Clostridium DifficilePhase 1FMTNCT02134392
Fecal Transplant for Pediatric Patients Who Have Recurrent C-diff Infection
A Phase 1 study testing Fecal Microbiota Transplantation in people with Clostridium Difficile, run by Jonathan Gisser at 1 site in United States.
Trial summary
C-diff infection often causes belly pain and diarrhea and can be very hard to treat with medicine. One of the possible reasons that C-diff infection is hard to treat is because there is too much "bad" bacteria in the colon. Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Clostridium Difficile
- What is being tested?
- Fecal Microbiota Transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Recipient inclusion criteria:
- Documented laboratory-confirmed clostridium difficile infection
- Documentation of ongoing diarrhea at time of recruitment
- Children ≥2 years old, <18 years old; young adults >18 years old, <21 years old
- Undergoing clinically-indicated colonoscopy
- Recurrent c-diff infection (three or more occurrences)
Show all 12Show fewer
- Donor inclusion criteria:
- First-degree relative recommended, but not compulsory
- ≥ 18 years old
- In good health
- No antibiotic use within the last 90 days
- In "low risk" category on modified DHQ (See above)
Who cannot join
- Recipient exclusion criteria
- Severe comorbid condition (at discretion of the principal investigator)
- On immunosuppressive medications (high dose steroids 30 mg/kg of methylprednisolone)
- Severe or fulminant C. difficile colitis
- Toxic appearance
- Signs of hemodynamic instability
Show all 23Show fewer
- Peritoneal signs on physical exam
- Anemia on complete blood count
- electrolyte imbalances on basic metabolic panel
- Considerations for Increased Risk of Adverse Events Should Be Given to patients with decompensated liver cirrhosis, advanced HIV/acquired immune deficiency syndrome, recent bone marrow transplant, or other cause of severe immunodeficiency.
- History of severe anaphylactic shock
- Donor exclusion criteria:
- Abnormal stools
- Abdominal complaints
- History of inflammatory bowel disease or gastrointestinal malignancy
- Symptoms indicative of irritable bowel syndrome or other chronic pain syndromes (e.g. chronic fatigue syndrome, fibromyalgia)
- History of systemic autoimmunity (e.g. multiple sclerosis, connective tissue disease)
- Recent use of potent immunosuppressive medications (calcineurin inhibitors, exogenous glucocorticoids, biological agents, etc..)
- Recent ingestion of a potential allergen (e.g. nuts) where recipient has a known allergy to this (these) agent(s)
- Known communicable disease
- Neurologic, neurodevelopmental or neurodegenerative disorders
- History of malignancy
- Has consumed any foods/medications to which the recipient is allergic within the designated period of time
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
GI Division, Nationwide Children's Hospital
Columbus, Ohio, 43205
Jonathan M. Gisser, M.D., 614-355-2858, jonathan.gisser@nationwidechildrens.org
Jonathan M. Gisser, M.D.
About this study
Official title: Fecal Microbiota Transplantation (FMT) for Recurrent or Refractory C. Difficile Infection (CDI) in Pediatric and Young Adult Patients
C-diff infection often causes belly pain and diarrhea and can be very hard to treat with medicine. One of the possible reasons that C-diff infection is hard to treat is because there is too much "bad" bacteria in the colon. Investigators believe that putting more "good" bacteria into the colon will help fight the "bad" bacteria. We do this by doing a fecal (poop) transplant.
Fecal transplant has been done at other hospitals, but not at Nationwide Children's Hospital. Since our Investigators have not done this before, this study will help us learn the best way to do the transplant. Investigators also believe this transplant might help improve symptoms for patients with C-diff.
Read the detailed description
Visit 1 - screening visit: This visit will take about 1 hour. The study doctor will talk to the patient about C-diff infection and fecal transplant in detail. Investigators will ask you questions about your medical history and health. A complete physical examination will be done. Investigators will order a pregnancy test (for girls who are old enough to become pregnant) and take blood (about 1.5 teaspoons) to make sure you do not have any other illness or infections (other than C-diff.) If the pregnancy test comes back positive on a patient who is younger than age 18, both the patient and parent(s) will be informed. The study doctor will then choose a possible stool donor. The study doctor will ask the donor to fill out a questionnaire about their medical history, past and present diseases, allergies and medications. If this donor seems suitable, blood and stool tests will be performed on the donor.
Before the next visit: Before the fecal transplant is scheduled the study doctor will look at your all of the lab results from you and the donor to make sure it is safe for the fecal transplant to take place. This will take up to two weeks. If the donor is not a suitable donor, another donor will be chosen. Every possible donor will need to sign a consent form and fill out questionnaires. When a suitable donor is found, we will to schedule the fecal transplant.
There are two ways in which the fecal transplant can be given. One is by enema and the other is during a colonoscopy. The study doctor believes that the best way to give the transplant is during a colonoscopy. If you needs to have a colonoscopy done for clinical purposes (in the routine medical care of your C-diff infection), the fecal transplant will happen during that procedure. The doctor will explain the colonoscopy to you in detail and will be given special instructions on how to prepare for the colonoscopy. You will need to sign a separate consent for the colonoscopy. The other way the fecal transplant can be given is by enema. If you are not having a colonoscopy or for some other reason the doctor believes it is better to do so, you will receive the transplant through an enema.
The study doctor will talk with you about stopping medicines that are not allowed during the study. If you are taking antibiotics (such as metronidazole, vancomycin, or rifaximin, nitazoxanide, and fidaxomicin) as a treatment for C-diff, you will be asked to stop these medicines 2 days before the transplant.
Visit 2 - the day of the fecal transplant: This visit will take about 4-6 hours. A pregnancy test will be repeated. If the pregnancy test comes back positive for a patient who is younger than age, both the patient and parent will be informed. The study doctor will ask you and the donor how they are feeling. If either the patient or the donor is not feeling well, the transplant will be reschedule to another day. If both are well, the fecal transplant will proceed.
On the morning of the transplant the donor will be asked to have a bowel movement in a plastic container. The donor will bring this stool sample to the hospital to be processed. This stool sample will be blended into a liquid.
The FMT can be given by either a colonoscopy or enema. The doctor will talk to you about which method will be best for you.
Transplant by colonoscopy: Before the colonoscopy, the study doctor will ask questions about your symptoms and medications. During the colonoscopy, the doctor will squirt one cupful (250 ml) of liquid into the colon using a special colonoscopy tube. The liquid will be made of saline (salt water) and donor stool. The recovery time from the colonoscopy will be the same.
Transplant by enema: The study doctor will ask you questions about your symptoms and medications. The patient's pants and underwear will be removed. A thin slippery tube will be put into the patient's bottom (rectum). The tube will be pushed in as deep as we can without pushing the tube hard. About 1 cupful of liquid will be gently squeezed into the rectum. The liquid will be made of saline (salt water) and donor stool. We will ask the patient to lie down on their left side for 30 minutes and keep the solution in for at least 45 minutes. The patient will then be sent home.
After the transplant: The patient will be called at days 1, 7, 14 and months 1 and 6 to see how they are feeling. The investigator's staff will ask some questions over the phone. The phone call will take about 10 minutes. The patient may also call the study doctor anytime with questions or concerns.
If belly pain or diarrhea continues one month after the transplant, the study doctor will want to repeat a stool test for C-diff. Sometimes the patient is not cured and a second transplant is needed. If a second transplant is needed, the same donor can be used if he/she is willing. The second transplant will be done by enema. The donor would have lab (blood and stool tests) done again to be sure she/he does not have any new infections or illness.
The donor may need to have the lab work done again if the transplant does not happen as scheduled (cancellation, no-show or illness). HIV testing is one of the things we do on potential donors. The HIV testing must be done no more than 14 days before the transplant. The other required lab tests need to be done no more than 30 days before the transplant. The date the transplant is rescheduled to will determine whether or not these tests need to be done again.
- Conditions
- Clostridium Difficile
- Being tested
- Fecal Microbiota Transplantation
- Keywords
- C-diff, Clostridium difficile, Fecal Transplant, FMT, Fecal Microbiota Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationBiological
250 ml of a fecal suspension diluted in saline will be administered via colonoscopy or enema in patients with recurrent c-diff.
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbiota Transplantation | Experimental | 250 ml of a fecal suspension diluted in saline given by colonoscopy or enema. Receives: Biological: Fecal Microbiota Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of C. difficile
The primary objective of the study is to establish the cure rate of C. difficile infection in pediatric patients.
Measured: 6 months post transplant
Secondary outcomes (1)
Adverse events
Follow up phone calls will be made at days 1, 7, 14, and months 1 and 6 to determine whether adverse events have occurred.
Measured: Six months post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startDec 2013
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonathan Gisser
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jonathan Gisser, Nationwide Children's Hospital
- Investigators
- Jonathan M. Gisser, M.D., Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134392
- Sponsor's protocol ID
- IRB12-00691
- Acronym
- FMT
- Status last verified
- Sep 2023
- First submitted
- 7 May 2014
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation (FMT) for Recurrent or Refractory C. Difficile Infection (CDI) in Pediatric and Young Adult Patients
- ClinicalTrials.gov ID
- NCT02134392
- Acronym / sponsor ID
- FMT / IRB12-00691
- Conditions
- Clostridium Difficile
- Keywords
- C-diff, Clostridium difficile, Fecal Transplant, FMT, Fecal Microbiota Transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Jonathan GisserUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 9 May 2014 (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.
C-diff infection often causes belly pain and diarrhea and can be very hard to treat with medicine. One of the possible reasons that C-diff infection is hard to treat is because there is too much "bad" bacteria in the colon. Investigators believe that putting more "good" bacteria into the colon will help fight the "bad" bacteria. We do this by doing a fecal (poop) transplant.
Fecal transplant has been done at other hospitals, but not at Nationwide Children's Hospital. Since our Investigators have not done this before, this study will help us learn the best way to do the transplant. Investigators also believe this transplant might help improve symptoms for patients with C-diff.
Detailed description
Visit 1 - screening visit: This visit will take about 1 hour. The study doctor will talk to the patient about C-diff infection and fecal transplant in detail. Investigators will ask you questions about your medical history and health. A complete physical examination will be done. Investigators will order a pregnancy test (for girls who are old enough to become pregnant) and take blood (about 1.5 teaspoons) to make sure you do not have any other illness or infections (other than C-diff.) If the pregnancy test comes back positive on a patient who is younger than age 18, both the patient and parent(s) will be informed. The study doctor will then choose a possible stool donor. The study doctor will ask the donor to fill out a questionnaire about their medical history, past and present diseases, allergies and medications. If this donor seems suitable, blood and stool tests will be performed on the donor.
Before the next visit: Before the fecal transplant is scheduled the study doctor will look at your all of the lab results from you and the donor to make sure it is safe for the fecal transplant to take place. This will take up to two weeks. If the donor is not a suitable donor, another donor will be chosen. Every possible donor will need to sign a consent form and fill out questionnaires. When a suitable donor is found, we will to schedule the fecal transplant.
There are two ways in which the fecal transplant can be given. One is by enema and the other is during a colonoscopy. The study doctor believes that the best way to give the transplant is during a colonoscopy. If you needs to have a colonoscopy done for clinical purposes (in the routine medical care of your C-diff infection), the fecal transplant will happen during that procedure. The doctor will explain the colonoscopy to you in detail and will be given special instructions on how to prepare for the colonoscopy. You will need to sign a separate consent for the colonoscopy. The other way the fecal transplant can be given is by enema. If you are not having a colonoscopy or for some other reason the doctor believes it is better to do so, you will receive the transplant through an enema.
The study doctor will talk with you about stopping medicines that are not allowed during the study. If you are taking antibiotics (such as metronidazole, vancomycin, or rifaximin, nitazoxanide, and fidaxomicin) as a treatment for C-diff, you will be asked to stop these medicines 2 days before the transplant.
Visit 2 - the day of the fecal transplant: This visit will take about 4-6 hours. A pregnancy test will be repeated. If the pregnancy test comes back positive for a patient who is younger than age, both the patient and parent will be informed. The study doctor will ask you and the donor how they are feeling. If either the patient or the donor is not feeling well, the transplant will be reschedule to another day. If both are well, the fecal transplant will proceed.
On the morning of the transplant the donor will be asked to have a bowel movement in a plastic container. The donor will bring this stool sample to the hospital to be processed. This stool sample will be blended into a liquid.
The FMT can be given by either a colonoscopy or enema. The doctor will talk to you about which method will be best for you.
Transplant by colonoscopy: Before the colonoscopy, the study doctor will ask questions about your symptoms and medications. During the colonoscopy, the doctor will squirt one cupful (250 ml) of liquid into the colon using a special colonoscopy tube. The liquid will be made of saline (salt water) and donor stool. The recovery time from the colonoscopy will be the same.
Transplant by enema: The study doctor will ask you questions about your symptoms and medications. The patient's pants and underwear will be removed. A thin slippery tube will be put into the patient's bottom (rectum). The tube will be pushed in as deep as we can without pushing the tube hard. About 1 cupful of liquid will be gently squeezed into the rectum. The liquid will be made of saline (salt water) and donor stool. We will ask the patient to lie down on their left side for 30 minutes and keep the solution in for at least 45 minutes. The patient will then be sent home.
After the transplant: The patient will be called at days 1, 7, 14 and months 1 and 6 to see how they are feeling. The investigator's staff will ask some questions over the phone. The phone call will take about 10 minutes. The patient may also call the study doctor anytime with questions or concerns.
If belly pain or diarrhea continues one month after the transplant, the study doctor will want to repeat a stool test for C-diff. Sometimes the patient is not cured and a second transplant is needed. If a second transplant is needed, the same donor can be used if he/she is willing. The second transplant will be done by enema. The donor would have lab (blood and stool tests) done again to be sure she/he does not have any new infections or illness.
The donor may need to have the lab work done again if the transplant does not happen as scheduled (cancellation, no-show or illness). HIV testing is one of the things we do on potential donors. The HIV testing must be done no more than 14 days before the transplant. The other required lab tests need to be done no more than 30 days before the transplant. The date the transplant is rescheduled to will determine whether or not these tests need to be done again.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fecal Microbiota Transplantation | Experimental | Biological: Fecal Microbiota Transplantation250 ml of a fecal suspension diluted in saline given by colonoscopy or enema. |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Documented laboratory-confirmed clostridium difficile infection
- Documentation of ongoing diarrhea at time of recruitment
- Children ≥2 years old, <18 years old; young adults >18 years old, <21 years old
- Undergoing clinically-indicated colonoscopy
- Recurrent c-diff infection (three or more occurrences)
Key exclusion criteria (23 listed)
- Recipient exclusion criteria
- Severe comorbid condition (at discretion of the principal investigator)
- On immunosuppressive medications (high dose steroids 30 mg/kg of methylprednisolone)
- Severe or fulminant C. difficile colitis
- Considerations for Increased Risk of Adverse Events Should Be Given to patients with decompensated liver cirrhosis, advanced HIV/acquired immune deficiency syndrome, recent bone marrow transplant, or other cause of severe immunodeficiency.
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 Transplantation250 ml of a fecal suspension diluted in saline will be administered via colonoscopy or enema in patients with recurrent c-diff. | Biological | Fecal Microbiota Transplantation |
Primary outcome
Resolution of C. difficile
Time frame: 6 months post transplant
The primary objective of the study is to establish the cure rate of C. difficile infection in pediatric patients.
1 secondary outcome
Adverse events
Time frame: Six months post transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Clostridium Difficile
Not yet recruitingObservational study
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
RecruitingPhase 3
A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and Older
Clostridoides Difficile Associated Disease
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
Clostridium Difficile, Clostridium Difficile Infections
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. This study is not recruiting at the moment.
Jonathan M. Gisser, M.D. principal investigator
Nationwide Children's Hospital
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 Transplantation in people with Clostridium Difficile, run by Jonathan Gisser 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 12 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 29 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ling Fan, MPH (614-722-3412, ling.fan@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of C. difficile (time frame: 6 months post transplant). 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 29 Sep 2023.