Lactulose versus sodium phosphate for bowel preparation before colonoscopy
Official title: Intestinal Preparation in Colonoscopy: Lactulose vs Sodium Phosphate, a Multicenter, Randomized, Double-Blind Comparative Clinical Trial.
Run by Hospital Civil de Guadalajara · NCT07060222 · Data updated 2026-11-12
This trial will test whether lactulose or sodium phosphate gives better bowel preparation quality, patient comfort and satisfaction, and causes fewer electrolyte changes for adults scheduled for outpatient colonoscopy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Hospital Civil de Guadalajara Academic / other |
| Locations | 4 sites (Guadalajara, Jalisco and 3 other locations) |
| Status | Recruiting |
| Started | September 20, 2025 |
| Main results expected | November 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT07060222 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults scheduled for outpatient elective colonoscopy who can give informed consent and do not have pregnancy, intestinal obstruction, or known intolerance to lactulose or sodium phosphate.
✕Probably not a fit
Pregnant or breastfeeding women, patients with intestinal obstruction, those needing emergency therapeutic colonoscopy, or anyone with known intolerance to either agent are excluded and would not receive benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double‑blind, multi‑center trial comparing oral lactulose and oral sodium phosphate given as bowel preparation prior to colonoscopy. Adult outpatients scheduled for elective colonoscopy at two hospitals in Guadalajara, Mexico and two hospitals in Panama were enrolled between April 1 and November 30, 2025. Key outcomes include colonoscopy quality (cleanliness and visualization), patient tolerance and satisfaction, and pre/post‑preparation electrolyte changes. Patients with intestinal obstruction, known intolerance to either agent, or who are pregnant or breastfeeding were excluded; data will be analyzed using SPSS.
Why it matters
Potential benefit: If successful, the results could identify a more tolerable and safer bowel preparation that improves colonoscopy quality and patient satisfaction.
How similar studies have gone: Sodium phosphate is a well‑established and effective bowel prep but carries known electrolyte risks, while lactulose has been used less often for bowel cleansing and direct head‑to‑head evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Antigüo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, Mexico Recruiting -
Nuevo Hospital Civil de Guadalajara "Juan I. Menchaca"
Guadalajara, Jalisco, 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, Panama Not yet recruiting
Study contacts
- Study coordinator: Roberto Ulises Cruz Neri U M. C. Roberto Ulises Cruz Neri (Master in Science, Medical Sta, M. C
- Email: robertocruzneri@gmail.com
- Phone: +52 3311946664
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Thirst-Relief Kit vs Placebo to Ease Thirst During Colorectal Prep for Colonoscopy
A thirst-relief kit containing a lemon popsicle is being tested to see if it lowers thirst and improves comfort for adults undergoing hospital bowel preparation for colonoscopy, compared with a placebo.
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Individualized, non-drug prep to improve bowel cleaning for colonoscopy
This trial tests whether an individualized non-pharmacological plan—plus tailored information framing—can improve bowel preparation quality for adults undergoing colonoscopy.
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How GLP-1 and GIP medications affect colonoscopy bowel cleansing
This test will see if taking GLP‑1 or GIP medications affects bowel cleansing for adults getting an outpatient colonoscopy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.