Fecal Microbiota Transplant vs Standard Treatment for Recurrent Non-Obstructive Cholangitis

NCT07509346 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Hospital U. Puerta de Hierro
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with abnormalities of the biliary tract (the system that connects the liver to the small intestine and allows bile to flow) are prone to the development of strictures, dilations, or other problems that impede bile flow and promote the formation of gallstones. All of this leads to the development of infections in this anatomical region known as cholangitis. These infections typically require the patient to be admitted to the hospital, either to a general ward or even the ICU. These are, therefore, serious infections that threaten the patient's survival. Unfortunately, one-quarter of these patients experience not just one, but multiple infections of this type over an extended period of time. This condition is called acute recurrent cholangitis (ARC). It is important to note that the antibiotics used to treat these repeated infections lead to the selection of more resistant and virulent bacteria that remain in the intestine for months or years and, in turn, promote the recurrence of these infectious episodes. ARC affects a more vulnerable population, which, combined with the proliferation of resistant bacteria, increases the risk of serious complications and a reduced response to available treatments. Replacing these dangerous gut bacteria with bacteria from healthy donors is a strategy that has proven effective in reducing recurrent urinary tract infections. A similar approach has been successful in patients with chronic vaginal infection (vaginosis). This gut microbiota replacement is currently being investigated for a wide range of diseases affecting various sites, with promising results in some cases. There is strong evidence that this strategy may also be effective in patients with recurrent episodes of cholangitis. The procedure is considered very safe and is subject to strict safety measures to prevent risks to the recipient of these bacteria (requirements similar to those used for blood transfusions). If this strategy proves effective, it could reduce patient suffering and even mortality, as well as save money spent on hospital stays and medications, and contribute to reducing antibiotic use and the emergence of bacterial resistance. Even if no significant clinical benefit is demonstrated in this clinical setting, the information obtained will contribute to increasing knowledge about the role of the fecal microbiota, the technical and scientific aspects of fecal microbiota transplantation, and its potential uses. It should be noted that a patient association called ALBI España (Association for the Fight Against Inflammatory Biliary Diseases) has participated in the study's design and strongly supports this research, which could lead to a reduction in mortality among its patients and a reduction in adverse effects and costs associated with hospital admissions and antibiotic use. In summary, the use of FMT in patients with AC could have a significant impact on treatment effectiveness, reducing new episodes of cholangitis. This would improve patients' quality of life-including their physical, emotional, and social well-being-by reducing hospitalizations and associated complications. Another clear benefit would be the reduction in the proliferation of resistant bacteria and a lower use of antibiotics. The use of TMF would increase the autonomy of the National Health System (SNS) by enabling it to develop and manage non-commercial, non-profit therapies with low production costs, which would guarantee equitable access for patients to an effective and safe therapy.

Conditions

Cholangitis Acute; Recurrence

Keywords

FMT for recurrent acute cholangitis

Outcome Measures

Primary Outcomes (1)

• Time to the next episode of acute cholangitis

  24 months

Secondary Outcomes (2)

• Number of recurrent acute cholangitis (RAC) episodes

  24 months

• Intestinal colonization by resistant bacteria

  Three months

Study Arms (2)

Experimental

EXPERIMENTAL

RAC patients will receive

Biological: Fecal Microbial Transplantation

Control

NO INTERVENTION

Interventions

Fecal Microbial Transplantation BIOLOGICAL

Patients with recurrent acute cholangitis will receive FMT

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Oral intolerance or inability to swallow capsules.
• Pregnancy or breastfeeding.
• Any clinically significant disease (other than RAC) such as disseminated malignancy or organ failure resulting in relevant cardiac, hepatic, pulmonary, or neurodegenerative disease with an expected survival of less than one year.
• Inability to understand the study, sign the informed consent, and/or collect stool samples.
• \- RAC due to the presence of choledocholithiasis (any number of stones in the biliary tract) or extrahepatic bile duct stricture that cannot be resolved by surgical or endoscopic treatment. Lack of resolution of extrahepatic biliary obstruction is defined as failure to remove all stones, or a residual diameter in stricture cases of less than 75% of the bile duct diameter above and below the stricture, even after balloon dilation and/or biliary stent placement

Sponsors & Collaborators

• Puerta de Hierro University Hospital: lead

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MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 3, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Individual participant data (IPD) and supporting documents will be available starting 6 months after publication of the primary results and will remain available for up to 5 years.
• Access Criteria: Access to IPD and supporting information will be granted to qualified researchers who provide a methodologically sound research proposal. Requests will be reviewed by the study investigators. Approved researchers will be required to sign a data use agreement. Data will be shared in a de-identified format to protect participant confidentiality and will be provided via secure transfer methods.