FMT in Initial CDI

NCT ID: NCT05257538

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2028-02-28

Brief Summary

The study explores fecal microbiota transfer via retention enema after the first clostridioides difficile episode.

Detailed Description

Clostridioides difficile infections (CDI) remain a significant burden for the patients and the society. According to the National Institute for Health and Welfare (THL), in 2018 there were 4324 CDIs in Finland. C. difficile typically affects patients whose gut microbiota is profoundly damaged by antibiotics. Standard therapy for CDI is antibiotic such as vancomycin. After the standard therapy gut microbiota remains damaged and vulnerable to C difficile reinfection arising from spores that survived the treatment. Early recurrence of CDI is commonly defined as relapse of symptoms and positive testing for fecal C difficile within three months after the previous episode. Recurrent CDI is reported in 10-30% of patients after initial treatment, with recurrence approaching 60% after the third episode.

Fecal microbiota transplantation (FMT) is currently the most effective treatment for recurrent CDI (rCDI), with efficacy of over 90%. Even though FMT is mostly administered endoscopically, it is considered a cost-effective way to treat rCDI patients. FMT is recommended after the second relapse, in other words, after the third antibiotic course for CDI. FMT is most effective in rCDI when administered via colonoscopy. However, colonoscopy is a costly and invasive procedure. The largest study exploring a simple and inexpensive retention enema FMT for rCDI showed a 62% clinical response following a single FMT, and 85% after the second. Baro et al. found that FMT via enema was the most cost-effective initial strategy for the management of second recurrence of community-onset CDI.

In the controlled FMT trials the adverse events have been similar with placebo. Also, the long term safety in up to four years follow up seems to be good. The patients treated with FMT seem to normalize their bowel symptoms faster compared to CDI patients treated with only antibiotics.

FMT reduces antibiotic resistance genes in gut microbiota and therefore has a theoretical potential to reduce infections caused by multi-resistant organisms.

A balanced gut microbiota is important in infection control and essential to normal bowel function. CDI is an indicator of damaged gut microbiota. After a course of antibiotics, the gut microbiota typically becomes less diverse for at least some months. It is not known whether the gut microbiota ever regains its former constitution after such a treatment. We hypothesize that planting a new microbial population soon after antibiotic treatment for CDI reduces the risk of recurrence as well as post-infectious functional bowel disorders.

FMT via colonoscopy is currently recommended after the third CDI (second relapse). Our study explores FMT via inexpensive and minimally invasive retention enema after the first CDI episode.

Conditions

Clostridioides Difficile Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

FMT enema

FMT enema 3-5 days after standard antibiotic treatment

Group Type: ACTIVE_COMPARATOR

FMT

Intervention Type: OTHER

Fecal microbiota transfer from a healthy and tested volunteer

plasebo enema

placebo

Group Type: PLACEBO_COMPARATOR

placebo enema

Intervention Type: OTHER

colored water enema

Interventions

FMT

Fecal microbiota transfer from a healthy and tested volunteer

Intervention Type: OTHER

placebo enema

colored water enema

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• >18 years
• C. difficile PCR in feces positive and clinical symptoms of enteritis.
• Full resolution of diarrhea during antibiotic treatment for C. difficile
• No other ongoing antibacterial treatments.
• No ongoing probiotics.
• Signed informed consent.

Exclusion Criteria

• Pregnant
• Ongoing need for antibacterial treatment
• Life expectancy < 1 year
• Prior C. difficile infection in preceding 3 months
• Unable to provide written consent, due to dementia for example.
• Fecal incontinence i.e. inability to retain enema.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Satakunta Central Hospital

OTHER

Sponsor Role: collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role: collaborator

PaijatHame Central Hospital

OTHER

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Teppo Stenholm

Specialist in gastroenterology and internal medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Turku University hospital

Turku, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Teppo U Stenholm

Role: CONTACT

teppo.stenholm@tyks.fi

023130000

Facility Contacts

Teppo Stenholm

Role: primary

teppo.stenholm@tyks.fi

023130000

Other Identifiers

T123/2021

Identifier Type: -

Identifier Source: org_study_id