Bowel Preparation for ColonoscopyPhase 4NCT07060222
Intestinal Preparation in Colonoscopy: Lactulose vs Sodium Phosphate.
A Phase 4 study testing Bowel preparation before colonoscopy: Lactulose. and Bowel preparation before colonoscopy: Sodium phosphate. in people with Bowel Preparation for Colonoscopy, run by Hospital Civil de Guadalajara at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation for Colonoscopy
- What is being tested?
- Bowel preparation before colonoscopy: Lactulose. and Bowel preparation before colonoscopy: Sodium phosphate.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 20 Sep 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Roberto Ulises Cruz Neri U M. C. Roberto Ulises Cruz Neri (Master in Science, Medical Sta, M. C contact
4 sites in 2 countries
Mexico2 sites, 2 recruiting
- Recruiting
Antigüo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, 44200
Roberto U Cruz Neri, M. C., +52 3311946664, robertocruzneri@gmail.com
- Not yet recruiting
Nuevo Hospital Civil de Guadalajara "Juan I. Menchaca"
Guadalajara, Jalisco, 44340
Jesús A Valenzuela Pérez, M. C., +52 3331497976, dr_jvalenzuela@hotmail.com
Panama2 sites, 2 recruiting
- Not yet recruiting
Hospital Santo Tomas
Bella Vista, Provincia de Panamá, 37
Jose I Latorraca, M. C., +507 67098993, ji09mdmsc@gmail.com
- Not yet recruiting
Hospital Gustavo Nelson Collado Ríos Panamá.
Panamá, Herrera Province
José I Latorraca, M. C., +507 67098993, ji09mdmsc@gmail.com
About this study
Official title: Intestinal Preparation in Colonoscopy: Lactulose vs Sodium Phosphate, a Multicenter, Randomized, Double-Blind Comparative Clinical 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.
Read the detailed description
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.
- Conditions
- Bowel Preparation for Colonoscopy
- Being tested
- Bowel preparation before colonoscopy: Lactulose., Bowel preparation before colonoscopy: Sodium phosphate.
- Keywords
- lactulose, Colonoscopy, sodium phosphate, bowel preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: Bowel preparation before colonoscopy: Lactulose. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Bowel Preparation Scale
A total score of 6 or more, with no segment below 2.
Measured: 1 day
Secondary outcomes (4)
Hydroelectrolytic changes.
Number of patients with changes in blood concentrations of sodium, potassium, chloride, creatinine, and urea.
Measured: 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.
Measured: 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.
Measured: Baseline
Adenoma detection rate
Quantity and characteristics of adenomas detected during the colonoscopy.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start20 Sep 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel Preparation for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter single-blind randomized clinical trial study.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Ulises Cruz Neri, Hospital Civil de Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060222
- Sponsor's protocol ID
- 131/25
- Status last verified
- Apr 2026
- First submitted
- 11 Jun 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Preparation in Colonoscopy: Lactulose vs Sodium Phosphate, a Multicenter, Randomized, Double-Blind Comparative Clinical Trial.
- ClinicalTrials.gov ID
- NCT07060222
- Acronym / sponsor ID
- 131/25
- Conditions
- Bowel Preparation for Colonoscopy
- Keywords
- lactulose, Colonoscopy, sodium phosphate, bowel preparation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospital Civil de GuadalajaraUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Multicenter single-blind randomized clinical trial study.
| Arm | Type | Receives |
|---|---|---|
| Intestinal preparation using sodium phosphate | Active comparator | 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. |
| Bowel preparation with lactulose | Active comparator | Combination Product: Bowel preparation before colonoscopy: Lactulose.Patients will be randomized and assigned a bowel preparation on the day they are given their colonoscopy appointment date. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | Bowel preparation with lactulose |
| Bowel preparation before colonoscopy: Sodium phosphate.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. | Combination product | Intestinal preparation using sodium phosphate |
Primary outcome
Boston Bowel Preparation Scale
Time frame: 1 day
A total score of 6 or more, with no segment below 2.
4 secondary outcomes
Hydroelectrolytic changes.
Time frame: Two blood drawns: During screening period and baseline visit.
Adverse gastrointestinal effects due to bowel preparation.
Time frame: Baseline.
Palatability
Time frame: Baseline
Adenoma detection rate
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roberto Ulises Cruz Neri U M. C. Roberto Ulises Cruz Neri (Master in Science, Medical Sta, M. C contact
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bowel preparation before colonoscopy: Lactulose. and Bowel preparation before colonoscopy: Sodium phosphate. in people with Bowel Preparation for Colonoscopy, run by Hospital Civil de Guadalajara at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Mexico, Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto Ulises Cruz Neri U M. C. Roberto Ulises Cruz Neri (Master in Science, Medical Sta, M. C (+52 3311946664, robertocruzneri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Bowel Preparation Scale (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.