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Not yet recruitingNCT07895433Updated Oct 26, 2026

Rifaximin for Prevention of Recurrent Mild-to-moderate Ascending Cholangitis After Biliary-enteric Anastomosis

A Phase 4 interventional study of Rifaximin combined with standard care and Standard Care (in control arm) in Recurrent Ascending Cholangitis After Biliary-enteric Anastomosis, sponsored by Ruijin Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Ruijin Hospital · Phase 4, Interventional, and Prevention

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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. The intervention group takes rifaximin tablets together with standard treatment for 3 months. We will follow participants for 3 months. The primary outcome is the number of recurrent biliary infections. We will also evaluate gut microbiota changes and adverse events. 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. We will collect clinical data, laboratory examinations and fecal samples 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.

02

Conditions studied

  • Recurrent Ascending Cholangitis After Biliary-enteric Anastomosis

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Keywords

  • Biliary-enteric anastomosis
  • ascending cholangitis
  • rifaximin
  • recurrent biliary infection
  • intestinal microbiota
03

In context

Cholangitis

226 studies on the registry are indexed under Cholangitis; 31 are open to participants now.

This study's planned enrollment of 60 is close to the median of 55 across 149 interventional studies indexed under Cholangitis.

Browse Cholangitis studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 668 studies on the registry; 377 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adult patients who have undergone biliary-enteric anastomosis for any cause.

  2. Patients with recurrent ascending cholangitis meeting the following criteria:

    1. The interval from the first episode to screening enrollment is at least 6 months.
    2. At least 2 episodes of acute cholangitis within any consecutive 3 months.
    3. At least one episode meets the confirmed diagnostic criteria (modified TG18) with imaging evidence such as pneumobilia or biliary wall thickening and enhancement.
    4. The other episode meets clinical diagnostic criteria: body temperature >38.5°C plus right upper quadrant pain/jaundice, serum direct bilirubin/ALP/GGT greater than 2 times upper limit of normal, significant improvement within 72 hours after antibiotic treatment, and other infectious sources excluded.
  3. Subjects are able to understand the study and sign the written informed consent form voluntarily.

Exclusion criteria

Exclusion Criteria:

  1. Complicated with severe acute cholangitis (TG18 Grade III), septic shock, or patients requiring emergency biliary drainage (ERCP/PTCD) upon assessment.
  2. Radiologically or endoscopically confirmed biliary obstruction (such as impacted stones, tumor compression, anastomotic stricture).
  3. Known allergy to rifaximin or rifamycin-class drugs.
  4. Severe hepatic dysfunction (Child-Pugh class C) or severe renal insufficiency (eGFR \< 30 mL/min/1.73m²).
  5. Pregnant or breastfeeding women.
  6. Presence of other active uncontrolled systemic infection.
  7. Continuous use of rifaximin for more than 7 days within 3 months before enrollment.
  8. Diseases that seriously affect intestinal flora or drug absorption, including inflammatory bowel disease, celiac disease, short bowel syndrome.
  9. Primary tumor not radically resected, with recurrence or metastasis, or receiving concurrent chemotherapy/radiotherapy.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Intervention group

    Participants receive standard preventive treatment plus oral rifaximin tablets for 3 months

    Drug: Rifaximin combined with standard care

  • Active comparator
    Control group

    Participants receive standard preventive treatment for recurrent ascending cholangitis for 3 months.

    Other: Standard Care (in control arm)

Interventions

  • DrugRifaximin combined with standard care

    Oral rifaximin tablets are given for 3 months together with standard preventive treatment for recurrent ascending cholangitis after biliary-enteric anastomosis.

  • OtherStandard Care (in control arm)

    Standard preventive management for recurrent ascending cholangitis after biliary-enteric anastomosis, without additional rifaximin.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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.

    Time frame: Within 3 months after intervention initiation

07

Study locations

No study locations are listed for this record.

08

References and documents

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

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07895433
Lead sponsor
Ruijin Hospital
Responsible party
ZOU DUOWU (Chief Physician, Department of Gastroenterology, Ruijin Hospital) — Principal investigator
First posted
Oct 26, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 26, 2026

Study contacts

wanqian xu
Contact
xwq13279@rjh.com.cn
+8617701635428

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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