Hepatic EncephalopathyPhase 4NCT03100513
PEG (Polyethylene Glycol)Versus Lactulose For Treatment Of Overt Hepatic Encephalopathy
A Phase 4 study testing Lactulose and Polyethylene Glycol in people with Hepatic Encephalopathy, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
The current standard of care for patients with HE includes non-absorbable disaccharides(lactulose);The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose.The exact mode of action by lactulose is thought to be the conversion to lactic acid and acetic acid by colonic bacteria resulting in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatic Encephalopathy
- What is being tested?
- Lactulose and Polyethylene Glycol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Mar 2017to Dec 2019
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult Patients with Overt Hepatic Encephalopathy.
Who cannot join
- Patients with active GIT bleeding.
- Patients with history of bowel obstruction, perforation.
- Patients with history of allergy to PEG.
- Treatment with rifaximin or neomycin in the previous 7 days.
- Patients with major psychiatric illness.
- Patients receiving benzodiazepines and narcotics.
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- Patients with compromised renal.
- Patients receiving medications highly bound to plasma proteins eg. Warfarin.
- Pregnant or lactating women.
- Fulminant hepatic failure.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tropical medicine dept.-Tanta university hospital
Cairo
Sherief Abd-Elsalam, Sherif_tropical@yahoo.com
About this study
Official title: Randomized Trial Comparing The Efficacy of PEG (Polyethylene Glycol) Versus Lactulose For Treatment Of Overt Hepatic Encephalopathy
The current standard of care for patients with HE includes non-absorbable disaccharides(lactulose);The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose.The exact mode of action by lactulose is thought to be the conversion to lactic acid and acetic acid by colonic bacteria resulting in acidification of the gut lumen. This favors conversion of ammonia (NH3) to ammonium (NH4+), which is relatively membrane impermeable; therefore, less ammonia is absorbed by the colon. Gut acidification inhibits ammoniagenic coliform bacteria, leading to increased levels of nonammoniagenic lactobacilli. Nonabsorbable disaccharides also work as a cathartic, clearing the gut of ammonia before it can be absorbed.
Read the detailed description
Polyethylene glycol electrolyte solution (PEG) is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. It is used safely to clean the bowel before colonoscopy.
- Conditions
- Hepatic Encephalopathy
- Being tested
- Lactulose, Polyethylene Glycol
- Medical subject headings
- Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactuloseDrug
Also called Duphlac, lactulose
(lactulose) (20 to 30 g administered orally or by nasogastric tube (3 or more doses within 24 hours) or 200 g by rectal tube if oral intake was not possible or inadequate
Polyethylene GlycolDrug
PEG as single dose of (3sachets if patient <75Kg over 3 hours or 4 sachets if patient >75Kg over 4 hours) dministered orally or via a nasogastric tube (each sachet 64g/25Kg must be dissolved in one liter of water).
| Study group | Role | What they receive |
|---|---|---|
| Lactulose | Active comparator | (20 to 30 g administered orally or by nasogastric tube (3 or more doses within 24 hours) or 200 g by rectal tube if oral intake was not possible or inadequate. Receives: Drug: Lactulose |
| Polyeyhylene Glychol | Active comparator | Polyethylene Glycol 3sachets if patient <75Kg over 3 hours or 4 sachets if patient >75Kg over 4 hours dministered orally or via a nasogastric tube (each sachet 64g/25Kg must be dissolved in one liter of water) Receives: Drug: Polyethylene Glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 or more in HE grade improvement at 24 hours
HE grade improvement at 24 hours
Measured: 24 hours
Secondary outcomes (2)
Time to HE resolution
Time to Hepatic encephalopathy resolution
Measured: 2 weeks
Overall length of stay
Overall length of stay
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start11 Mar 2017
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Hanan Soliman, MD, Principal investigator, Tanta University Faculty of MedicineAmany Abd El-Rahim Abdin, MD, Study director, Tanta university Faculty of PharmacySamah Mosaad Soliman, MD, Study director, Tanta University Faculty of MedicineHala Hany Shehata, Msc, Study chair, Tanta University Faculty of MedicineSherief Abd-Elsalam, MD, Study chair, Tanta University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100513
- Sponsor's protocol ID
- Hanan Soliman
- Status last verified
- Apr 2017
- First submitted
- 24 Mar 2017
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing The Efficacy of PEG (Polyethylene Glycol) Versus Lactulose For Treatment Of Overt Hepatic Encephalopathy
- ClinicalTrials.gov ID
- NCT03100513
- Acronym / sponsor ID
- Hanan Soliman
- Conditions
- Hepatic Encephalopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- 11 Mar 2017 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 4 Apr 2017 (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.
The current standard of care for patients with HE includes non-absorbable disaccharides(lactulose);The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose.The exact mode of action by lactulose is thought to be the conversion to lactic acid and acetic acid by colonic bacteria resulting in acidification of the gut lumen. This favors conversion of ammonia (NH3) to ammonium (NH4+), which is relatively membrane impermeable; therefore, less ammonia is absorbed by the colon. Gut acidification inhibits ammoniagenic coliform bacteria, leading to increased levels of nonammoniagenic lactobacilli. Nonabsorbable disaccharides also work as a cathartic, clearing the gut of ammonia before it can be absorbed.
Detailed description
Polyethylene glycol electrolyte solution (PEG) is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. It is used safely to clean the bowel before colonoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactulose | Active comparator | Drug: Lactulose(20 to 30 g administered orally or by nasogastric tube (3 or more doses within 24 hours) or 200 g by rectal tube if oral intake was not possible or inadequate. |
| Polyeyhylene Glychol | Active comparator | Drug: Polyethylene GlycolPolyethylene Glycol 3sachets if patient <75Kg over 3 hours or 4 sachets if patient >75Kg over 4 hours dministered orally or via a nasogastric tube (each sachet 64g/25Kg must be dissolved in one liter of water) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adult Patients with Overt Hepatic Encephalopathy.
Key exclusion criteria (10 listed)
- Patients with active GIT bleeding.
- Patients with history of bowel obstruction, perforation.
- Patients with history of allergy to PEG.
- Treatment with rifaximin or neomycin in the previous 7 days.
- Patients with major psychiatric illness.
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: Duphlac, lactulose(lactulose) (20 to 30 g administered orally or by nasogastric tube (3 or more doses within 24 hours) or 200 g by rectal tube if oral intake was not possible or inadequate | Drug | Lactulose |
| Polyethylene GlycolPEG as single dose of (3sachets if patient <75Kg over 3 hours or 4 sachets if patient >75Kg over 4 hours) dministered orally or via a nasogastric tube (each sachet 64g/25Kg must be dissolved in one liter of water). | Drug | Polyeyhylene Glychol |
Primary outcome
1 or more in HE grade improvement at 24 hours
Time frame: 24 hours
HE grade improvement at 24 hours
2 secondary outcomes
Time to HE resolution
Time frame: 2 weeks
Overall length of stay
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
Hanan Soliman, MD principal investigator
Tanta University Faculty of Medicine
Amany Abd El-Rahim Abdin, MD study director
Tanta university Faculty of Pharmacy
Samah Mosaad Soliman, MD study director
Tanta University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lactulose and Polyethylene Glycol in people with Hepatic Encephalopathy, run by Sherief Abd-Elsalam at 1 site in Egypt.
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 10 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: status not confirmed, as of the sponsor's last update on 27 Apr 2017. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, MD (00201095159522, Sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 or more in HE grade improvement at 24 hours (time frame: 24 hours). 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 Apr 2017.