FMT in Initial CDI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FMT, placebo enema.
- Who it may be relevant to
- Registry conditions: Clostridioides Difficile Infection. Basic parameters: 18 years — 120 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Fecal Microbiota Transplantation in Initial Clostridioides Difficile Enteritis: a Randomized, Placebo-controlled Trial
Overview
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.
Interventions
- Other FMT
Fecal microbiota transfer from a healthy and tested volunteer - Other placebo enema
colored water enema
Primary outcome measures
- clostridioides difficile relapse rate [Time frame: month 3]
Secondary outcome measures (9)
- Resolution of gastrointestinal symptoms [Time frame: month 3 and 1 year]
- composition of fecal microbiota [Time frame: month 3 and 1 year]
- Retention time, i.e. time from FMT to subsequent defecation [Time frame: day 1]
- Fecal microbiota transfer adverse events [Time frame: within 1 year of administration]
- Adherence to FMT [Time frame: From recruitment until FMT administration. Up to 15 days]
- Alterations in mood as measured by total score of BDI [Time frame: month 3 and 1 year]
- Anxiety as measured by total score of GAD-7 [Time frame: month 3 and 1 year]
- Quality of life as measured by 15D instrument [Time frame: month 3 and 1 year]
- clostridioides difficile relapse rate [Time frame: 1 year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Finland · 1 center
- Turku University hospital — Turku
Identifiers
NCT: NCT05257538 · T123/2021