CLINICAL TRIAL

Fecal Microbiota transplant (FMT) for Ulcer

Waitlist Available · 18+ · All Sexes · Hamilton, Canada

This study is evaluating whether fecal microbiota transplantation (FMT) can induce remission in patients with ulcerative colitis (UC).

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About the trial for Ulcer

Eligible Conditions
Colitis, Ulcerative · Colitis · Ulcer · Ulcerative Colitis Flare

Treatment Groups

This trial involves 2 different treatments. Fecal Microbiota Transplant (FMT) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Fecal Microbiota transplant (FMT)
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Ulcer or one of the other 3 conditions listed above. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients aged 18 or over
Active UC defined as a Mayo score (7) >3
A Mayo endoscopic score (7) >0
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 9 weeks and 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 9 weeks and 3 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Fecal Microbiota transplant (FMT) will improve 2 primary outcomes and 6 secondary outcomes in patients with Ulcer. Measurement will happen over the course of 9 weeks.

Stool microbiota predicting FMT success
9 WEEKS
Comparison of stool microbiota evaluated by 16s RNA and metagenomics in those achieving remission with FMT versus those that are not successful
Efficacy of FMT at relieving PRO2 symptoms
9 WEEKS
A score of zero on the first two questions of the Mayo Score
Efficacy of FMT donors at inducing UC remission
9 WEEKS
Suitability of FMT donors at inducing remission in active UC (remission defined as a Mayo score (7) < 3 with an endoscopic Mayo score = 0 at the end of 8 weeks of FMT).
Mucosal microbiota predicting FMT success
9 WEEKS
Comparison of mucosal microbiota evaluated by 16s RNA and metagenomics in those achieving remission with FMT versus those that are not successful
Efficacy of FMT at in inducing histological remission in active UC
9 WEEKS
Histological remission with no active inflammation on rectal and sigmoid biopsies
Efficacy of FMT at maintaining remission in UC
3 YEARS
Maintenance of remission of UC after three years in those who achieve initial remission with FMT. This is defined as no relapse over three years that requires any medical therapy other than more intense FMT therapy
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Who is running the study

Principal Investigator
P. M.
Paul Moayyedi, Principle Investigator
Hamilton Health Sciences Corporation

Patient Q & A Section

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

What is ulcer?

Most stools are only slightly pinkish-yellow, but there are a number of stool discolourations that may be seen with gastrointestinal hemorrhage; these should prompt urgent medical investigation.

Anonymous Patient Answer

What are common treatments for ulcer?

Gastrointestinal ulcer is a common condition. It is often associated with low plasma glutathione levels. Gastrointestinal ulcers might be treated, with a high rate (60%) of healing rate after 6-month treatment with vitamin C (0.5 g). Patients may also benefit from prokinetics (such as metoclopramide). Patients with aspirin-related ulcer should not be treated, as this might trigger GI bleeding"

Anonymous Patient Answer

What are the signs of ulcer?

Signs of ulcer include loss of appetite, nausea, frequent vomiting and diarrhoea.  Gastric ulcer usually presents with pain and occasional dark stools.  Peptic ulcer usually presents with vomiting or upper abdominal pain and may sometimes be associated with bloody diarrhea.  Diarrhoea may lead to dehydration and loss of fluid through vomiting and watery diarrhea.  Malabsorption can lead to loose stools, weight loss and anaemia (with iron deficiency being the most common cause).  In inflammatory bowel disease, symptoms tend to develop over weeks, months or years.  In sarcoidosis,  a long-standing chronic inflammatory reaction is seen in the lungs.

Anonymous Patient Answer

What causes ulcer?

The cause is multifactorial and includes ulcerative factors, stress components, and other contributing factors. Some risk factors have been implicated but their relative roles in the development of ulcers remain in question.

Anonymous Patient Answer

How many people get ulcer a year in the United States?

About 2 million Americans are hospitalized annually for upper GI-related reasons. The majority are ulcerative. Younger adults are most obviously affected. Most upper GI ulcer is attributable to habits or lifestyle, which vary widely from country to country.

Anonymous Patient Answer

Can ulcer be cured?

It seems that the risk factors such as age, smoking, alcohol, low socioeconomic status, high BMI, diabetes mellitus, and dyslipidaemia influences the development of ulcer in different areas of Saudi Arabia. The control of these risk factors will prevent the occurrence of ulcer and its complications.

Anonymous Patient Answer

What are the common side effects of fecal microbiota transplant (fmt)?

Side effects of fmt are common, however may be managed with simple measures. Side effects can be anticipated by the choice of recipients, such as in the case of severe immunocompromised patients.

Anonymous Patient Answer

What is the average age someone gets ulcer?

A growing population of patients has developed an increased frequency of advanced ulcer due to more prolonged periods of good or good-to-excellent nutrition. Such individuals are especially at risk for developing more refractory lesions as time progresses.

Anonymous Patient Answer

What does fecal microbiota transplant (fmt) usually treat?

Fmt treatment of steroid-treated [ulcerative colitis](https://www.withpower.com/clinical-trials/ulcerative-colitis) is safe and effective. Fmt has a higher rate of remission than observation. With steroid-resistant ulcerative colitis, in whom colonoscopy is ineffective or contraindicated, Fmt seems to control this disease with no side effects.

Anonymous Patient Answer

Is fecal microbiota transplant (fmt) safe for people?

FMT is associated with significantly fewer AEs than no intervention and achieves significant reduction in AEs compared with antibiotics. FMT appears to be safe, with no adverse effects observed to date. Future studies are needed to evaluate long-term efficacy of fmt.

Anonymous Patient Answer

Does fecal microbiota transplant (fmt) improve quality of life for those with ulcer?

Results from a recent clinical trial demonstrated that the improvement of fecal permeability and stool frequency were substantial and that fmt is a feasible and safe therapy for the improvement of ulcer-related QOL.

Anonymous Patient Answer

What is the primary cause of ulcer?

Acid has been established as the predominant bacterial cause of uncomplicated ulcer. It has not yet been proven to be the primary cause of simple ulcer for whom the acid theory is not applicable. When acid is suspected, it should be tested in both the presence and absence of ulcer. If acid is found in the presence of ulcer then acid is the definite aetiology. When acid is absent there appear to be other causes in uncomplicated ulcer.

Anonymous Patient Answer
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