A Phase 4 interventional study of Bowel preparation before colonoscopy: Lactulose. and Bowel preparation before colonoscopy: Sodium phosphate. in Bowel Preparation for Colonoscopy, sponsored by Hospital Civil de Guadalajara. Recruiting at 4 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Hospital Civil de Guadalajara · Phase 4, Interventional, and Screening
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.
Randomized Double-Blind Clinical Trial conducted from April 1, 2025, to November 30, 2025, involving patients scheduled for outpatient colonoscopy at the Coloproctology Departments of the Civil Hospital Fray Antonio Alcalde, Civil Hospital Juan I. Menchaca (both in Guadalajara, Mexico), Hospital Santo Tomás in Panama City, Panama, and Hospital Gustavo Nelson Collado Ríos in Chitré, Panama.
Patients undergoing elective or emergency therapeutic colonoscopies, as well as those with certain medical conditions or pregnancy, were excluded from the study. Factors related to bowel preparation were considered, with particular emphasis on the characteristics of the chosen preparation agent, its effects, and findings observed during each patient's colonoscopy. All data were collected in a database, which will be shared via a digital platform using the SPSS statistical package for data analysis, followed by the development of conclusions.
Hospital Civil de Guadalajara is the lead sponsor of 41 studies on the registry; 11 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
Boston Bowel Preparation Scale
A total score of 6 or more, with no segment below 2.
Time frame: 1 day
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.
Adverse gastrointestinal effects due to bowel preparation.
Number of patients experiencing adverse gastrointestinal effects, such as nausea, vomiting, or abdominal distension.
Time frame: Baseline.
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: Baseline
Adenoma detection rate
Quantity and characteristics of adenomas detected during the colonoscopy.
Time frame: Baseline
Plan to share: Undecided — The participants'/patients' data will be recorded only by hospital record and coded ID in the study database, no personal information wil be recorded. If necessary, additional data that may be used in the database will also be considered.
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Nov 2026, 14 months after the start.
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Hospital Civil de Guadalajara