Adenoma detection rate
Periodo de tiempo: Periprocedural
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Proportion of subjects with at least one adenoma detected
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Periprocedural
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Adenomas per colonoscopy
Periodo de tiempo: Periprocedural
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Mean number of adenomas detected per colonoscopy
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Periprocedural
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Presence of diverticulosis
Periodo de tiempo: Periprocedural
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Proportion of subjects with diverticulosis identified during colonoscopy
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Periprocedural
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Time to first bowel movement
Periodo de tiempo: Periprocedural
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Interval from ingestion of bowel preparation laxative to the first bowel movement
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Periprocedural
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Lebwohl B, Kastrinos F, Glick M, Rosenbaum AJ, Wang T, Neugut AI. The impact of suboptimal bowel preparation on adenoma miss rates and the factors associated with early repeat colonoscopy. Gastrointest Endosc. 2011 Jun;73(6):1207-14. doi: 10.1016/j.gie.2011.01.051. Epub 2011 Apr 8.
- Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.
- Scaglione G, Pietrini L, Russo F, Franco MR, Sorrentini I. Long-acting octreotide as rescue therapy in chronic bleeding from gastrointestinal angiodysplasia. Aliment Pharmacol Ther. 2007 Sep 15;26(6):935-42. doi: 10.1111/j.1365-2036.2007.03435.x.
- Kluge MA, Williams JL, Wu CK, Jacobson BC, Schroy PC 3rd, Lieberman DA, Calderwood AH. Inadequate Boston Bowel Preparation Scale scores predict the risk of missed neoplasia on the next colonoscopy. Gastrointest Endosc. 2018 Mar;87(3):744-751. doi: 10.1016/j.gie.2017.06.012. Epub 2017 Jun 23.
- 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.
- 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.
- 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.
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- Othman F, Crooks CJ, Card TR. The risk of Clostridium difficile infection in patients with pernicious anaemia: a retrospective cohort study using primary care database. United European Gastroenterol J. 2017 Nov;5(7):959-966. doi: 10.1177/2050640617695697. Epub 2017 Feb 21.
- Chak A, Cooper GS, Canto MI, Pollack BJ, Sivak MV Jr. Enteroscopy for the initial evaluation of iron deficiency. Gastrointest Endosc. 1998 Feb;47(2):144-8. doi: 10.1016/s0016-5107(98)70347-5.
- Vetter B, Gasch B, Padosch SA. [Coping with complex medical emergency situations : Competent and successful decision-making, communication and leadership]. Anaesthesist. 2015 Apr;64(4):298-303. doi: 10.1007/s00101-015-2423-2. German.
- Smith MM, Hayes AJ, Melrose J. Pentosan Polysulfate, a Semisynthetic Heparinoid Disease-Modifying Osteoarthritic Drug with Roles in Intervertebral Disc Repair Biology Emulating the Stem Cell Instructive and Tissue Reparative Properties of Heparan Sulfate. Stem Cells Dev. 2022 Aug;31(15-16):406-430. doi: 10.1089/scd.2022.0007. Epub 2022 Mar 14.
- 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.
- Rotolo F, Vitiello V, Pellegrini D, Carotenuto Y, Buttino I. Historical control data in ecotoxicology: Eight years of tests with the copepod Acartia tonsa. Environ Pollut. 2021 Sep 1;284:117468. doi: 10.1016/j.envpol.2021.117468. Epub 2021 May 27.
- Raulf-Heimsoth M, Rihs HP, Rozynek P, Cremer R, Gaspar A, Pires G, Yeang HY, Arif SA, Hamilton RG, Sander I, Lundberg M, Bruning T. Quantitative analysis of immunoglobulin E reactivity profiles in patients allergic or sensitized to natural rubber latex (Hevea brasiliensis). Clin Exp Allergy. 2007 Nov;37(11):1657-67. doi: 10.1111/j.1365-2222.2007.02833.x. Epub 2007 Sep 19.
- Robertson GS, Ristic CD, Bullen BR. The incidence of congenitally absent foot pulses. Ann R Coll Surg Engl. 1990 Mar;72(2):99-100.
- Kahl S, Zimmermann S, Genz I, Glasbrenner B, Pross M, Schulz HU, Mc Namara D, Schmidt U, Malfertheiner P. Risk factors for failure of endoscopic stenting of biliary strictures in chronic pancreatitis: a prospective follow-up study. Am J Gastroenterol. 2003 Nov;98(11):2448-53. doi: 10.1111/j.1572-0241.2003.08667.x.
- Parsons TM, Satchithananda K, Berbe R, Siddiqui IA, Robinson E, Hart AJ. [MRI investigations in patients with problems due to metal-on-metal implants]. Orthopade. 2013 Aug;42(8):629-36. doi: 10.1007/s00132-012-2036-2. German.
- Riemann JF. Colorectal cancer screening in Europe: compliance and the choice of test. Endoscopy. 2010 Jul;42(7):576-7. doi: 10.1055/s-0030-1255542. Epub 2010 Jun 30. No abstract available.
- Klein EY. Antimalarial drug resistance: a review of the biology and strategies to delay emergence and spread. Int J Antimicrob Agents. 2013 Apr;41(4):311-7. doi: 10.1016/j.ijantimicag.2012.12.007. Epub 2013 Feb 8.
- Chave SP. The Duncan memorial lecture. 'Duncan of Liverpool--and some lessons for today'. Community Med. 1984 Feb;6(1):61-71. No abstract available.
- See CC, Newman LJ, Berezin S, Glassman MS, Medow MS, Dozor AJ, Schwarz SM. Gastroesophageal reflux-induced hypoxemia in infants with apparent life-threatening event(s). Am J Dis Child. 1989 Aug;143(8):951-4.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de noviembre de 2022
Finalización primaria (Actual)
24 de junio de 2025
Finalización del estudio (Actual)
24 de junio de 2025
Fechas de registro del estudio
Enviado por primera vez
11 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
18 de mayo de 2026
Publicado por primera vez (Actual)
26 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
18 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRBNet ID: 1689988
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .