Assessment of Safety, Quality, and Acceptance of a Bowel Preparation Using a Food Kit With Laxatives
18 maj 2026 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
57
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Virginia
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Richmond, Virginia, Förenta staterna, 23249
- Central Virginia VA Health Care System
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Low-residue diet food items and scheduled doses of PEG-3350, senna, and magnesium citrate prior to the colonoscopy
|
|
Aktiv komparator: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient acceptance/satisfaction
Tidsram: Periprocedural
|
Measure: Scores on a designed survey evaluating acceptance, ease of following instructions and willingness to repeat the preparation.
|
Periprocedural
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Quality of bowel preparation
Tidsram: During colonoscopy (single procedure)
|
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
Tidsram: 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).
|
Periprocedural
|
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Adverse events during bowel preparation
Tidsram: Periprocedural
|
Proportion of subjects with adverse events, defined as any symptom scored as 5 (severely distressing) on the Likert scale.
|
Periprocedural
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Irrigation and suction time
Tidsram: Periprocedural
|
Time spent on irrigation and suction during colonoscopy, measured in minutes
|
Periprocedural
|
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Colonoscopy withdrawal time
Tidsram: Periprocedural
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Time from cecum to scope removal, measured in minutes
|
Periprocedural
|
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Total colonoscopy procedure time
Tidsram: Periprocedural
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Total time from scope insertion to removal, measured in minutes
|
Periprocedural
|
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Cecal intubation rate
Tidsram: Periprocedural
|
Proportion of subjects with successful cecal intubation
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Periprocedural
|
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Adenoma detection rate
Tidsram: Periprocedural
|
Proportion of subjects with at least one adenoma detected
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Periprocedural
|
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Adenomas per colonoscopy
Tidsram: Periprocedural
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Mean number of adenomas detected per colonoscopy
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Periprocedural
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Presence of diverticulosis
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- Tyson SF, Burton L, McGovern A. The impact of a toolkit on use of standardised measurement tools in stroke rehabilitation. Clin Rehabil. 2015 Sep;29(9):926-34. doi: 10.1177/0269215514562590. Epub 2014 Dec 11.
- Hafeez M, Yuan C, Shahzad K, Aziz B, Iqbal K, Raza S. An empirical evaluation of financial development-carbon footprint nexus in One Belt and Road region. Environ Sci Pollut Res Int. 2019 Aug;26(24):25026-25036. doi: 10.1007/s11356-019-05757-z. Epub 2019 Jun 27.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 november 2022
Primärt slutförande (Faktisk)
24 juni 2025
Avslutad studie (Faktisk)
24 juni 2025
Studieregistreringsdatum
Först inskickad
11 maj 2026
Först inskickad som uppfyllde QC-kriterierna
18 maj 2026
Första postat (Faktisk)
26 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRBNet ID: 1689988
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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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Nej
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