Clostridioides Difficile InfectionLTO-CDINCT07569380
Long-Term Outcomes After CDI: FMT Versus Antibiotic-Only Treatment
An observational study of Clostridioides Difficile Infection, run by Umeå University at 1 site in Sweden.
Trial summary
The goal of this observational study is to learn about the long-term effects of fecal microbiota transplantation (FMT) compared with antibiotic-only treatment in adults who were treated for Clostridioides difficile infection (CDI) at Umeå University Hospital between 2016 and 2024. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridioides Difficile Infection
- How many people
- 250 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2026to 1 May 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that within the study period (2016-2024) have received treatment (antibiotic-only or FMT) at Umeå University Hospital.
Who may be able to join
- Adults aged 18 years or older
- Symptomatic, microbiologically verified index CDI from February 1 2016 to December 31 2024
- Having received CDI treatment at Umeå University Hospital (antibiotic-only or FMT)
Who cannot join
- Age below 18 years at follow-up
- Index CDI diagnosis not meeting ESCMID case definition
- Testing positive for another gastrointestinal pathogen (virus/bacteria) that is more plausible to explain the clinical picture at index CDI episode
- Declines participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Umeå University Hospital
Umeå
Johan Rasmuson, MD, PhD, 0046-907850000, johan.rasmuson@umu.se
About this study
Official title: Long-Term Outcomes After Clostridioides Difficile Infection (CDI): Comparative Follow-Up of FMT Versus Antibiotic-Only Treatments (LTO-CDI Cohort)
The goal of this observational study is to learn about the long-term effects of fecal microbiota transplantation (FMT) compared with antibiotic-only treatment in adults who were treated for Clostridioides difficile infection (CDI) at Umeå University Hospital between 2016 and 2024. The main questions it aims to answer are:
- Do patients treated with FMT maintain higher gut bacterial diversity up to 10 years after CDI compared with patients treated with antibiotics only?
- Do donor gut bacteria introduced by FMT persist long-term in the recipient's gut?
- Are there differences in gut metabolism, gut barrier function, and systemic inflammation between FMT-treated and antibiotic-only treated patients at long-term follow-up?
- What are the long-term safety outcomes - including new diseases, hospitalizations, and mortality - in FMT-treated versus antibiotic-only treated patients?
Read more
Researchers will compare patients who received FMT to patients who received antibiotics only to see if FMT leads to lasting differences in gut microbiota, metabolism, immune markers, and clinical outcomes.
Participants will:
- Attend a single study visit at Umeå University Hospital
- Provide samples of blood, stool, urine, and a nasal swab
- Complete two quality-of-life questionnaires
Clinical data will be collected from medical records for all participants.
Read the detailed description
Study design and setting This is a single-center, long-term observational cohort study conducted at the Department of Infectious Diseases, Umeå University Hospital, Sweden. The study enrolls adult patients treated for CDI between February 1, 2016 and December 31, 2024, providing up to 10 years of follow-up from the index CDI episode. Participants are stratified into two groups: FMT-treated and antibiotic-only treated.
CDI case definition Compatible clinical presentation (≥3 loose stools in 24 hours) plus a positive nucleic acid amplification test (LAMP) for C. difficile, consistent with ESCMID diagnostic criteria.
Recruitment Potentially eligible living subjects are identified from departmental diagnosis records and contacted by mail with written study information and an opt-out form. Those who do not return the opt-out form are contacted by telephone and invited to a single study visit for informed consent and enrollment. Deceased individuals are included in safety analyses only, without contact with next of kin.
Biological sampling Blood: EDTA plasma, serum, PBMC isolation Fecal sample Urine sample Nasopharyngeal swab
Archived donor fecal samples and pre- and post-FMT patient samples from the Umeå FMT biobank will be retrieved for longitudinal comparisons.
Observational measures Gut and nasopharyngeal microbiota will be characterized by shotgun metagenomics (strain-level resolution) and 16S rRNA sequencing. Resistome profiling and detection of multidrug-resistant organisms by culture will be performed on fecal samples. Global and targeted metabolomics (short-chain fatty acids, bile acids, redox metabolites) will be performed on feces, urine, and blood. Gut barrier markers in blood will include LPS, LPS-binding protein (LBP), and EndoCAb. Systemic immune profiling will include cytokine panels, soluble immune mediators, antibodies, and transcriptomic profiling of peripheral blood mononuclear cells. The host genome will not be sequenced. Clinical observational measures will include additional CDI after index CDI. Pharmacological treatments and comorbidity at index CDI and follow-up, as well as any antibiotic exposure during follow-up will be collected from the medical records.
- Conditions
- Clostridioides Difficile Infection
- Keywords
- Clostridioides difficile infection, Fecal microbiota transplantation, Gut microbiota, Microbiome engraftment, Intestinal barrier, Antibiotic treatment, Observational study
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic treatment | Participants having received antibiotic-only treatment for previous Clostridioides difficile infection. | |
| Fecal microbiota transplantation (FMT) | Participants having received FMT for previous Clostridioides difficile infection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal microbiota diversity
Intestinal microbiota diversity assessed by metagenomic sequencing of stool samples.
Measured: At follow-up visit 1-10 years after baseline CDI
Secondary outcomes (6)
Donor gut microbiota long-term engraftment
Assessment of donor gut microbiota engraftment in participants stool samples 1-10 years post FMT, performed by metagenomic sequencing.
Measured: At follow-up visit 1-10 years after baseline CDI
Stool short-chain fatty acid concentrations
Stool short-chain fatty acid concentrations assessed using metabolomic methods.
Measured: At follow-up visit 1-10 years after baseline CDI
Circulating markers of intestinal barrier function
Circulating biomarkers related to intestinal barrier function measured in peripheral blood.
Measured: At follow-up visit 1-10 years after baseline CDI
Health-related quality of life
Patient-reported health-related quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five levels (no problems to extreme problems), producing a 5-digit health state profile. Higher index values indicate better health-related quality of life.
Measured: At follow-up visit 1-10 years after baseline CDI
Number of participants with new Clostridioides difficile infection episodes after subsequent antibiotic exposure
Occurrence of new Clostridioides difficile infection episodes following exposure to non-CDI antibiotic treatment during follow-up.
Measured: Within 1-10 years after baseline CDI
Incidence of new comorbidities after FMT versus antibiotic-only treatment
Incidence of new diagnoses (autoimmune, autoinflammatory, neoplastic, and metabolic conditions) in FMT-treated participants compared with antibiotic-only treated participants, ascertained from medical records using ICD-10 diagnostic codes.
Measured: From baseline CDI to 1-10 year follow-up or prior death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridioides Difficile InfectionStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Västerbotten
- Responsible party
- Sponsor
- Investigators
- Johan Rasmuson, MD, PhD, Principal investigator, Umeå University, Department of Clinical Microbiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569380
- Sponsor's protocol ID
- LTO-CDI
- Acronym
- LTO-CDI
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the sensitive nature of the clinical and biological data collected in this observational study.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Outcomes After Clostridioides Difficile Infection (CDI): Comparative Follow-Up of FMT Versus Antibiotic-Only Treatments (LTO-CDI Cohort)
- ClinicalTrials.gov ID
- NCT07569380
- Acronym / sponsor ID
- LTO-CDI / LTO-CDI
- Conditions
- Clostridioides Difficile Infection
- Keywords
- Clostridioides difficile infection, Fecal microbiota transplantation, Gut microbiota, Microbiome engraftment, Intestinal barrier, Antibiotic treatment, Observational study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Region Västerbotten
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 May 2031 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the long-term effects of fecal microbiota transplantation (FMT) compared with antibiotic-only treatment in adults who were treated for Clostridioides difficile infection (CDI) at Umeå University Hospital between 2016 and 2024. The main questions it aims to answer are:
- Do patients treated with FMT maintain higher gut bacterial diversity up to 10 years after CDI compared with patients treated with antibiotics only?
- Do donor gut bacteria introduced by FMT persist long-term in the recipient's gut?
- Are there differences in gut metabolism, gut barrier function, and systemic inflammation between FMT-treated and antibiotic-only treated patients at long-term follow-up?
- What are the long-term safety outcomes - including new diseases, hospitalizations, and mortality - in FMT-treated versus antibiotic-only treated patients?
Researchers will compare patients who received FMT to patients who received antibiotics only to see if FMT leads to lasting differences in gut microbiota, metabolism, immune markers, and clinical outcomes.
Participants will:
- Attend a single study visit at Umeå University Hospital
- Provide samples of blood, stool, urine, and a nasal swab
- Complete two quality-of-life questionnaires
Clinical data will be collected from medical records for all participants.
Detailed description
Study design and setting This is a single-center, long-term observational cohort study conducted at the Department of Infectious Diseases, Umeå University Hospital, Sweden. The study enrolls adult patients treated for CDI between February 1, 2016 and December 31, 2024, providing up to 10 years of follow-up from the index CDI episode. Participants are stratified into two groups: FMT-treated and antibiotic-only treated.
CDI case definition Compatible clinical presentation (≥3 loose stools in 24 hours) plus a positive nucleic acid amplification test (LAMP) for C. difficile, consistent with ESCMID diagnostic criteria.
Recruitment Potentially eligible living subjects are identified from departmental diagnosis records and contacted by mail with written study information and an opt-out form. Those who do not return the opt-out form are contacted by telephone and invited to a single study visit for informed consent and enrollment. Deceased individuals are included in safety analyses only, without contact with next of kin.
Biological sampling Blood: EDTA plasma, serum, PBMC isolation Fecal sample Urine sample Nasopharyngeal swab
Archived donor fecal samples and pre- and post-FMT patient samples from the Umeå FMT biobank will be retrieved for longitudinal comparisons.
Observational measures Gut and nasopharyngeal microbiota will be characterized by shotgun metagenomics (strain-level resolution) and 16S rRNA sequencing. Resistome profiling and detection of multidrug-resistant organisms by culture will be performed on fecal samples. Global and targeted metabolomics (short-chain fatty acids, bile acids, redox metabolites) will be performed on feces, urine, and blood. Gut barrier markers in blood will include LPS, LPS-binding protein (LBP), and EndoCAb. Systemic immune profiling will include cytokine panels, soluble immune mediators, antibodies, and transcriptomic profiling of peripheral blood mononuclear cells. The host genome will not be sequenced. Clinical observational measures will include additional CDI after index CDI. Pharmacological treatments and comorbidity at index CDI and follow-up, as well as any antibiotic exposure during follow-up will be collected from the medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic treatment | – | –Participants having received antibiotic-only treatment for previous Clostridioides difficile infection. |
| Fecal microbiota transplantation (FMT) | – | –Participants having received FMT for previous Clostridioides difficile infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that within the study period (2016-2024) have received treatment (antibiotic-only or FMT) at Umeå University Hospital.
Key inclusion criteria (3 listed)
- Adults aged 18 years or older
- Symptomatic, microbiologically verified index CDI from February 1 2016 to December 31 2024
- Having received CDI treatment at Umeå University Hospital (antibiotic-only or FMT)
Key exclusion criteria (4 listed)
- Age below 18 years at follow-up
- Index CDI diagnosis not meeting ESCMID case definition
- Testing positive for another gastrointestinal pathogen (virus/bacteria) that is more plausible to explain the clinical picture at index CDI episode
- Declines participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intestinal microbiota diversity
Time frame: At follow-up visit 1-10 years after baseline CDI
Intestinal microbiota diversity assessed by metagenomic sequencing of stool samples.
6 secondary outcomes
Donor gut microbiota long-term engraftment
Time frame: At follow-up visit 1-10 years after baseline CDI
Stool short-chain fatty acid concentrations
Time frame: At follow-up visit 1-10 years after baseline CDI
Circulating markers of intestinal barrier function
Time frame: At follow-up visit 1-10 years after baseline CDI
Health-related quality of life
Time frame: At follow-up visit 1-10 years after baseline CDI
Number of participants with new Clostridioides difficile infection episodes after subsequent antibiotic exposure
Time frame: Within 1-10 years after baseline CDI
Incidence of new comorbidities after FMT versus antibiotic-only treatment
Time frame: From baseline CDI to 1-10 year follow-up or prior death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the sensitive nature of the clinical and biological data collected in this observational study.
Related trials for Clostridioides Difficile Infection
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Epidemiology of Clostridioides Difficile Infection (CDI) in Long-term Care Facilities, Assessment of Professional Practices Related to CDI Risk Prevention, and Strategies for Improving Care.
Clostridioides Difficile Infection
Active, not recruitingPhase 2
Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Stem Cell
Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Clostridioides Difficile Infection Recurrence
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
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RecruitingEarly Phase 1
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johan Rasmuson, MD, PhD principal investigator
Umeå University, Department of Clinical Microbiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridioides Difficile Infection, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johan Rasmuson, MD, PhD (0046-907850000, johan.rasmuson@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal microbiota diversity (time frame: At follow-up visit 1-10 years after baseline CDI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.