Clostridium DifficilePhase 1NCT02636517
Fecal Microbiome Transplant
A Phase 1 study testing Fecal Microbiota Transplant in people with Clostridium Difficile and Inflammatory Bowel Disease, run by Judith Kelsen at 1 site in United States.
Trial summary
Fecal Microbiota Transplant (FMT) in pediatric patients with recurrent C. Difficile with or without Inflammatory Bowel Disease (IBD) The aims of this study are to determine the safety and efficacy of FMT treatment in pediatric patients with recurrent or moderate to severe C. Read more about this study
- Who is it for?
- Ages 3 to 21 years
- Conditions the study is for
- Clostridium Difficile, Inflammatory Bowel Disease, Crohn's Disease
- What is being tested?
- Fecal Microbiota Transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Dec 2027
- Phase
- Phase 1
- 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 3 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of Inflammatory Bowel Disease by colonoscopy, radiographic and clinic measures, as per standard protocol.
- Age ≥ 3 years old.
- Recurrent C. difficile or Moderate to Severe C. difficile.
- Satisfactory completion of the medical interview and physical exam conducted by a study team member
- Participants must be between 3 and 21 years of age (inclusive)
- Signed informed consent form, and assent (if applicable)
Who cannot join
- Patients <3 years old
- Patients with other co-morbid intestinal infectious processes
- Recipients with a history of severe (anaphylactic) food allergy
- If female, participants of childbearing potential (females aged 11 and older or those who have already begun menstruating) will be required to have a urine pregnancy test on the day of the FMT procedure. Patients who are pregnant will not be enrolled.
- Patients with severe IBD.
- Ongoing/anticipated antibiotic use for non-CDI indication
Show all 11Show fewer
- Adverse event attributable to a previous FMT
- Patients with allergies to sodium chloride or glycerol, both ingredients Generally Recognized As Safe (GRAS)
- Any other condition for which the treating physician thinks the treatment may pose a health risk
- Predicted death within time period of follow-up
- Patients who are on supraphysiologic doses of corticosteroids
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Fecal Microbiome Transplant in Pediatric C. Difficile
Fecal Microbiota Transplant (FMT) in pediatric patients with recurrent C. Difficile with or without Inflammatory Bowel Disease (IBD)
The aims of this study are to determine the safety and efficacy of FMT treatment in pediatric patients with recurrent or moderate to severe C. Difficile without (through an observational study) and with (through a clinical trial) Inflammatory Bowel Disease and to determine the effect of FMT on the gut microbiota through the use of 454 pyrosequencing before and after transplantation in these patients.
- Being tested
- Fecal Microbiota Transplant
- Keywords
- Fecal Microbiota transplant
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantBiological
Fecal Microbiota transplant via colonoscopy, considered both a biologic and a drug
| Study group | Role | What they receive |
|---|---|---|
| C. Difficile without IBD | Other | Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile Receives: Biological: Fecal Microbiota Transplant |
| C. Difficile with IBD | Other | Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile with Inflammatory Bowel Disease Receives: Biological: Fecal Microbiota Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with a recurrence of C. difficile (CDI)
The hypothesis is that FMT will be an effective therapy for patients with IBD and CDI, resulting in resolution of symptoms as compared to historical controls on antibiotic therapy.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium DifficileStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Judith Kelsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Judith Kelsen, Children's Hospital of Philadelphia
- Investigators
- Judith Kelsen, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636517
- Sponsor's protocol ID
- 13-010531
- Status last verified
- Feb 2026
- First submitted
- 16 Dec 2015
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiome Transplant in Pediatric C. Difficile
- ClinicalTrials.gov ID
- NCT02636517
- Acronym / sponsor ID
- 13-010531
- Keywords
- Fecal Microbiota transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Judith KelsenUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Dec 2015 (estimated)
- 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.
Fecal Microbiota Transplant (FMT) in pediatric patients with recurrent C. Difficile with or without Inflammatory Bowel Disease (IBD)
The aims of this study are to determine the safety and efficacy of FMT treatment in pediatric patients with recurrent or moderate to severe C. Difficile without (through an observational study) and with (through a clinical trial) Inflammatory Bowel Disease and to determine the effect of FMT on the gut microbiota through the use of 454 pyrosequencing before and after transplantation in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C. Difficile without IBD | Other | Biological: Fecal Microbiota TransplantFecal Microbiota transplant in pediatric patients with recurrent C. Difficile |
| C. Difficile with IBD | Other | Biological: Fecal Microbiota TransplantFecal Microbiota transplant in pediatric patients with recurrent C. Difficile with Inflammatory Bowel Disease |
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Diagnosis of Inflammatory Bowel Disease by colonoscopy, radiographic and clinic measures, as per standard protocol.
- Age ≥ 3 years old.
- Recurrent C. difficile or Moderate to Severe C. difficile.
- Satisfactory completion of the medical interview and physical exam conducted by a study team member
- Participants must be between 3 and 21 years of age (inclusive)
Key exclusion criteria (11 listed)
- Patients <3 years old
- Patients with other co-morbid intestinal infectious processes
- Recipients with a history of severe (anaphylactic) food allergy
- If female, participants of childbearing potential (females aged 11 and older or those who have already begun menstruating) will be required to have a urine pregnancy test on the day of the FMT procedure. Patients who are pregnant will not be enrolled.
- Patients with severe IBD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbiota TransplantFecal Microbiota transplant via colonoscopy, considered both a biologic and a drug | Biological | C. Difficile with IBD, C. Difficile without IBD |
Primary outcome
Number of subjects with a recurrence of C. difficile (CDI)
Time frame: 7 days
The hypothesis is that FMT will be an effective therapy for patients with IBD and CDI, resulting in resolution of symptoms as compared to historical controls on antibiotic therapy.
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 15 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Judith Kelsen, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fecal Microbiota Transplant in people with Clostridium Difficile and Inflammatory Bowel Disease, run by Judith Kelsen at 1 site in United States.
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 6 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 15 Apr 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with a recurrence of C. difficile (CDI) (time frame: 7 days). 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 15 Apr 2026.