CompletedNCT03006809Updated Apr 28, 2021

Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis

A Phase 1 interventional study of Fecal Microbiota Transplantation (FMT), OpenBiome and pretreatment antibiotics in Ulcerative Colitis, sponsored by Najwa Elnachef. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2021-04-28.

Sponsored by Najwa Elnachef · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years to 64 Years
Sex: All

Study summary

This is a prospective unblinded, randomized trial for the use of Fecal Microbiota Transplantation (FMT) for the treatment of Ulcerative Colitis (UC), in combination with or without antibiotic pretreatment.

Read the detailed description

This is a prospective open-label, randomized trial for the use of Fecal Microbiota Transplantation (FMT) for the treatment of Ulcerative Colitis (UC), in combination with or without antibiotic pretreatment.

This trial involves 11 study visits at UCSF in San Francisco, CA.

The routes of administration will be via colonoscopy for all subjects with maintenance therapy administered orally (i.e. using encapsulated FMT) for half of the subjects and per rectum by enema in the other half of the subjects. Additionally, the utility of pretreatment antibiotics will be assessed.

Conditions studied

Ulcerative Colitis

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Keywords

Ulcerative colitis
FMT
fecal transplant

Who can participate

Ages eligible: 18 Years to 64 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients with history of mild to moderate Ulcerative Colitis confirmed by endoscopy and pathology.
Total Mayo score 4-9, endoscopic subscore ≥1; patients who have not had endoscopic evaluation within one year of enrollment will have flexible sigmoidoscopy for evaluation.
Age 18 - 64 and deemed otherwise healthy at the discretion of the investigator.
Concurrent therapies with mesalamine (stable x 4 weeks), immunomodulators (stable x 3 months), and biologic agents (stable x 3 months) will be allowed to continue during study.
If patient is on prednisone, the dose must be ≤ 10mg/day at the time of treatment and will be weaned by 2.5mg/week during the study period.

Exclusion criteria

Exclusion Criteria:

Severe or refractory UC defined as Mayo score ≥10, endoscopic disease activity score 3
Untreated enteric infection (positive stool test for any of the following: Clostridium difficile, Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic E. coli or other enteric infection at the discretion of the investigator.
History of colectomy
Disease limited to distal proctitis
Patients taking probiotics within 6 weeks of planned FMT therapy.
Severe immunodeficiency, inherited or acquired (e.g. HIV, chemotherapy or radiation therapy)
Patients with the following laboratory abnormalities: absolute neutrophil count (ANC) \< 1000 / µl, platelets \<50 x 10\^9 /L,, hemoglobin \<6.5 g/dL..
History of anaphylaxis (severe allergic reaction) to food allergens (e.g. tree nuts, shellfish)
Dysphagia (oropharyngeal, esophageal, functional, neuromuscular)
History of recurrent aspiration episodes
Documented severe gastroparesis
Active intestinal obstruction
Patients with renal insufficiency (GFR \< 50ml/min)
Allergy to the following generally regarded as safe ingredients (GRAS): glycerol, acid resistant HPMC, gellan gum, cocoa butter, titanium dioxide
Adverse event attributable to any previous FMT
Allergy/intolerance to proton pump inhibitor therapy
Allergy/intolerance to vancomycin, metronidazole, or neomycin.
Non-steroidal inflammatory medications (NSAIDs) as long-term treatment, defined as use for at least 4 days a week each month.
Cholestyramine use
Any condition in which the investigator thinks the FMT treatment may pose a health risk (e.g. severely immunocompromised)
Simultaneous participation in another interventional clinical trial
Patients who are pregnant, breast feeding or planning pregnancy during study trial period.
During the trial period until one week after the trial end: Non-use of appropriate contraceptives in females of childbearing potential (e.g. condoms, intrauterine device (IUD), hormonal contraception, or other means considered adequate by the responsible investigator) or in males with a child-fathering potential (condoms, or other means considered adequate by the responsible investigator during treatment) or well-founded doubt about the patient's cooperation
Patients with any other significant medical condition that could confound or interfere with evaluation of safety, tolerability or prevent compliance with the study protocol at the discretion of the investigator
Life expectancy \<6 months

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 30 participants (actual)

Study arms

Experimental
1
pretreatment antibiotics + FMT delivered by colonoscopy + FMT capsules per week x 6 weeks
Biological: Fecal Microbiota Transplantation (FMT), OpenBiome · Other: pretreatment antibiotics
Experimental
2
no antibiotics, FMT delivered by colonoscopy + FMT capsules per week x 6 weeks
Biological: Fecal Microbiota Transplantation (FMT), OpenBiome
Experimental
3
pretreatment antibiotics + FMT delivered by colonoscopy + FMT delivered by enema once per week x 6 weeks
Biological: Fecal Microbiota Transplantation (FMT), OpenBiome · Other: pretreatment antibiotics
Experimental
4
no antibiotics, FMT delivered by colonoscopy + FMT delivered by enema once per week x 6 weeks
Biological: Fecal Microbiota Transplantation (FMT), OpenBiome

Interventions

BiologicalFecal Microbiota Transplantation (FMT), OpenBiome
Delivered by colonoscopy, enema or orally (as capsules)
Otherpretreatment antibiotics
5 day course (vancomycin PO 500mg bid, metronidazole PO 500mg bid, and neomycin PO 500mg bid) starting 6 days prior FMT
Also known as: vancomycin, metronidazole, neomycin

What researchers measure

Primary outcomes

The occurrence of a Serious Adverse event (SAE), solicited and unsolicited AE, new gastrointestinal medical condition and diagnoses from FMT treatment or new infection from FMT treatment
safety endpoint
Time frame: up to 1 year
Steroid-free Clinical Remission at week 9 + endoscopic remission or response defined as total Mayo score ≤ 2 with all four sub-scores ≤ 1 and a ≥ 1 point reduction in endoscopy sub-score
Time frame: 8 weeks post initial treatment

Secondary outcomes

Changes in microbiome with FMT therapy. Changes in the microbiome: assessed by frequent stool sampling for 16S rRNA analysis prior to each FMT therapy and after the last capsule/enema dose
Time frame: up to 1 year
Clinical Response: decrease in Mayo score by ≥ 3 points, decrease in bleeding subscore by ≥ 1, or absolute subscore of 0-1
Time frame: 8 weeks post initial treatment
Progression of disease defined by initiation of anti-TNF agents or Corticosteroids: Initiation of anti-TNF agents (such as infliximab, adalimumab, certolizumab, vedolizumab and steroids). Includes time gap until additional agents are started.
Time frame: 2, 4 and 8 weeks post initial FMT
Progression of disease defined by increase in dosages of current UC medications
Time frame: 2, 4 and 8 weeks post initial FMT
Progression of disease defined by time to colectomy
Time frame: up to one year post initial FMT
Time to death secondary to UC
Time frame: up to one year post initial FMT
Progression of disease defined by clinical flare (Time to next flare)
Time frame: 2, 4 and 8 weeks post initial FMT
Increase in Quality of Life (based on RAND SF-36 survey and score)
Time frame: 8 weeks post initial FMT
Changes in Mood/Depression Score (based on PHQ-9 survey and score)
Time frame: 8 weeks post initial FMT

Study locations

1 site

UCSF Division of Gastroenterology at Mount Zion
San Francisco, California 94143, United States

References and documents

Publications

Smith BJ, Piceno Y, Zydek M, Zhang B, Syriani LA, Terdiman JP, Kassam Z, Ma A, Lynch SV, Pollard KS, El-Nachef N. Strain-resolved analysis in a randomized trial of antibiotic pretreatment and maintenance dose delivery mode with fecal microbiota transplant for ulcerative colitis. Sci Rep. 2022 Apr 1;12(1):5517. doi: 10.1038/s41598-022-09307-5. PubMed 35365713 ↗

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03006809
Lead sponsor: Najwa Elnachef
Responsible party: Najwa Elnachef (Assistant Clinical Professor, University of California, San Francisco) — Sponsor-investigator
First posted: Dec 30, 2016
Start date: Mar 2, 2017
Primary completion: May 4, 2020
Completion: Apr 4, 2021
Last update: Apr 28, 2021

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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