Lactulose versus sodium phosphate for bowel preparation before colonoscopy
Intestinal Preparation in Colonoscopy: Lactulose vs Sodium Phosphate, a Multicenter, Randomized, Double-Blind Comparative Clinical Trial.
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 |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Civil de Guadalajara Academic / other |
| Locations | 4 sites (Guadalajara, Jalisco and 3 other locations) |
| Trial ID | NCT07060222 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Guadalajara, Jalisco and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.