CholangitisPhase 4NCT07895433
Rifaximin for Prevention of Recurrent Mild-to-moderate Ascending Cholangitis After Biliary-enteric Anastomosis
A Phase 4 study of Cholangitis and Ascending Cholangitis, run by Ruijin Hospital.
Trial summary
This single-center prospective randomized controlled trial plans to recruit 60 adult patients with recurrent ascending cholangitis after biliary-enteric anastomosis. Subjects will be randomized 1:1 to the intervention group or control group. The control group receives standard treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cholangitis, Ascending Cholangitis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have undergone biliary-enteric anastomosis.
- History of mid-to-moderate ascending cholangitis.
- Acute cholangitis prior to enrollment is well-controlled; intravenous antibiotics have been withheld for at least 1 week, with normalized body temperature, white blood cell count and C-reactive protein (CRP).
- Age between 18 and 80 years, inclusive, with no gender restriction.
- The patient or their legal guardian voluntarily signs the informed consent form.
Who cannot join
- Patients with concomitant severe acute cholangitis (TG18 Grade III), septic shock, or those assessed to require emergency biliary drainage (ERCP/PTCD).
- Patients with biliary obstruction confirmed by imaging or endoscopy (such as impacted stones, tumor compression, anastomotic stricture, etc.).
- Patients with known allergy to rifaximin or rifamycin-class agents.
- Patients with severe hepatic dysfunction (Child-Pugh class C) or severe renal insufficiency (eGFR < 30 mL/min/1.73 m²).
- Pregnant or breastfeeding women.
- Patients with other active, uncontrolled systemic infections.
Show all 11Show fewer
- Patients who received continuous rifaximin treatment for more than 7 days within 3 months prior to enrollment.
- Patients with inflammatory bowel disease, celiac disease, short bowel syndrome, or other diseases that substantially alter gut microbiota or drug absorption.
- Patients with unresected primary malignancy, recurrent or metastatic tumor, or those receiving chemotherapy, radiotherapy, or immunotherapy.
- Patients with severe coagulation dysfunction (INR > 2.0 and not correctable).
- Patients with psychiatric disorders, cognitive impairment, or a history of substance abuse that may compromise adherence to the study protocol.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Randomized Controlled Study of Rifaximin for Preventing Recurrence of Retrograde Biliary Tract Infection and Regulating Intestinal Microbiota After Biliary-enteric Anastomosis
This single-center prospective randomized controlled trial plans to recruit 60 adult patients with recurrent ascending cholangitis after biliary-enteric anastomosis. Subjects will be randomized 1:1 to the intervention group or control group. The control group receives standard treatment. The intervention group takes rifaximin tablets together with standard treatment for 3 months. Participants will be followed for 3 months. The primary outcome is the number of recurrent biliary infections. Gut microbiota changes and adverse events will also be evaluated. This open-label study explores whether rifaximin can lower the recurrence risk of cholangitis after biliary-enteric anastomosis.
Read the detailed description
Biliary-enteric anastomosis is associated with a high risk of recurrent ascending cholangitis, which severely impairs patients' quality of life. Current preventive strategies remain limited. This is an open-label, single-center, prospective randomized controlled trial. Patients with recurrent ascending cholangitis after biliary-enteric anastomosis are eligible for screening. The study aims to evaluate the clinical efficacy of rifaximin added to standard therapy for preventing recurrent biliary retrograde infection, as well as its effect on intestinal microbiota. A total of 60 eligible participants will be enrolled and randomly allocated at a 1:1 ratio to the intervention group or control group. Participants in the control group receive standard treatment for recurrent biliary infection prevention. Those in the intervention group receive standard treatment plus oral rifaximin for 3 months. All subjects will be followed for 3 months from the start of intervention. Clinical data, laboratory examinations and fecal samples will be collected during the study period. The primary objective is to compare the recurrence frequency of ascending cholangitis between groups. Secondary assessments include changes in intestinal microbiota and safety profiles. Safety monitoring will be performed throughout the intervention period. Adverse events will be recorded, assessed for severity and relatedness to study treatment. Subjects with intolerable adverse reactions will discontinue study medication and receive appropriate clinical management. This trial does not use placebo. Randomization will be performed using computer-generated random numbers. No independent data monitoring committee is established for this study.
- Conditions
- Cholangitis, Ascending Cholangitis
- Being tested
- Rifaximin combined with standard care, Standard Care (in control arm)
- Keywords
- Biliary-enteric anastomosis, ascending cholangitis, rifaximin, recurrent biliary infection, intestinal microbiota
- Medical subject headings
- Cholangitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifaximin combined with standard careDrug
Oral rifaximin tablets are given for 3 months together with standard preventive treatment for recurrent ascending cholangitis after biliary-enteric anastomosis.
Standard Care (in control arm)Other
Standard preventive management for recurrent ascending cholangitis after biliary-enteric anastomosis, without additional rifaximin.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants receive standard preventive treatment plus oral rifaximin tablets for 3 months Receives: Drug: Rifaximin combined with standard care |
| Control group | Active comparator | Participants receive standard preventive treatment for recurrent ascending cholangitis for 3 months. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of recurrent episodes of retrograde biliary infection within 3 months
Count the number of episodes of recurrent ascending cholangitis within 3 months after starting intervention. The diagnosis of cholangitis is based on modified TG18 criteria
Measured: 3 months from the start of study intervention
Secondary outcomes (1)
Time to first recurrent episode of cholangitis
Time interval from study enrollment to the first recurrent episode of ascending cholangitis.
Measured: Within 3 months after intervention initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholangitisStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned at a 1:1 ratio to two separate parallel groups: intervention group and control group. All participants are followed simultaneously during the study period.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZOU DUOWU, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895433
- Sponsor's protocol ID
- 20261017
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
[1] OBEIDAT Y, SINGH D, ALTARAWNEH S, et al. Ascending Cholangitis Caused by Methicillin-Resistant Staphylococcus aureus Species in a Patient With Cystic Fibrosis [J]. Cureus, 2021, 13(8): e17045. [2] BIRGIN E, TéOULE P, GALATA C, et al. Cholangitis following biliary-enteric anastomosis: A systematic review and meta-analysis [J]. Pancreatology, 2020, 20(4): 736-45. [3] SAKAI H, NOTAKE T, SHIMIZU A, et al. Risk factors for postoperative cholangitis after pancreaticoduodenectomy and evaluation of internal stenting on hepaticojejunostomy: A single-center propensity score-based analysis [J]. J Hepatobiliary Pancreat Sci, 2023, 30(8): 1065-77. [4] ITO Y, ABE Y, KITAGO M, et al. Predictive factors of late cholangitis in patients undergoing pancreaticoduodenectomy [J]. World J Surg Oncol, 2018, 16(1): 19. [5] UEDA H, BAN D, KUDO A, et al. Refractory Long-Term Cholangitis After Pancreaticoduodenectomy: A Retrospective Study [J]. World J Surg, 2017, 41(7): 1882-9. [6] KIHARA Y, YOKOMIZO H. The clinical features of late postoperative cholangitis following pancreaticoduodenectomy brought on by conditions other than cancer recurrence: a single-center retrospective study [J]. BMC Surg, 2022, 22(1): 301. [7] OKABAYASHI T, SHIMA Y, SUMIYOSHI T, et al. Incidence and Risk Factors of Cholangitis after Hepaticojejunostomy [J]. J Gastrointest Surg, 2018, 22(4): 676-83. [8] FUKUOKA H, TOYAMA H, MIZUMOTO T, et al. Risk Factors for Recurrence of Cholangitis After Pancreaticoduodenectomy and Comparison of Stents in Hepaticojejunostomy [J]. World J Surg, 2023, 47(10): 2499-506. [9] BAJAJ J S, HEUMAN D M, SANYAL A J, et al. Modulation of the metabiome by rifaximin in patients with cirrhosis and minimal hepatic encephalopathy [J]. PLoS One, 2013, 8(4): e60042. [10] DOGAN B, FU J, ZHANG S, et al. Rifaximin decreases virulence of Crohn's disease-associated Escherichia coli and epithelial inflammatory responses [J]. J Antibiot (Tokyo), 2018, 71(5): 485-94. [11] JIANG Z D, KE S, DUPONT
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study of Rifaximin for Preventing Recurrence of Retrograde Biliary Tract Infection and Regulating Intestinal Microbiota After Biliary-enteric Anastomosis
- ClinicalTrials.gov ID
- NCT07895433
- Acronym / sponsor ID
- 20261017
- Conditions
- Cholangitis, Ascending Cholangitis
- Keywords
- Biliary-enteric anastomosis, ascending cholangitis, rifaximin, recurrent biliary infection, intestinal microbiota
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Oct 2026 (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.
This single-center prospective randomized controlled trial plans to recruit 60 adult patients with recurrent ascending cholangitis after biliary-enteric anastomosis. Subjects will be randomized 1:1 to the intervention group or control group. The control group receives standard treatment. The intervention group takes rifaximin tablets together with standard treatment for 3 months. Participants will be followed for 3 months. The primary outcome is the number of recurrent biliary infections. Gut microbiota changes and adverse events will also be evaluated. This open-label study explores whether rifaximin can lower the recurrence risk of cholangitis after biliary-enteric anastomosis.
Detailed description
Biliary-enteric anastomosis is associated with a high risk of recurrent ascending cholangitis, which severely impairs patients' quality of life. Current preventive strategies remain limited. This is an open-label, single-center, prospective randomized controlled trial. Patients with recurrent ascending cholangitis after biliary-enteric anastomosis are eligible for screening. The study aims to evaluate the clinical efficacy of rifaximin added to standard therapy for preventing recurrent biliary retrograde infection, as well as its effect on intestinal microbiota. A total of 60 eligible participants will be enrolled and randomly allocated at a 1:1 ratio to the intervention group or control group. Participants in the control group receive standard treatment for recurrent biliary infection prevention. Those in the intervention group receive standard treatment plus oral rifaximin for 3 months. All subjects will be followed for 3 months from the start of intervention. Clinical data, laboratory examinations and fecal samples will be collected during the study period. The primary objective is to compare the recurrence frequency of ascending cholangitis between groups. Secondary assessments include changes in intestinal microbiota and safety profiles. Safety monitoring will be performed throughout the intervention period. Adverse events will be recorded, assessed for severity and relatedness to study treatment. Subjects with intolerable adverse reactions will discontinue study medication and receive appropriate clinical management. This trial does not use placebo. Randomization will be performed using computer-generated random numbers. No independent data monitoring committee is established for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned at a 1:1 ratio to two separate parallel groups: intervention group and control group. All participants are followed simultaneously during the study period.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Rifaximin combined with standard careParticipants receive standard preventive treatment plus oral rifaximin tablets for 3 months |
| Control group | Active comparator | Other: Standard Care (in control arm)Participants receive standard preventive treatment for recurrent ascending cholangitis for 3 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who have undergone biliary-enteric anastomosis.
- History of mid-to-moderate ascending cholangitis.
- Acute cholangitis prior to enrollment is well-controlled; intravenous antibiotics have been withheld for at least 1 week, with normalized body temperature, white blood cell count and C-reactive protein (CRP).
- Age between 18 and 80 years, inclusive, with no gender restriction.
- The patient or their legal guardian voluntarily signs the informed consent form.
Key exclusion criteria (11 listed)
- Patients with concomitant severe acute cholangitis (TG18 Grade III), septic shock, or those assessed to require emergency biliary drainage (ERCP/PTCD).
- Patients with biliary obstruction confirmed by imaging or endoscopy (such as impacted stones, tumor compression, anastomotic stricture, etc.).
- Patients with known allergy to rifaximin or rifamycin-class agents.
- Patients with severe hepatic dysfunction (Child-Pugh class C) or severe renal insufficiency (eGFR < 30 mL/min/1.73 m²).
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| Rifaximin combined with standard careOral rifaximin tablets are given for 3 months together with standard preventive treatment for recurrent ascending cholangitis after biliary-enteric anastomosis. | Drug | Intervention group |
| Standard Care (in control arm)Standard preventive management for recurrent ascending cholangitis after biliary-enteric anastomosis, without additional rifaximin. | Other | Control group |
Primary outcome
Number of recurrent episodes of retrograde biliary infection within 3 months
Time frame: 3 months from the start of study intervention
Count the number of episodes of recurrent ascending cholangitis within 3 months after starting intervention. The diagnosis of cholangitis is based on modified TG18 criteria
1 secondary outcome
Time to first recurrent episode of cholangitis
Time frame: Within 3 months after intervention initiation
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 30 Oct 2026.
- Background[1] OBEIDAT Y, SINGH D, ALTARAWNEH S, et al. Ascending Cholangitis Caused by Methicillin-Resistant Staphylococcus aureus Species in a Patient With Cystic Fibrosis [J]. Cureus, 2021, 13(8): e17045. [2] BIRGIN E, TéOULE P, GALATA C, et al. Cholangitis following biliary-enteric anastomosis: A systematic review and meta-analysis [J]. Pancreatology, 2020, 20(4): 736-45. [3] SAKAI H, NOTAKE T, SHIMIZU A, et al. Risk factors for postoperative cholangitis after pancreaticoduodenectomy and evaluation of internal stenting on hepaticojejunostomy: A single-center propensity score-based analysis [J]. J Hepatobiliary Pancreat Sci, 2023, 30(8): 1065-77. [4] ITO Y, ABE Y, KITAGO M, et al. Predictive factors of late cholangitis in patients undergoing pancreaticoduodenectomy [J]. World J Surg Oncol, 2018, 16(1): 19. [5] UEDA H, BAN D, KUDO A, et al. Refractory Long-Term Cholangitis After Pancreaticoduodenectomy: A Retrospective Study [J]. World J Surg, 2017, 41(7): 1882-9. [6] KIHARA Y, YOKOMIZO H. The clinical features of late postoperative cholangitis following pancreaticoduodenectomy brought on by conditions other than cancer recurrence: a single-center retrospective study [J]. BMC Surg, 2022, 22(1): 301. [7] OKABAYASHI T, SHIMA Y, SUMIYOSHI T, et al. Incidence and Risk Factors of Cholangitis after Hepaticojejunostomy [J]. J Gastrointest Surg, 2018, 22(4): 676-83. [8] FUKUOKA H, TOYAMA H, MIZUMOTO T, et al. Risk Factors for Recurrence of Cholangitis After Pancreaticoduodenectomy and Comparison of Stents in Hepaticojejunostomy [J]. World J Surg, 2023, 47(10): 2499-506. [9] BAJAJ J S, HEUMAN D M, SANYAL A J, et al. Modulation of the metabiome by rifaximin in patients with cirrhosis and minimal hepatic encephalopathy [J]. PLoS One, 2013, 8(4): e60042. [10] DOGAN B, FU J, ZHANG S, et al. Rifaximin decreases virulence of Crohn's disease-associated Escherichia coli and epithelial inflammatory responses [J]. J Antibiot (Tokyo), 2018, 71(5): 485-94. [11] JIANG Z D, KE S, DUPONT
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Cholangitis and Ascending Cholangitis, run by Ruijin Hospital.
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 5 inclusion and 11 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: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 wanqian xu (+8617701635428, xwq13279@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of recurrent episodes of retrograde biliary infection within 3 months (time frame: 3 months from the start of study intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07895433, which also lists 1 linked publication.
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 30 Oct 2026.