Alcoholic HepatitisNCT02458079
Pentoxyphilline Versus Fecal Microbiota Therapy in Severe Alcoholic Hepatitis
A study testing Pentoxiphylline and Stool microbiota transplantation in people with Alcoholic Hepatitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Treatment for severe alcoholic hepatitis patients not eligible for steroid therapy is a dilemma. Pentoxyfilline has been shown to have no improvement in outcomes as per current studies and liver transplantation is with great risk of recidivism in this difficult to treat cohort of patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcoholic Hepatitis
- What is being tested?
- Pentoxiphylline and Stool microbiota transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2014to 27 Jul 2016
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with a diagnosis of severe alcoholic hepatitis who are steroid ineligible, are non responders or are intolerant
- Severe alcoholic hepatitis defined as Maddrey's Discriminant Function Score (4.6 x (PT test - control))+ S.Bilirubin in mg/dl of more than 32 OR a patient of alcoholic hepatitis (defined as AST:ALT ratio > 2:1) who presents with any grade of hepatic encephalopathy
- Conventional therapy defined as oral steroid therapy (Wysolone ® 40mg once a day for 7 days)
- Failure of therapy defined as a Lille Model Score (http://www.lillemodel.com) of >0.45 at day 8 of steroid therapy OR emergence of complications of steroid therapy or intolerance to steroid protocol or ineligible for steroid therapy.
- Ineligibility for steroid therapy includes - Renal dysfunction, evidence of active sepsis or foci of sepsis, gastro intestinal bleeding and disseminated intravascular coagulation, steroid intolerance, steroid related uncontrolled hyperglycemia which precludes therapy, uncontrolled diabetes mellitus
- A Psychologist will be arranged for recipients who are on Fecal Transplant protocol for psychological support throughout the period of one week, during which the transplant procedure will be performed
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- Healthy persons who are willing for faeces donation have to be a close family member
- The donor will be required to give a written consent for faeces donation
- Once consent is taken, the donor will have to undergo the following screening measures:
- Clostridium difficile toxins A and B by EIA
- Routine bacterial culture for enteric pathogens in stool
- Ova and parasites
- Blood serology for viruses - human immunodeficiency virus [HIV, type 1 and 2] HAV IgM, HBsAg, anti HCV Ab
Who cannot join
- Active gastrointestinal bleeding
- Intracranial bleeding
- Multi-organ failure on mechanical ventilation
- On high inotropic support
- Paralytic ileus
- Pregnancy
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- Sepsis
- Failure to provide consent
- Have abnormal bowel motions
- Have abdominal complaints
- Have symptoms indicative of irritable bowel syndrome
- Have extensive travel history or predisposing factors for potentially transmittable diseases
- Have chronic alcohol intake
- Have history of substance abuse
- Are less than 18 years or more than 60 years of age
- Have HIV and Hepatitis Risk factors
- Have enteric infections
- Have inflammatory bowel disease history
- Have chronic constipation or diarrhea
- Have prior abdominal surgery or GI neoplasms
- Have Metabolic Syndrome
- Have Systemic Autoimmunity
- Have atopic diseases
- Have food and respiratory allergies
- Have any chronic pain syndromes
- Have chronic Neurologic disorders
- Have Neurodevelopmental disorders
- Have had antibiotics for any indication taken within the last 2 months
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Treatment for severe alcoholic hepatitis patients not eligible for steroid therapy is a dilemma. Pentoxyfilline has been shown to have no improvement in outcomes as per current studies and liver transplantation is with great risk of recidivism in this difficult to treat cohort of patients. Dysbiosis forms the central role in severe alcoholic hepatitis patients and modulation of gut microbiota by way of healthy donor fecal transplantation could prove to be a novel way to treating these patients who are ineligible for standard therapy. This study utilizes correction of dysbiosis in severe alcoholic hepatitis and surveys outcomes with the same with respect to survival and liver disease severity scores.
- Conditions
- Alcoholic Hepatitis
- Being tested
- Pentoxiphylline, Stool microbiota transplantation
- Medical subject headings
- Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentoxiphyllineDrug
Stool microbiota transplantationDrug
| Study group | Role | What they receive |
|---|---|---|
| Pentoxiphylline | Experimental | Not described Receives: Drug: Pentoxiphylline |
| Stool Microbiota Transplantation | Active comparator | Not described Receives: Drug: Stool microbiota transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at 3 months
Measured: 3 months
Secondary outcomes (4)
Improvement in SOFA (Sequential Organ Failure Assessment) score at 3 months
Measured: 3 month
Improvement in CTP (Child Turcotte Pugh Score) score at 3 months
Measured: 3 month
Improvement in MELD (Model for End Stage Liver Disease) score at 3 months
Measured: 3 month
Short term mortality in both groups
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study start1 Dec 2014
- Primary completion27 Jul 2016
- Study completion27 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic HepatitisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458079
- Sponsor's protocol ID
- ILBS-AH-02
- Status last verified
- Jul 2017
- First submitted
- 23 May 2015
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pentoxyphilline Versus Fecal Microbiota Therapy in Severe Alcoholic Hepatitis
- ClinicalTrials.gov ID
- NCT02458079
- Acronym / sponsor ID
- ILBS-AH-02
- Conditions
- Alcoholic Hepatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 27 Jul 2016 (actual)
- Study completion
- 27 Jul 2016 (actual)
- First posted
- 29 May 2015 (estimated)
- 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.
Treatment for severe alcoholic hepatitis patients not eligible for steroid therapy is a dilemma. Pentoxyfilline has been shown to have no improvement in outcomes as per current studies and liver transplantation is with great risk of recidivism in this difficult to treat cohort of patients. Dysbiosis forms the central role in severe alcoholic hepatitis patients and modulation of gut microbiota by way of healthy donor fecal transplantation could prove to be a novel way to treating these patients who are ineligible for standard therapy. This study utilizes correction of dysbiosis in severe alcoholic hepatitis and surveys outcomes with the same with respect to survival and liver disease severity scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pentoxiphylline | Experimental | Drug: Pentoxiphylline |
| Stool Microbiota Transplantation | Active comparator | Drug: Stool microbiota transplantation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- All patients with a diagnosis of severe alcoholic hepatitis who are steroid ineligible, are non responders or are intolerant
- Severe alcoholic hepatitis defined as Maddrey's Discriminant Function Score (4.6 x (PT test - control))+ S.Bilirubin in mg/dl of more than 32 OR a patient of alcoholic hepatitis (defined as AST:ALT ratio > 2:1) who presents with any grade of hepatic encephalopathy
- Conventional therapy defined as oral steroid therapy (Wysolone ® 40mg once a day for 7 days)
- Failure of therapy defined as a Lille Model Score (http://www.lillemodel.com) of >0.45 at day 8 of steroid therapy OR emergence of complications of steroid therapy or intolerance to steroid protocol or ineligible for steroid therapy.
- Ineligibility for steroid therapy includes - Renal dysfunction, evidence of active sepsis or foci of sepsis, gastro intestinal bleeding and disseminated intravascular coagulation, steroid intolerance, steroid related uncontrolled hyperglycemia which precludes therapy, uncontrolled diabetes mellitus
Key exclusion criteria (28 listed)
- Active gastrointestinal bleeding
- Intracranial bleeding
- Multi-organ failure on mechanical ventilation
- On high inotropic support
- Paralytic ileus
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 |
|---|---|---|
| Pentoxiphylline | Drug | Pentoxiphylline |
| Stool microbiota transplantation | Drug | Stool Microbiota Transplantation |
Primary outcome
Survival at 3 months
Time frame: 3 months
4 secondary outcomes
Improvement in SOFA (Sequential Organ Failure Assessment) score at 3 months
Time frame: 3 month
Improvement in CTP (Child Turcotte Pugh Score) score at 3 months
Time frame: 3 month
Improvement in MELD (Model for End Stage Liver Disease) score at 3 months
Time frame: 3 month
Short term mortality in both groups
Time frame: 30 days
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 15 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pentoxiphylline and Stool microbiota transplantation in people with Alcoholic Hepatitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 13 inclusion and 28 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 15 Aug 2019. 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 India. 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?
Survival at 3 months (time frame: 3 months). 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 15 Aug 2019.