LactuloseNCT05726344
Lactulose vs. Polyethylene Glycol as Bowel Preparation for Colonoscopy in Adults
A study testing Lactulose and Polyethylene Glycol 3350 in people with Lactulose and Polyethylene Glycol, run by Hospital de Clínicas Dr. Manuel Quintela at 1 site in Uruguay.
Trial summary
Colonoscopy is the gold standard in bowel assessment when there is suspicion of colon and rectum pathology. Bowel cleansing is necessary to ensure an optimal visualization of colonic mucosa, allowing this form of detection and removal of polyps. Nowadays international recommendations have multiple bowel preparations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lactulose, Polyethylene Glycol, Bowel Preparation
- What is being tested?
- Lactulose and Polyethylene Glycol 3350
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUruguay
- Study dates
- 10 Feb 2023to 13 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients over 18 years with no bowel surgical procedures
Who cannot join
- Patients willingly deciding not to enter into the study
- Pregnant women
- Patient with colonic resections and/or ileostomies
- Inflammatory bowel disease
- Colonic optimization by prior colonoscopy with poor preparation
- Suspected intestinal occlusion or perforation, intussusception
Show all 19Show fewer
- Patient with melenas
- Oral iron intake in the past 10 days
- Emergency colonoscopy
- Hypersensitivity to any of the components comprised in preparations.
- Diabetics
- Chronic kidney disease in dialysis
- Uncorrected severe dystonias
- Severe psychiatric illness (schizophrenia)
- Low IQ to understand bowel preparation
- Severe constipation (< 1 weekly stool)
- Chronic diarrhea with high rate (≥ 4 daily evenly loose consistency stools for more than 4 weeks)
- Unbalanced heart diseases (ischemic cardiopathology, congestive heart failure, unstable angina, arrhythmias and untreatable high blood pressure)
- Ascites
Trial locations and contacts
1 site in 1 country.
About this study
Colonoscopy is the gold standard in bowel assessment when there is suspicion of colon and rectum pathology. Bowel cleansing is necessary to ensure an optimal visualization of colonic mucosa, allowing this form of detection and removal of polyps. Nowadays international recommendations have multiple bowel preparations. There are differences among them regarding adherence, tolerance and adverse effects. Lactulose (LAC) is widely used in treating constipation. However, there are some randomized clinical assays using LAC as bowel preparation with excellent results according to bowel preparation and tolerance scales. Adherence to bowel preparation significantly affects the result in the endoscopic study.
Safety of polyethylene glycol (PEG) formulations has been validated in several studies, it presents little severe side effects and the advantage of its applicability to patients with several comorbidities (heart, liver and kidney without water deprivation). However, its main disadvantage lies in the need to ingest large amounts of liquid (3-4L), generating intolerance thereto in 15%-45% of patients.
Bowel cleansing preparation with PEG is widely used in clinical practice. Considering that according to international studies reporting better tolerance and adherence with LAC; it is suggested to compare the level of bowel preparation, tolerance and adherence between two groups with LAC and PEG.
- Conditions
- Lactulose, Polyethylene Glycol, Bowel Preparation, Colonoscopy, Bisacodyl
- Being tested
- Lactulose, Polyethylene Glycol 3350
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactuloseDrug
Also called Bisacodyl 20 mg, Water 600 mL
4 tablets of Bisacodyl (5 mg) + 250 mL (162.5g lactulose) of lactulose + 600 mL of water + 2 L of water
Polyethylene Glycol 3350Drug
Also called Bisacodyl 20 mg, Water 3 L
4 tablets of Bisacodyl (5 mg) + 3 bottles Polyethylene Glycol 3350 (Polyethylene glycol 3350 60 g; sodium chloride 1.46 g; potassium chloride 745 mg; Sodium bicarbonate 1.68 g; anhydrous sodium sulfate 5.68 g; pineapple flavoring 483 mg) + 3 L of water
| Study group | Role | What they receive |
|---|---|---|
| Lactulose group | Experimental | Patients participating in the study shall go on with their usual diet prior to colonoscopy. Three days before avoid consuming fruits, vegetables, seeds and cereals. A low residue soft and liquid diet is allowed.
The day before the study, the group receiving lactulose shall take 4 tablets of Bisacodyl (5 mg) the day before the study at 6pm. Then, at 8pm a bottle of 250 mL (162.5g lactulose) of lactulose shall be dissolved in 600 mL of water and all contents (850 mL) shall be taken in 2 hours. At 10pm they have to drink 2 liters still water. Receives: Drug: Lactulose |
| Polyethylene glycol group | Experimental | Patients participating in the study shall go on with their usual diet prior to colonoscopy. Three days before avoid consuming fruits, vegetables, seeds and cereals. A low residue soft and liquid diet is allowed.
The day before the study, the group receiving polyethylene glycol (PEG) should take 4 tablets of Bisacodyl (5 mg) at 4pm. Then, at 6pm, 3 bottles of PEG (Polyethylene glycol 3350 60 g; sodium chloride 1.46 g; potassium chloride 745 mg; Sodium bicarbonate 1.68 g; anhydrous sodium sulfate 5.68 g; pineapple flavoring 483 mg) shall be dissolved in 3 liters of water (1 bottle per liter) and they shall take half the preparation, that is 1 liter and a half in 2 hours. At 10pm they shall take the remaining contents in 2 hours. Receives: Drug: Polyethylene Glycol 3350 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare lactulose vs. Polyethylene Glycol as bowel cleansing preparation for colonoscopy
Compare the level of bowel preparation (by Boston Bowel Preparation Scale) between two groups with lactulose and Polyethylene Glycol.
The minimum and maximum value is 0 and 9, respectively. A proper preparation is consider a Boston Bowel Preparation Scale ≥ 2 scores in each colonic segment. Unsuitable preparation a Boston Bowel Preparation Scale < 2 scores in any of the segments.
Score 0: is considered a segment of unprepared colon with mucosa that cannot be observed given the presence of solid stool which does not disappear after cleansing.
Score 1: part of the colonic mucosa is observed; other areas cannot be suitably assessed given the presence of staining, residual matter and/or opaque liquid.
Score 2: little remaining residual matter and small matter fragments which do not prevent correct visualization of colonic mucosa in said segment.
Score 3: colonic mucosa which can be entirely observed with no residual matter nor small fragments of matter and opaque liquid.
Measured: 6 months
Establish Boston Bowel Preparation Scale inter and intra-observer variability
Two researchers shall review the endoscopic study videos and they shall complete the Boston Bowel Preparation Scale inter-observer questionnaire. Results obtained by the endoscopist in charge of the study and the observers shall be compared so as to establish inter-observer variability. Researchers shall analyze one month later again all colonoscopies recorded thus establishing Boston Bowel Preparation Scale of each endoscopy. Then results previously established shall be compared so as to establish intra-observer variability.
The minimum and maximum value is 0 and 9, respectively. A proper preparation is consider a Boston Bowel Preparation Scale ≥ 2 scores in each colonic segment. Unsuitable preparation a Boston Bowel Preparation Scale < 2 scores in any of the segments.
Measured: 7 months
Secondary outcomes (5)
Assess tolerance between lactulose and Polyethylene Glycol.
To assess tolerance it will be considered: good tolerance those patients with 3 or less symptoms with no major criterion; regular tolerance those patients with 4-5 symptoms, without major criterion and bad tolerance those patients with 6 or more symptoms or 1 or more major criteria.
Measured: 6 months
Assess adherence between lactulose and Polyethylene Glycol.
To assess adherence it shall be assessed if the preparation was completed as well as the will to repeat the same preparation in the future.
Measured: 6 months
Assess side effects between lactulose and Polyethylene Glycol.
To assess side effects of both preparations that will be considered: nausea, vomiting, abdominal pain or bloating, sickness, lipothymia, palpitations, precordial pain, insomnia, anal pain or burning, dry mouth, tinnitus, unpleasant taste.
Measured: 6 months
Establish colonoscopy global adenoma detection rate with lactulose and Polyethylene Glycol.
It correspond to the number of adenomas/adenocarcinomas (histological diagnosis) divided by the total number of colonoscopies performed times 100.
Measured: 6 months
Establish colonoscopy cecal intubation rate in with lactulose and Polyethylene Glycol.
It correspond to the number colonoscopies visualizing ileocecal valve divided by the total number of colonoscopies performed times 100.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start10 Feb 2023
- Primary completion13 Dec 2023
- Study completion13 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LactuloseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An analytical, experimental, prospective study, specifically a triple blind randomized clinical assay (endoscopist, researchers and statistician) in which a bowel preparation is compared for colonoscopy with lactulose vs. Polyethylene Glycol.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clínicas Dr. Manuel Quintela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignacio Moratorio, Hospital de Clínicas Dr. Manuel Quintela
- Investigators
- IGNACIO MORATORIO, MD, Principal investigator, HOSPITAL DE CLINICASMARIA B RUSSO, MD, Principal investigator, HOSPITAL DE CLINICASFLORENCIA RODRIGUEZ, MD, Principal investigator, HOSPITAL DE CLINICAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726344
- Sponsor's protocol ID
- 7477252
- Status last verified
- Dec 2023
- First submitted
- 18 Jan 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, Statistical Analysis Plan and Informed Consent Form
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactulose vs. Polyethylene Glycol as Bowel Preparation for Colonoscopy in Adults
- ClinicalTrials.gov ID
- NCT05726344
- Acronym / sponsor ID
- 7477252
- Conditions
- Lactulose, Polyethylene Glycol, Bowel Preparation, Colonoscopy, Bisacodyl
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hospital de Clínicas Dr. Manuel QuintelaUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 13 Feb 2023 (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.
Colonoscopy is the gold standard in bowel assessment when there is suspicion of colon and rectum pathology. Bowel cleansing is necessary to ensure an optimal visualization of colonic mucosa, allowing this form of detection and removal of polyps. Nowadays international recommendations have multiple bowel preparations. There are differences among them regarding adherence, tolerance and adverse effects. Lactulose (LAC) is widely used in treating constipation. However, there are some randomized clinical assays using LAC as bowel preparation with excellent results according to bowel preparation and tolerance scales. Adherence to bowel preparation significantly affects the result in the endoscopic study.
Safety of polyethylene glycol (PEG) formulations has been validated in several studies, it presents little severe side effects and the advantage of its applicability to patients with several comorbidities (heart, liver and kidney without water deprivation). However, its main disadvantage lies in the need to ingest large amounts of liquid (3-4L), generating intolerance thereto in 15%-45% of patients.
Bowel cleansing preparation with PEG is widely used in clinical practice. Considering that according to international studies reporting better tolerance and adherence with LAC; it is suggested to compare the level of bowel preparation, tolerance and adherence between two groups with LAC and PEG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- An analytical, experimental, prospective study, specifically a triple blind randomized clinical assay (endoscopist, researchers and statistician) in which a bowel preparation is compared for colonoscopy with lactulose vs. Polyethylene Glycol.
| Arm | Type | Receives |
|---|---|---|
| Lactulose group | Experimental | Drug: LactulosePatients participating in the study shall go on with their usual diet prior to colonoscopy. Three days before avoid consuming fruits, vegetables, seeds and cereals. A low residue soft and liquid diet is allowed. The day before the study, the group receiving lactulose shall take 4 tablets of Bisacodyl (5 mg) the day before the study at 6pm. Then, at 8pm a bottle of 250 mL (162.5g lactulose) of lactulose shall be dissolved in 600 mL of water and all contents (850 mL) shall be taken in 2 hours. At 10pm they have to drink 2 liters still water. |
| Polyethylene glycol group | Experimental | Drug: Polyethylene Glycol 3350Patients participating in the study shall go on with their usual diet prior to colonoscopy. Three days before avoid consuming fruits, vegetables, seeds and cereals. A low residue soft and liquid diet is allowed. The day before the study, the group receiving polyethylene glycol (PEG) should take 4 tablets of Bisacodyl (5 mg) at 4pm. Then, at 6pm, 3 bottles of PEG (Polyethylene glycol 3350 60 g; sodium chloride 1.46 g; potassium chloride 745 mg; Sodium bicarbonate 1.68 g; anhydrous sodium sulfate 5.68 g; pineapple flavoring 483 mg) shall be dissolved in 3 liters of water (1 bottle per liter) and they shall take half the preparation, that is 1 liter and a half in 2 hours. At 10pm they shall take the remaining contents in 2 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years with no bowel surgical procedures
Key exclusion criteria (19 listed)
- Patients willingly deciding not to enter into the study
- Pregnant women
- Patient with colonic resections and/or ileostomies
- Inflammatory bowel disease
- Colonic optimization by prior colonoscopy with poor preparation
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 |
|---|---|---|
| LactuloseAlso: Bisacodyl 20 mg, Water 600 mL4 tablets of Bisacodyl (5 mg) + 250 mL (162.5g lactulose) of lactulose + 600 mL of water + 2 L of water | Drug | Lactulose group |
| Polyethylene Glycol 3350Also: Bisacodyl 20 mg, Water 3 L4 tablets of Bisacodyl (5 mg) + 3 bottles Polyethylene Glycol 3350 (Polyethylene glycol 3350 60 g; sodium chloride 1.46 g; potassium chloride 745 mg; Sodium bicarbonate 1.68 g; anhydrous sodium sulfate 5.68 g; pineapple flavoring 483 mg) + 3 L of water | Drug | Polyethylene glycol group |
Primary outcome
Compare lactulose vs. Polyethylene Glycol as bowel cleansing preparation for colonoscopy
Time frame: 6 months
Compare the level of bowel preparation (by Boston Bowel Preparation Scale) between two groups with lactulose and Polyethylene Glycol. The minimum and maximum value is 0 and 9, respectively. A proper preparation is consider a Boston Bowel Preparation Scale ≥ 2 scores in each colonic segment. Unsuitable preparation a Boston Bowel Preparation Scale < 2 scores in any of the segments. Score 0: is considered a segment of unprepared colon with mucosa that cannot be observed given the presence of solid stool which does not disappear after cleansing. Score 1: part of the colonic mucosa is observed; other areas cannot be suitably assessed given the presence of staining, residual matter and/or opaque liquid. Score 2: little remaining residual matter and small matter fragments which do not prevent correct visualization of colonic mucosa in said segment. Score 3: colonic mucosa which can be entirely observed with no residual matter nor small fragments of matter and opaque liquid.
Establish Boston Bowel Preparation Scale inter and intra-observer variability
Time frame: 7 months
Two researchers shall review the endoscopic study videos and they shall complete the Boston Bowel Preparation Scale inter-observer questionnaire. Results obtained by the endoscopist in charge of the study and the observers shall be compared so as to establish inter-observer variability. Researchers shall analyze one month later again all colonoscopies recorded thus establishing Boston Bowel Preparation Scale of each endoscopy. Then results previously established shall be compared so as to establish intra-observer variability. The minimum and maximum value is 0 and 9, respectively. A proper preparation is consider a Boston Bowel Preparation Scale ≥ 2 scores in each colonic segment. Unsuitable preparation a Boston Bowel Preparation Scale < 2 scores in any of the segments.
5 secondary outcomes
Assess tolerance between lactulose and Polyethylene Glycol.
Time frame: 6 months
Assess adherence between lactulose and Polyethylene Glycol.
Time frame: 6 months
Assess side effects between lactulose and Polyethylene Glycol.
Time frame: 6 months
Establish colonoscopy global adenoma detection rate with lactulose and Polyethylene Glycol.
Time frame: 6 months
Establish colonoscopy cecal intubation rate in with lactulose and Polyethylene Glycol.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: Yes. Study protocol, Statistical Analysis Plan and Informed Consent Form
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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. This study is not recruiting at the moment.
IGNACIO MORATORIO, MD principal investigator
HOSPITAL DE CLINICAS
MARIA B RUSSO, MD principal investigator
HOSPITAL DE CLINICAS
FLORENCIA RODRIGUEZ, MD principal investigator
HOSPITAL DE CLINICAS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactulose and Polyethylene Glycol 3350 in people with Lactulose and Polyethylene Glycol, run by Hospital de Clínicas Dr. Manuel Quintela at 1 site in Uruguay.
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 1 inclusion and 19 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: finished, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uruguay. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare lactulose vs. Polyethylene Glycol as bowel cleansing preparation for colonoscopy (time frame: 6 months). The study lists 2 primary outcomes in all. 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 27 Dec 2023.