Decolonization of Gram-negative Multi-resistant Organisms (MDRO) with Donor Microbiota (FMT)

NCT04188743 | Recruiting Phase 2

• 2 other identifiers: BC-30342018/0966
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Colonization by Multiple Drug Resistant Organisms (MDROs) during patient hospitalization requires expensive isolation measures and renders the return or transfer to other departments or institutions often impossible. Currently there is no specific treatment available. Patients have to wait for spontaneous clearance which can take months or does not happen at all. The study will test the effect of Fecal Microbiota Transfer (FMT) on gut MDRO colonization. The focus will be on patients with a long-term colonization by Gram-negative bacteria for which isolation is warranted. Participants will be randomized into two treatment groups; allogenic FMT versus autologous FMT. A third group of participants will be monitored but will not receive an FMT. Decolonization rate will be compared one month after treatment. Additionally gut microbial composition will be studied up to one year after FMT.

Conditions

Resistance Bacterial

Keywords

Fecal Microbiota Transplantation; Hospitals, Isolation; Drug Resistance, Multiple, Bacterial; Gram-Negative Bacteria; Gastrointestinal Microbiome

Outcome Measures

Primary Outcomes (1)

• Number of participants with decolonization success/failure

  These participants were screened positive for MDRO's in stool cultures before treatment and monitored at least once per week up to 1 month after treatment. "Decolonization" = 3 consecutive negative cultures in minimal time span of 2 weeks.

  1 month after treatment

Secondary Outcomes (3)

• Side effects

  up to 1 year after treatment

• Treatment effect on microbial community in participants

  up to 1 year after treatment

• Treatment tolerability

  1 month after treatment

Study Arms (3)

Allogenic FMT

EXPERIMENTAL

Participants in the allogenic FMT- group will receive FMT-treatment using healthy donor microbiota supplied by the Ghent Stool Bank. The donor stool (50g) is processed shortly after production and tested intensively. It's frozen at -80°C until administration via naso-duodenal/-jejunal tube (Cortrak).

Biological: Allogenic FMT

Autologous FMT

PLACEBO COMPARATOR

Participants in the autologous FMT- group will receive FMT-treatment using their own microbiota to account for effects due to the treatment itself. Their stool is processed as close to the treatment as feasible. It's processed and frozen at -80°C until administration via naso-duodenal/-jejunal tube (Cortrak).

Biological: Autologous FMT

No intervention

NO INTERVENTION

Participants in the "No intervention"-group will not receive any treatment but will be monitored similarly as the "Allogenic FMT" and "Autologous FMT" groups.

Interventions

Allogenic FMT BIOLOGICAL

Transplantation of fecal microbiota from a donor into a recipient

Also known as: Fecal Microbiota Transplantation with donor stool, Fecal Microbiota Transfer with donor stool

Allogenic FMT

Autologous FMT BIOLOGICAL

Transplantation of autologous fecal microbiota

Also known as: Fecal Microbiota Transplantation with own stool, Fecal Microbiota Transfer with own stool

Autologous FMT

Eligibility Criteria

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

You may qualify if:

• Participants must be at least 18 years of age, and must sign the 'informed consent' form and thus agree with the data collection, sampling and FMT.
• At least 2 consecutive confirmations of MDRO colonization in faeces, which complicate the necessary follow-up and/or therapy for the patient.
• Participants must be able to endure the treatment (evaluated by treating physician).

You may not qualify if:

• Inflammatory bowel disease (Crohn's disease, ulcerative colitis ...)
• Diagnosed hereditary blood disease (Haemophilia, Von Willebrand ...)
• Chronic liver disease
• Active drug use or alcohol abuse / dependence, which according to the researchers' opinion may interfere with the patient's participation in the study
• Simultaneous use of probiotics (except yoghurt)
• Existing immune deficiency (congenital or acquired), or concomitant immunomodulatory treatment (including systemic corticosteroids) in the 12 weeks prior to randomization, nasal or inhaled corticosteroid use is permitted
• Positive pregnancy test (or potentially pregnant)
• Breastfeeding
• Severe food allergy (anaphylaxis, urticarial)
• Antibiotic treatment up to 7 days before FMT, or planned to start within one month after FMT.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Research Foundation Flanders: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Bruno Verhasselt, Prof. Dr.

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno Verhasselt, Prof. Dr.

CONTACT

+3293322226; bruno.verhasselt@uzgent.be

Hannelore Hamerlinck, Master

CONTACT

+3293323637; hannelore.hamerlinck@uzgent.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 150 participants will be randomly allocated to an "intervention" group (100p) and a "no intervention" group (50p). Participants in the "intervention" group will be randomised (double blind) to either fecal microbiota transfer with donor stool (allogenic FMT) or fecal microbiota transfer with own stool (autologous FMT). Participants in the "no intervention" group will be monitored without receiving a fecal microbiota transfer.

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: December 6, 2019
• Study Start: December 18, 2019
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6 months after publication of the primary publication

Locations

BE (1)