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Crohn's DiseasePhase 1NCT01847170

Impact of Fecal Biotherapy (FBT) on Microbial Diversity in Patients With Moderate to Severe Inflammatory Bowel Disease

A Phase 1 study testing Fecal Microbial Transplantation in people with Crohn's Disease, run by Beth Israel Deaconess Medical Center 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

The human immune system is usually tolerant of the millions of beneficial commensal bacteria (the microbiome), which colonize the healthy intestinal tract. In contrast, patients with Inflammatory Bowel Disease (IBD) may play host to an imbalanced mix of such intestinal bacteria, which initiates abnormal immune… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn's Disease
What is being tested?
Fecal Microbial Transplantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
May 2013to Nov 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • CD confirmed by biopsy for > 3 months duration
  • Active disease (Harvey-Bradshaw Index > 5
  • Failed standard therapy with; stable doses of 5-ASA >2 weeks; thiopurines >3 months; or is steroid dependent at a dose <20mg/d; (inability to taper off steroid for longer than 1 week)
  • Stable medication regimen for >2 weeks.
  • Age > 18 years old

Who cannot join

  • Diagnosis of indeterminate colitis, or proctitis alone
  • Severe or fulminate colitis
  • Women who are pregnant or nursing
  • Patients who are unable to give informed consent
  • Patients who are unable or unwilling to undergo colonoscopy with moderate sedation (>ASA class II)
  • Patients who have previously undergone FMT
Show all 20Show fewer
  • Patients who have a confirmed malignancy or cancer
  • Patients who are immunocompromised
  • Treatment within last 12 weeks with cyclosporine, tacrolimus, infliximab, adalimumab, certolizumab, natalizumab, thalidomide
  • Antibiotic use within 2-months of start date
  • Participation in a clinical trial in the preceding 30 days or simultaneously during this trial
  • Probiotic use within 30 days of start date
  • Rectal therapy within 14 days of start date
  • Decompensated cirrhosis
  • Congenital or acquired immunodeficiencies
  • Other comorbidities including:
  • Diabetes mellitus, cancer, systemic lupus, must be able to tolerate conscious sedation with colonoscopy
  • Chronic kidney disease as defined by a GFR <60mL/min/1.73m2 44
  • History of rheumatic heart disease, endocarditis, or valvular disease due to risk of bacteremia from colonoscopy
  • Steroid dose >20mg/day

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

The human immune system is usually tolerant of the millions of beneficial commensal bacteria (the microbiome), which colonize the healthy intestinal tract. In contrast, patients with Inflammatory Bowel Disease (IBD) may play host to an imbalanced mix of such intestinal bacteria, which initiates abnormal immune responses in susceptible individuals. The resulting inflammation that occurs in the gastrointestinal tract damages the intestinal lining, leading to symptoms (such as intractable diarrhea, pain or weight loss), heightened cancer risk, other serious complications with substantial morbidity and even death. Current therapies for IBD focus on suppressing the excessive immune response to these bacteria, but have major side effects and do not address any role of the microbiome in disease development.

The investigators hypothesize that there is heightened intraluminal generation of pro-inflammatory factors by luminal "pathogenic" bacteria, such as extracellular nucleotides and purinergic derivatives, which trigger host immune cells. This results in loss of suppressive T regulatory cells with unrestrained immune cell deviation to pathogenic T helper cells that cause inflammatory responses. The investigators' proposal is that correcting the disease-provoking microbiome would beneficially improve gut microbial diversity, alter immune responses elicited in patients by such microbial products of pathogenic bacteria, and ultimately limit and suppress disease activity.

To test the hypothesis, the investigators propose to enroll patients with active Crohn's Disease, and introduce the microbiome of healthy and unrelated individuals to patient's intestinal tract, via fecal biotherapy (FBT) with all applicable safety measures. The investigators propose to comprehensively test the effects of FBT on the host microbiome, determine microbial production of inflammatory nucleotides and derivatives, which the investigators suggest might impact the host immune response and disease activity in patients with IBD.

Conditions
Crohn's Disease
Being tested
Fecal Microbial Transplantation
Medical subject headings
Crohn Disease

What participants receive

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

  • Fecal Microbial TransplantationBiological

    Also called Fecal Transplant, Stool transplant

Study groups in NCT01847170
Study groupRoleWhat they receive
Fecal Microbial TransplantationExperimentalNot described
Receives: Biological: Fecal Microbial Transplantation

What is being measured

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

  1. Safety of FMT in patients with Crohn's disease, as measured by number and nature of adverse events

    Measured: 24 weeks

  2. Recipients' fecal microbial diversity after FMT, when compared to baseline

    Measured: 12 weeks

Secondary outcomes (9)

  1. Recipients' fecal microbial diversity at 4 and 8 weeks after FMT, when compared to baseline

    Measured: 8 weeks

  2. Mean change in Harvey Bradshaw Index (HBI) score

    Measured: 12 weeks

  3. Percentage of patients in clinical remission (those with an HBI score at week 12 <5)

    Measured: 12 weeks

  4. Mean change in Short Inflammatory Bowel Disease Questionnaire (sIBDQ) score

    Measured: 12 weeks

  5. Percentage of patients in endoscopic remission (CDEIS score <3)

    Measured: 12 weeks

  6. Percentage of patients with mucosal healing (CDEIS score <1)

    Measured: 12 weeks

  7. Mean change in CRP levels

    Measured: 12 weeks

  8. Mean change in Crohn's Disease Endoscopic Index of Severity (CDEIS) score

    Measured: 12 weeks

  9. Tolerability score

    Measured: 2 weeks

Timeline

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

  1. First posted6 May 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionNov 2016
  4. Study completionNov 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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01847170
Sponsor's protocol ID
2012P000353
Status last verified
Mar 2017
First submitted
2 May 2013
Last updated
3 Mar 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Vaughn BP, Vatanen T, Allegretti JR, Bai A, Xavier RJ, Korzenik J, Gevers D, Ting A, Robson SC, Moss AC. Increased Intestinal Microbial Diversity Following Fecal Microbiota Transplant for Active Crohn's Disease. Inflamm Bowel Dis. 2016 Sep;22(9):2182-90. doi: 10.1097/MIB.0000000000000893.

    PubMed 27542133

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fecal Microbial Transplantation in people with Crohn's Disease, run by Beth Israel Deaconess Medical Center 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 5 inclusion and 20 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: finished, as of the sponsor's last update on 3 Mar 2017. 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?

Safety of FMT in patients with Crohn's disease, as measured by number and nature of adverse events (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 NCT01847170, which also lists 1 linked publication.

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 3 Mar 2017.

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