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Assessment of Safety, Quality, and Acceptance of a Bowel Preparation Using a Food Kit With Laxatives

18. maj 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

57

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23249
        • Central Virginia VA Health Care System

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: Use of a standardized meal content (food-kit) the day prior to colonoscopy
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.
Medicin: Polyethylene glycol 3350 - electrolyte solution (GoLYTELY)
Split-dose 4 L PEG-3350 electrolyte lavage solution taken the day before and morning of colonoscopy, combined with 24-hour clear liquid diet.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient acceptance/satisfaction
Tidsramme: Periprocedural
Measure: Scores on a designed survey evaluating acceptance, ease of following instructions and willingness to repeat the preparation.
Periprocedural

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of bowel preparation
Tidsramme: 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.
During colonoscopy (single procedure)
Patient-reported symptoms during bowel preparation
Tidsramme: Periprocedural
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
Tidsramme: Periprocedural
Proportion of subjects with adverse events, defined as any symptom scored as 5 (severely distressing) on the Likert scale.
Periprocedural

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Irrigation and suction time
Tidsramme: Periprocedural
Time spent on irrigation and suction during colonoscopy, measured in minutes
Periprocedural
Colonoscopy withdrawal time
Tidsramme: Periprocedural
Time from cecum to scope removal, measured in minutes
Periprocedural
Total colonoscopy procedure time
Tidsramme: Periprocedural
Total time from scope insertion to removal, measured in minutes
Periprocedural
Cecal intubation rate
Tidsramme: Periprocedural
Proportion of subjects with successful cecal intubation
Periprocedural
Adenoma detection rate
Tidsramme: Periprocedural
Proportion of subjects with at least one adenoma detected
Periprocedural
Adenomas per colonoscopy
Tidsramme: Periprocedural
Mean number of adenomas detected per colonoscopy
Periprocedural
Presence of diverticulosis
Tidsramme: Periprocedural
Proportion of subjects with diverticulosis identified during colonoscopy
Periprocedural
Time to first bowel movement
Tidsramme: Periprocedural
Interval from ingestion of bowel preparation laxative to the first bowel movement
Periprocedural

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Joseph Spataro

Samarbejdspartnere

Happy Colon Foods

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2022

Primær færdiggørelse (Faktiske)

24. juni 2025

Studieafslutning (Faktiske)

24. juni 2025

Datoer for studieregistrering

Først indsendt

11. maj 2026

Først indsendt, der opfyldte QC-kriterier

18. maj 2026

Først opslået (Faktiske)

26. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRBNet ID: 1689988

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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