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Microbiome Therapy

Fecal Microbiota Transplantation for Crohn's Disease

Phase 1
Waitlist Available
Led By Alka Goyal, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up microbiome will be measures at baseline, 1.5, 3.5 and 6 months (+/- 2 weeks) after transplantation
Awards & highlights

Study Summary

This trial is testing whether fecal transplants can help treat Crohn's disease in children and young adults. The primary goal is to assess safety, and the secondary goals are to assess efficacy and understand how the transplants work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~calprotectin will be measures at baseline, 1.5 month and 6 months (+/- 2 weeks) after transplantation
This trial's timeline: 3 weeks for screening, Varies for treatment, and calprotectin will be measures at baseline, 1.5 month and 6 months (+/- 2 weeks) after transplantation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety as assessed by Adverse events
Secondary outcome measures
Efficacy as assessed by PCDAI (Pediatric crohn's disease Activity Index)analysis
Efficacy as assessed by Physician Global Assessment (PGA)
Response as assessed by fecal calprotectin
+1 more

Side effects data

From 2020 Phase 1 & 2 trial • 50 Patients • NCT03106844
44%
Diarrhea
26%
Abdominal Pain
16%
Rectal Bleeding
12%
Constiption
10%
Fever
10%
Nausea
6%
Vomiting
6%
Fatigue
4%
Heart Burn
4%
Chills
4%
Migraine
4%
Yeast Infection
2%
Anemia
2%
IBD Flare
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Fecal Microbiota Follow up EnemasExperimental Treatment1 Intervention
In this arm subjects will receive 3 fecal microbiota transplants at 1 monthly intervals at 1.5, 2.5 and 3.5 months (+/- 2 weeks) after transplant
Group II: Placebo EnemasPlacebo Group1 Intervention
In this arm subjects will receive 3 placebo transplants at 1 monthly intervals at 1.5, 2.5 and 3.5 months (+/- 2 weeks) after transplant
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplantation
2016
Completed Phase 2
~350

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,350 Total Patients Enrolled
Alka Goyal, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
23 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Fecal Microbiota Transplantation as a viable treatment?

"Considering the early-stage nature of this experiment, Fecal Microbiota Transplantation is rated a 1 on our safety scale due to the limited amount of evidence validating its efficacy and tolerability."

Answered by AI

For whom is this clinical trial an appropriate option?

"This clinical trial calls for 30 children and young adults aged 2-25 afflicted with ileocolitis. To be eligible, participants must possess physical fitness sufficient to undergo colonoscopy (per the American Society of Anesthesiologists' criteria) as judged by the Principal Investigator; additionally, they must have mild to moderately active CD that has been static for 4 weeks prior, and only in their colons or colons & terminal ileums. Lastly, applicants are expected to adhere faithfully to all study protocols and visit schedules along with complete logs at home."

Answered by AI

Are any new enrollees being accepted for this clinical trial?

"Data from clinicaltrials.gov demonstrates that the trial at hand is no longer actively recruiting patients, with its first posting on December 1st 2022 and most recent edit on March 16th 2021. Nevertheless, there are still 252 other trials seeking participants right now."

Answered by AI

Is this experiment recruiting elderly participants aged 85 or older?

"The minimum and maximum age requirements for this trial are 2 and 25 years old respectively, as stated by the eligibility criteria."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Randomized Trial Comparing Single vs. Maintenance Fecal Microbiota Transplant for Refractory Crohn's Disease in Children
Alka Goyal 2022. "Randomized Trial Comparing Single vs. Maintenance Fecal Microbiota Transplant for Refractory Crohn's Disease in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03747718.
~0 spots leftby Dec 2024
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