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Inflammatory Bowel Disease (IBD)Phase 1GMTNCT01560819

Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases

A Phase 1 study testing Gut Microbial Transplantation in people with Inflammatory Bowel Disease (IBD), run by Corewell Health West 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

Inflammatory bowel disease (IBD) is a chronic, debilitating, relapsing inflammatory disorder affecting the gastrointestinal tract which does not have a medical cure. IBD consists of 2 different forms: Crohn's Disease (CD) and Ulcerative Colitis (UC). Read more about this study

Who is it for?
Ages 7 to 21 years
Conditions the study is for
Inflammatory Bowel Disease (IBD)
What is being tested?
Gut Microbial Transplantation
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Mar 2012to Jun 2013
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 7 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Participant Inclusion Criteria:

  1. Children ages >7 and ≤21 years of age with established diagnosis of Inflammatory Bowel Disease (IBD) colitis (patient with ulcerative colitis (UC) or patients with crohn's disease (CD) with colonic involvement only)
  2. Have clinical disease (mild to moderate disease: 10≤ Pediatric Ulcerative Colitis Activity Index (PUCAI) <65)
  3. Have stable disease activity and therapy for two months prior to Gut Microbial Transplantation (GMT) procedure.

Participant Exclusion Criteria:

  1. Fulminant colitis
  2. Indication or scheduled for surgery
  3. Pregnancy
  4. Use of probiotic supplements during the study period (subjects who have stopped use of probiotic supplements will be eligible as long as they stop taking it 2 weeks prior to Day 1 of GMT)
  5. anemia (hemoglobin < 6.0 g/dL) in last one month
  6. Graft versus host disease (GVHD)
  7. Severely immunocompromised - defined as
  8. History of opportunistic infection (tuberculosis, Pneumocystis jirovecii or systemic fungal infections) in last one year or
  9. Neutropenia: Absolute neutrophil count (ANC) <500
  10. Major intra-abdominal surgery within 90 days prior to Day 1 of GMT
  11. Administration of any investigational drug within 30 days prior to Day 1 of GMT.
  12. Have received infliximab or other tumor necrosis factor (TNF) inhibitors within 2 months prior to Day 1 of GMT or are expected to receive such therapy within 1 month post final GMT.

Donor Inclusion Criteria

  1. Based on patient's and parents'/guardian's decision
  2. Will be chosen from immediate adult (≥18 years) family members or close friends
  3. Should have negative or normal results on screening tests (as explained in donor exclusion criteria below)

Donor Exclusion Criteria (adopted from guidelines provided by American Association of Blood Bank Donor History Questionnaire and American Gastroenterological Association)

  1. Positive or abnormal screening test to include:
  2. Hepatitis A Immunoglobulin M (IgM) antibody
  3. Hepatitis B antibody panel suggestive of infection (HBc IgM, HBs Ag, HBs Ab)
  4. Hepatitis C antibody Level
  5. Cytomegalovirus (CMV) IgM antibody
  6. Ebstein Barr Virus (EBV) viral capsid antigen (VCA) IgM antibody
  7. Syphilis Immunoglobulin G (IgG) Ab Screen
  8. Human Immune Deficiency Virus (HIV) I \& II enzyme-linked immunosorbent assay (ELISA) screen
  9. Stool i) Fungal smear ii) Stool cultures to exclude Salmonella, Shigella, Escherichia Coli, Campylobacter, Yersinia, Vibrio, Listeria iii) Clostridium difficile toxin assay iv) Ova and parasite screen for Giardia and Cryptosporidium
  10. History of metabolic syndrome or gastric bypass surgery
  11. History of GI conditions: IBD, irritable bowel syndrome, chronic abdominal pain, GI Malignancy, blood in stool or diarrhea in the last 4 weeks before enrollment
  12. Antibiotic or probiotic use within 3 months before enrollment and for the duration of the donation
  13. Positive response on screening questionnaire to any of the following:
  14. History of active malignancy or any cancer within the last 5 years (excluding basal cell carcinoma of the skin)
  15. Family history of Creutzfeld-Jacob disease
  16. Corneal or dural transplant
  17. History of high risk sexual behavior (e.g. sexual contact with HIV/acquired immune deficiency syndrome (AIDS) positive, hepatitis positive partner, men who have sex with men, sex for drugs or money)
  18. History of signs of sexually transmitted infections such as genital ulcerations, anogenital herpes, anogenital warts, cancroids or syphilitic lesions
  19. Use of illicit drugs
  20. Travel within the last 6 months to areas of the world where diarrheal illnesses are endemic
  21. History or signs of immunosuppression i) History of any immunosuppressant medication(s) within the last 6 months or history of opportunistic infection(s) in past 1 year ii) Signs of immunosuppression such as: <!-- -->
  22. Oral thrush
  23. Disseminated lymphadenopathy

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Helen DeVos Children's Hospital of Spectrum Health Hospitals

    Grand Rapids, Michigan, 49503

Other trials in United States

About this study

Inflammatory bowel disease (IBD) is a chronic, debilitating, relapsing inflammatory disorder affecting the gastrointestinal tract which does not have a medical cure. IBD consists of 2 different forms: Crohn's Disease (CD) and Ulcerative Colitis (UC). In the last 2 decades, Gut Microbial Transplantation (GMT), also known as fecal transplantation, has been used as a treatment option for Clostridium difficile colitis and UC. The literature supports strong evidence for the plausibility of using GMT for patients with IBD associated colitis, especially for patients with UC.

This research will be conducted in the Helen DeVos Children's Hospital (HDVCH) Pediatric gastrointestinal outpatient clinic. A pilot study of ten patients will be conducted to evaluate if GMT improves clinical symptoms in patients with IBD. Patients with IBD colitis (UC and CD with colonic involvement only) will be approached for GMT as a treatment option for their disease. Each subject will undergo 5 sessions (1 session/day, and not necessarily on consecutive days) of GMT within a period of 10 days. Post treatment evaluation will be done at their regularly scheduled clinic follow up.

Healthy donors >18 years of age will be chosen by the family, inclusive of immediate family members and friends. Donors will be required to complete a screening questionnaire, provide medical history, and undergo blood and stool tests.

Being tested
Gut Microbial Transplantation
Keywords
ulcerative colitis, gut microbial transplantation
Medical subject headings
Inflammatory Bowel Diseases, Colitis, Ulcerative

What participants receive

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

  • Gut Microbial TransplantationDrug

    Also called GMT

    Each participant received Gut Microbial Transplantation (GMT) as retention enema over a period of 1 hour (60mL enema every 15 minutes) daily for 5 days. Although 240mL of GMT solution was prepared for each participant, the final administered dose was dependent on the subject's comfort and willingness to proceed with the next enema, which was assessed after each enema infusion. Subjects were monitored for 30 minutes after GMT for any immediate adverse events and discharged.

Study groups in NCT01560819
Study groupRoleWhat they receive
Study ParticipantsExperimentalParticipants did not receive any bowel preparation before Gut Microbial Transplantation (GMT). Audio-visual aids were used to help reduce participants' anxiety about GMT.
Receives: Drug: Gut Microbial Transplantation

What is being measured

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

  1. Clinical Response

    Clinical response (i.e. improvement in Pediatric Ulcerative Colitis Activity Index (PUCAI) score by greater than or equal to 15 points from baseline) at 4 weeks following GMT treatment

    Measured: 4 weeks following GMT Treatment

Timeline

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

  1. First posted22 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionDec 2012
  4. Study completionJun 2013

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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01560819
Sponsor's protocol ID
2011-233
Acronym
GMT
Status last verified
May 2023
First submitted
20 Mar 2012
Last updated
2 Jun 2023
Data monitoring committee
Yes

Publications

  • Kunde S, Pham A, Bonczyk S, Crumb T, Duba M, Conrad H Jr, Cloney D, Kugathasan S. Safety, tolerability, and clinical response after fecal transplantation in children and young adults with ulcerative colitis. J Pediatr Gastroenterol Nutr. 2013 Jun;56(6):597-601. doi: 10.1097/MPG.0b013e318292fa0d.

    PubMed 23542823

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gut Microbial Transplantation in people with Inflammatory Bowel Disease (IBD), run by Corewell Health West 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 2 Jun 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?

Yes. Results are posted in the registry (first posted 4 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Clinical Response (time frame: 4 weeks following GMT Treatment). 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 NCT01560819, 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 2 Jun 2023.

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