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Ulcerative ColitisPhase 1FMTNCT01947101

Fecal Microbiota Transplantation (FMT) for Treatment of Ulcerative Colitis in Children

A Phase 1 study testing Fecal Microbiota Transplant in people with Ulcerative Colitis, run by Baylor College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients diagnosed with ulcerative colitis (UC), a specific type of inflammatory bowel disease, will be invited to take part in this study. The investigators do not know what causes UC. Read more about this study

Who is it for?
Ages 12 to 20 yearsHealthy volunteers can take part
Conditions the study is for
Ulcerative Colitis
What is being tested?
Fecal Microbiota Transplant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
Feb 2014to May 2016
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 12 to 20 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Patient Inclusion Criteria:

  • Patients must have a diagnosis of ulcerative colitis based on clinical symptoms, as well as laboratory and colonoscopic findings, including histopathologic results of the intestinal mucosa.
  • Pediatric Ulcerative Colitis Activity Index (PUCAI) < 35 [mild activity] as assessed within 4 weeks prior to enrollment and clinical symptoms that are at least stable.
  • Patients must be "immunomodulator dependent," i.e., have a history of steroid dependency (lack of clinical remission for over 8 weeks without steroid therapy), and/or being immunomodulator (azathioprine, 6-mercaptopurine, methotrexate, etc.) treated, and/or biologic agent (infliximab, adalimumab, etc.) treated
  • Patients ≥ 12 and < 21 years of age are eligible for this trial.
  • Patients must be willing to be off current UC therapies.
  • Willingness to undergo a surgical consultation prior to FMT treatment.
  • Patients who are not enema trained will be required to undergo enema training prior to the start of FMT treatment.
  • All patients and/or their parents or legally authorized representatives must sign a written informed consent document. Assent, when appropriate, will be obtained according to institutional guidelines.

Patient Exclusion Criteria:

  • Patients who are known to have the following will be excluded:
  1. Decompensated liver cirrhosis (bleeding varices, ascites, encephalopathy or icterus)
  2. Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS)
  3. Bone marrow transplantation within the past 150 days
  4. Other severe immunodeficiency
  • Patients with severe prior allergic reaction to food will be excluded from the protocol.
  • Patients who are pregnant or lactating will be excluded from the protocol.

Donor Inclusion Criteria:

  • ≥ 18 years and < 45 years
  • Willing to provide stool and blood samples for laboratory testing.
  • Body mass index < 30
  • Willing to fill out a detailed health screening questionnaire

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Texas Children's Hospital

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase I Study of Fecal Microbiota Transplantation (FMT) in Immunomodulator Dependent Pediatric Ulcerative Colitis (UC)

Patients diagnosed with ulcerative colitis (UC), a specific type of inflammatory bowel disease, will be invited to take part in this study. The investigators do not know what causes UC. However, the microbes (such as bacteria and viruses), which normally live in our intestines are thought to play an important role in the development of UC. There are many treatment options for UC such as steroids,and other medications that decrease inflammation. However, none of these can cure the disease.

This study aims to treat pediatric UC in an alternative fashion by changing the microbes in the gut by giving the participant's stool specimens from healthy adult individuals. There is some evidence from a few cases of adult UC that this therapy may cure the disease or at least provide long lasting suppression (remission) of the symptoms. The investigators would like to test this therapeutic intervention in children with UC.

The purpose of this study is to (1) examine the microbiome of stool and colon (2) and to determine whether healthy-donated stool enemas can treat pediatric ulcerative colitis. (3) The investigators will also study the effects of the treatment on colonic gene expression.

Read the detailed description

FMT RECIPIENTS:

Participants will be recruited from the patient population treated by the Pediatric Gastroenterology, Hepatology, and Nutrition Section at Baylor College of Medicine/Texas Children's Hospital.

  1. Activities prior to starting FMT therapy:
  2. Participants will be asked to discontinue or taper their current home medications for ulcerative colitis.
  3. Participants will be asked to complete enema training.
  4. The participant and family will be counseled in case emergency surgical and/or intensive care interventions are required.
  5. Survey Completion to assess clinical symptoms.

II. Initiation of FMT Therapy:

  1. Pre-colonoscopy and FMT therapy preparation: One to two days prior to scheduled colonoscopy the study participant will be asked to provide a stool sample. They will also undergo a bowel clean-out with Miralax for colonoscopy preparation. Colonoscopy (endoscopic examination of the large bowel) will be used to deliver the first donor fecal transplant at the beginning of the therapeutic protocol.
  2. FMT treatment and Initial colonoscopy:

Fecal microbiota transplantation is made possible by utilizing a donor (healthy adult) providing their stool sample. The donor's stool will be screened and tested for known disease-causing agents including viruses, bacteria and parasites to prevent spread of disease to the participant.

On the first day of treatment, the participant will undergo a colonoscopy to deliver the filtered donor stool directly into their colon. Additionally, biopsies will be taken during this procedure for routine diagnostic as well as research purposes.

III. Subsequent FMT treatments:

Enemas will be given periodically to complete a total of 1-year therapy.

IV. Follow-up endoscopy and samples:

A similar but more limited procedure (sigmoidoscopy) will be repeated at 14 weeks into the study period. Biopsies will be taken during this procedure for routine diagnostic as well as research purposes.

FMT DONORS:

Potential healthy adult stool donors (between 18 and 45 years of age) will be recruited by the research staff. They will be asked to volunteer for the screening and regularly supply stool samples according to the study protocol.

Being tested
Fecal Microbiota Transplant
Keywords
Stool transplant, Ulcerative Colitis, Fecal transplant, Inflammatory Bowel Disease
Medical subject headings
Colitis, Ulcerative, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fecal Microbiota TransplantBiological

    Also called stool transplant

    Fecal Microbiota Transplant will be endoscopically administered directly into the colon. Consecutive treatments will be given by rectal enema route.

Study groups in NCT01947101
Study groupRoleWhat they receive
Ulcerative ColitisExperimentalFecal Microbiota Transplant
Receives: Biological: Fecal Microbiota Transplant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess safety of FMT treatment by recording the frequency of adverse events.

    To determine the safety and associated toxicities of serial FMTs in pediatric UC following withdrawal from standard therapy.

    Measured: 12 months

Secondary outcomes (1)

  1. Assess efficacy of FMT treatment with the aid of the Pediatric Ulcerative Colitis Activity (PUCAI) Index, a validated measure of clinical disease severity.

    To preliminarily assess the efficacy of FMT in inducing or maintaining clinical remission of UC.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2013 (estimated)
  2. Study startFeb 2014
  3. Primary completionDec 2014
  4. Study completionMay 2016

Resources

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01947101
Sponsor's protocol ID
H-30591
Other IDs
FMT- Ulcerative Colitis
Acronym
FMT
Status last verified
Jun 2016
First submitted
13 Sep 2013
Last updated
14 Jun 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fecal Microbiota Transplant in people with Ulcerative Colitis, run by Baylor College of Medicine 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?

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: finished, as of the sponsor's last update on 14 Jun 2016. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Assess safety of FMT treatment by recording the frequency of adverse events. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01947101.

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 14 Jun 2016.

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