Intestinal Preparation in Colonoscopy: Lactulose vs Sodium Phosphate.

NCT07060222 | Recruiting Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: 131/25
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Bowel Preparation for Colonoscopy

Keywords

lactulose; Colonoscopy; sodium phosphate; bowel preparation

Outcome Measures

Primary Outcomes (1)

• Boston Bowel Preparation Scale

  A total score of 6 or more, with no segment below 2.

  1 day

Secondary Outcomes (4)

• Hydroelectrolytic changes.

  Two blood drawns: During screening period and baseline visit.

• Adverse gastrointestinal effects due to bowel preparation.

  Baseline.

• Palatability

  Baseline

• Adenoma detection rate

  Baseline

Study Arms (2)

Intestinal preparation using sodium phosphate

ACTIVE COMPARATOR

Patients will be randomized and assigned a bowel preparation on the day they are given their colonoscopy appointment date.

Combination Product: Bowel preparation before colonoscopy: Sodium phosphate.

Bowel preparation with lactulose

ACTIVE COMPARATOR

Patients will be randomized and assigned a bowel preparation on the day they are given their colonoscopy appointment date.

Combination Product: Bowel preparation before colonoscopy: Lactulose.

Interventions

Bowel preparation before colonoscopy: Lactulose. COMBINATION_PRODUCT

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 with lactulose

Bowel preparation before colonoscopy: Sodium phosphate. COMBINATION_PRODUCT

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.

Intestinal preparation using sodium phosphate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Civil de Guadalajara: lead

Study Sites (4)

Antigüo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Jalisco, 44200, Mexico

RECRUITING

Nuevo Hospital Civil de Guadalajara "Juan I. Menchaca"

Guadalajara, Jalisco, 44340, Mexico

NOT YET RECRUITING

Hospital Gustavo Nelson Collado Ríos Panamá.

Panamá, Herrera Province, Panama

NOT YET RECRUITING

Hospital Santo Tomas

Bella Vista, Provincia de Panamá, 37, Panama

NOT YET RECRUITING

Central Study Contacts

Roberto Ulises Cruz Neri U M. C. Roberto Ulises Cruz Neri (Master in Science, Medical Sta, M. C

CONTACT

+52 3311946664; robertocruzneri@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coloproctologist

Model Details: Multicenter single-blind randomized clinical trial study.

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: July 11, 2025
• Study Start: September 20, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

PA (2); ME (2)