Fecal Transplant for Pediatric Patients Who Have Recurrent C-diff Infection

  • STATUS
    Recruiting
  • End date
    Jan 25, 2022
  • participants needed
    15
  • sponsor
    Jonathan Gisser
Updated on 25 January 2021

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. 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.

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.

Details
Condition Clostridium difficile
Treatment Fecal Microbiota Transplantation
Clinical Study IdentifierNCT02134392
SponsorJonathan Gisser
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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)
Donor inclusion criteria
First-degree relative recommended, but not compulsory
years old
In good health
No antibiotic use within the last 90 days
In "low risk" category on modified DHQ (See above)

Exclusion Criteria

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
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note