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Clinical Trials in Mexico / NCT07060222
Recruiting Phase 4

Intestinal Preparation in Colonoscopy: Lactulose vs Sodium Phosphate.

NCT07060222 · tracked via the Priya Life Science Mexico tracker
Sponsor
Hospital Civil de Guadalajara
Phase
Phase 4
Started
2025-09-20
Last updated
2026-05-05

Condition(s) studied

Bowel Preparation for Colonoscopy

Investigational drug(s) / intervention(s)

Bowel preparation before colonoscopy: Lactulose.Bowel preparation before colonoscopy: Sodium phosphate.

Bowel preparation before colonoscopy: Lactulose.: In this randomized, multicenter, single-blind clinical trial, each patient who meets our inclusion criteria will be assigned a randomized code to be included in one of the two study arms, that is, one of the groups and the assigned bowel preparation for the colonoscopy. The benefits and minimal risks of participation will be explained to them, and they will also be asked to sign an informed consent form so that we can proceed with the colonoscopy and collect all the necessary data for our protocol and variable analysis.

Bowel preparation before colonoscopy: Sodium phosphate.: In this randomized, multicenter, single-blind clinical trial, each patient who meets our inclusion criteria will be assigned a randomized code to be included in one of the two study arms, that is, one of the groups and the assigned bowel preparation for the colonoscopy. The benefits and minimal risks of participation will be explained to them, and they will also be asked to sign an informed consent form so that we can proceed with the colonoscopy and collect all the necessary data for our protocol and variable analysis.

Study summary

To compare intestinal preparation with Lactulose vs. Sodium Phosphate as the better agent for performing high-quality colonoscopies at the Civil Hospital Fray Antonio Alcalde and the Civil Hospital Juan I. Menchaca, both in Guadalajara, Mexico; as well as Hospital Santo Tomás in Panama City, Panama; and Hospital Gustavo Nelson Collado Ríos in Chitré, Panama; during the period from April 1, 2025, to November 30, 2025. The comparison will focus on colonoscopy quality, patient tolerance, satisfaction, and electrolyte changes, using the agents orally as part of the bowel preparation prior to the colonoscopy procedure.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Indication for Scheduled Colonoscopy: Participants must have a valid clinical indication for undergoing a scheduled colonoscopy, such as part of a colorectal cancer screening program, evaluation of gastrointestinal symptoms, or follow-up of previously diagnosed colorectal conditions. * Ability to Provide Informed Consent: Participants must have the physical and mental capacity to understand the nature of the study and voluntarily provide informed consent to participate. Exclusion Criteria: * History of Intestinal Obstruction: Participants with a known or suspected history of intestinal obstruction will be excluded due to the potential risks associated with the administration of bowel preparation agents. * Known Intolerance to Lactulose or Sodium Phosphate: Participants with a known intolerance to lactulose or sodium phosphate will be excluded due to the risk of severe adverse reactions. * Pregnancy and Lactation: Pregnant or breastfeeding women will be excluded due to the lack of safety data on bowel preparation agents in this population. * Interfering Clinical Conditions (Comorbidities): Participants with medical conditions that could interfere with study participation or affect the interpretation of results will be excluded, such as decompensated heart failure, chronic renal or liver disease, and a history of colonic resection.

Primary outcome measure(s)

  • Boston Bowel Preparation Scale — 1 day
    A total score of 6 or more, with no segment below 2.

Trial sites (4)

FacilityCityRegionStatus
Antigüo Hospital Civil de Guadalajara "Fray Antonio Alcalde" Guadalajara Jalisco Recruiting
Nuevo Hospital Civil de Guadalajara "Juan I. Menchaca" Guadalajara Jalisco Not Yet Recruiting
Hospital Gustavo Nelson Collado Ríos Panamá. Panamá Herrera Province Not Yet Recruiting
Hospital Santo Tomas Bella Vista Provincia de Panamá Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07060222 on ClinicalTrials.gov ↗ ← All trials in Mexico