Intestinal Preparation in Colonoscopy: Lactulose vs Sodium Phosphate.
ConditionBowel Preparation for Colonoscopy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Civil de Guadalajara
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Bowel preparation before colonoscopy: Lactulose.
Combination productIn 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.
Combination productIn 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Intestinal preparation using sodium phosphateActive comparator 1 intervention
Group B: Bowel preparation with lactuloseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Boston Bowel Preparation Scale
A total score of 6 or more, with no segment below 2.
Time frame
1 daySecondary outcomes
1
Hydroelectrolytic changes.
Number of patients with changes in blood concentrations of sodium, potassium, chloride, creatinine, and urea.
Time frame
Two blood drawns: During screening period and baseline visit.2
Adverse gastrointestinal effects due to bowel preparation.
Number of patients experiencing adverse gastrointestinal effects, such as nausea, vomiting, or abdominal distension.
Time frame
Baseline.3
Palatability
Number of patients experiencing changes in taste sensation during bowel preparation intake and its aftertaste: Sweet, salty, bitter, sour. Scale 1-5: low; 5-10: high.
Time frame
Baseline4
Adenoma detection rate
Quantity and characteristics of adenomas detected during the colonoscopy.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov