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Antibiotic
All Participants for Pouchitis
Phase 4
Waitlist Available
Led By Edward Barnes, MD, MPH
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial aims to investigate if rifaximin, an antibiotic, can prevent recurrent pouchitis (inflammation of the J-pouch) in patients who have already been treated for an initial episode of
Who is the study for?
This trial is for individuals who have had a colectomy for ulcerative colitis and are experiencing their first episode of pouchitis, which is inflammation of the J-pouch. Participants will be those looking to prevent recurrent inflammation after initial treatment.Check my eligibility
What is being tested?
The study tests if taking Rifaximin (an antibiotic) daily for one year can prevent recurring pouchitis after an initial episode. All participants in this study will receive Rifaximin with the aim to assess its effectiveness and adherence over a year.See study design
What are the potential side effects?
Potential side effects from taking Rifaximin may include digestive issues like nausea or bloating, allergic reactions, headaches, dizziness, and increased risk of infection due to long-term antibiotic use.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants Who Develop Recurrent Pouchitis
Side effects data
From 2014 Phase 4 trial • 222 Patients • NCT0184258119%
Hepatic encephalopathy
17%
Oedema peripheral
16%
Constipation
14%
Nausea
14%
Fatigue
12%
Insomnia
11%
Urinary tract infection
10%
Pruritus generalised
8%
Muscle spasms
7%
Abdominal pain
7%
Decreased appetite
6%
Ascites
6%
Dyspnoea
6%
Headache
5%
Cough
5%
Renal failure acute
5%
Vomiting
5%
Asthenia
5%
Anaemia
5%
Anxiety
4%
Jaundice
4%
Diarrhoea
3%
Abdominal distension
3%
Cellulitis
3%
Depression
2%
Bronchitis
2%
Peritonitis bacterial
2%
Hyperkalaemia
2%
Liver transplant
1%
Hyperglycaemia
1%
Acute respiratory failure
1%
Fluid overload
1%
Non-cardiac chest pain
1%
Gastrointestinal haemorrhage
1%
Haematemesis
1%
Herpes zoster
1%
Cerebrovascular accident
1%
Thrombocytopenia
1%
Pneumococcal bacteraemia
1%
Pneumonia
1%
Sepsis
1%
Septic shock
1%
Craniocerebral injury
1%
Hepatic failure
1%
Hepatitis
1%
Hepatorenal syndrome
1%
Toxic encephalopathy
1%
Subarachnoid haemorrhage
1%
Anxiety disorder
1%
Suicidal ideation
1%
Calculus ureteric
1%
Oliguria
1%
Renal failure
1%
Pleural effusion
1%
Flatulence
1%
Cardiac failure congestive
1%
Haematochezia
1%
Upper gastrointestinal haemorrhage
1%
Chest pain
1%
Systemic inflammatory response syndrome
1%
Chronic hepatic failure
1%
Subdural haematoma
1%
Dehydration
1%
Alcoholic seizure
1%
Hypovolaemic shock
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rifaximin 550 mg BID
Rifaximin 550 mg BID + Lactulose
Trial Design
1Treatment groups
Experimental Treatment
Group I: All ParticipantsExperimental Treatment1 Intervention
550 mg Rifaximin (Xifaxan) twice a day x 365 days
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,504 Previous Clinical Trials
4,187,654 Total Patients Enrolled
2 Trials studying Pouchitis
14 Patients Enrolled for Pouchitis
Bausch Health Americas, Inc.Industry Sponsor
262 Previous Clinical Trials
82,020 Total Patients Enrolled
Edward Barnes, MD, MPHPrincipal InvestigatorUniversity of North Carolina
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks does the intervention pose to individuals involved in the trial?
"Our team at Power has evaluated the safety of All Participants in this Phase 4 trial as a rating of 3, signifying high confidence due to the treatment being officially approved."
Answered by AI
Are patients currently able to participate in this ongoing research study?
"According to clinicaltrials.gov, the current trial is not actively seeking participants. Its posting date was April 1st, 2024, with the most recent update on March 8th, 2024. Despite its inactive status, five other trials are presently open for enrollment."
Answered by AI
Is the clinical trial open to participants who are younger than 35 years old?
"Individuals seeking to participate in this research study must be at least 18 years old and no older than 74."
Answered by AI
Which individuals are considered more suitable candidates for participation in this medical study?
"To be eligible for enrollment in this research study, individuals must have a medical history of pouchitis and fall within the age range of 18 to 74 years. This trial aims to enroll approximately 8 qualified participants."
Answered by AI
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