Irritable Bowel SyndromePhase 2NCT02328547

Fecal Microbiota Transplantation for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome

A Phase 2 study testing Fecal microbiota transplantation capsules in people with Irritable Bowel Syndrome, run by Montefiore Medical Center at 3 sites 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 objectives of this study are (1) to determine the efficacy of fecal microbiota transplantation (FMT), given as oral capsules, compared with placebo for the treatment of refractory diarrhea-predominant irritable bowel syndrome (IBS-D); (2) determine the impact of FMT on the intestinal microbiome of patients with… Read more about this study

Who is it for?: Ages 19 to 65 years
Conditions the study is for: Irritable Bowel Syndrome
What is being tested?: Fecal microbiota transplantation capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 3 sitesUnited States
Study dates: May 2015to Mar 2018
Phase: Phase 2
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 19 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

age 19-65 years
established diagnosis of IBS-D as determined by Rome III Criteria
moderate-severe disease activity (as determined by an IBS-Symptom Severity Score ≥175)
persistent symptoms despite conventional therapy
normal colonoscopy with biopsies in the past for work-up of IBS symptoms
negative work-up for celiac disease either by duodenal biopsies or negative serologies

Who cannot join

pregnancy
nursing
cognitive impairment or severe neuropsychiatric comorbidities who are incapable of providing their own informed consent
severely immunocompromised or immunosuppressed patients (e.g., organ transplant recipients, severe neutropenia with an absolute neutrophil count of <500cells/mL, current treatment or treatment within 3 months with anti-neoplastic agents and HIV-positive patients with CD4 counts <200cells/mm^3)
treated with any antibiotics in the 3 months prior to FMT
GI symptoms can be explained by the presence of an underlying organic disease including, underlying inflammatory bowel disease, infectious enteritis, previously established and untreated small intestinal bacterial overgrowth or known motility disorder

Show all 15Show fewer

previous FMT
severe (anaphylactic) food allergy
unable to comply with protocol requirements
American Society of Anesthesiologists (ASA) Physical Status classification IV and V
acute illness or fever on the day of planned FMT will be excluded (not randomized) with the option of including that subject at a future date
new antidepressant started or dose of antidepressant change <3 months prior to enrollment
elevated ESR or CRP within the past 3 months
baseline laboratory abnormalities on CBC, chemistry or liver tests
pain score >75 on IBS-SSS

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Medical Research Center of Connecticut
Hamden, Connecticut, 06518
Concorde Medical Group
New York, New York, 10016
Montefiore Medical Center
The Bronx, New York, 10467

Other trials in United States

About this study

Official title: Randomized, Double-blinded, Placebo-controlled Trial of Fecal Microbiota Transplantation (FMT) for Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Read the detailed description

This is a multicenter study including Montefiore Medical Center, Concorde Medical Group PLLC and the Medical Research Center of Connecticut/Yale-New Haven Hospital Langone Medical Center. Patients with IBS-D will be recruited from outpatient gastroenterology clinics at these institutions and referrals from the medical community.

FMT capsules and placebo capsules, provided by OpenBiome, Medford, MA, will be used for this study. Patients will be randomized to undergo FMT using fecal capsules (experimental group) or placebo capsules (control group) via a computer-generated program. All patients will cross-over into the alternate arm of the study at 12 weeks. Therefore, all patients enrolled will receive the experimental drug during the course of the study. Each patient will be enrolled in the study for a total of 6 months.

Intestinal microbiome analyses using DNA sequencing and non-cultivation-based approaches (16S DNA technology) will be performed in all patients in the experimental and control groups to assess stability of the microbiome over time.

Conditions: Irritable Bowel Syndrome
Being tested: Fecal microbiota transplantation capsules, Placebo capsules
Keywords: fecal microbiota transplantation, diarrhea-predominant
Medical subject headings: Irritable Bowel Syndrome

What participants receive

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

Fecal microbiota transplantation capsulesDrug
Also called FMT oral capsules
Fecal microbiota transplantation capsules contain extensively screened donor stool and are prepared by OpenBiome, Medford, MA.
Placebo capsulesDrug
Placebo capsules prepared by OpenBiome, Medford, MA

Study groups in NCT02328547
Study group	Role	What they receive
FMT capsules	Experimental	Intervention: Fecal microbiota transplantation capsules containing extensively screened donor stool, prepared by OpenBiome, Medford, MA. 25 FMT capsules will be take on three consecutive days. Receives: Drug: Fecal microbiota transplantation capsules
Placebo capsules	Placebo comparator	Intervention: Placebo capsules that do not contain donor stool or any active drug, prepared by OpenBiome, Medford, MA. 25 placebo capsules will be taken on three consecutive days. Receives: Drug: Placebo capsules

What is being measured

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

Within and Between Group Comparisons of Disease Severity as Determined by Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS)
Within and between group comparisons of changes (from baseline) in Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS), obtained via administration of a Questionnaire, for each of the two arms/groups (FMT capsules first, and placebo capsules first). The scale range was 0-500 (min-max). Scores were averaged among time points to yield an overall mean score. Higher scores were indicative of greater disease severity (worse outcome). Subjects were categorized as having mild (75-175), moderate (175-300), or severe (>300) irritable bowel syndrome (IBS) based on symptomology.
Only the following time points were analyzed: Baseline vs Week 12 and Week 24.
Measured: Baseline, Week 12 (before cross-over), Week 24

Secondary outcomes (15)

Within and Between Group Comparisons of Quality of Life as Determined by the Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Score
Within and between group comparisons of changes (from baseline) in Irritable Bowel Syndrome-Quality of Life (IBS-QOL), obtained via administration of a Questionnaire, for each of the two arms/groups (FMT capsules first, and placebo capsules first). Irritable Bowel Syndrome-Quality of Life (IBS-QOL) is administered via a questionnaire of 34 items each with an individual five-point response scale. The responses to these items are summed and averaged for a total score and then transformed to a 100-point scale for ease of interpretation based on a validated method. IBS-QOL is measured on a scale range of 0-100. Higher IBS-QOL scores are indicative of a better IBS-specific quality of life.
Only the following time points were analyzed: Baseline vs Week 12
Measured: Baseline, Week 12 (before cross-over), Week 24
Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)
Microbiota composition before and after FMT were assessed among FMT responders and FMT non-responders. Only patients who received FMT capsules at the start of this clinical trial were included. Placebo capsule recipients were not included in these analyses. Data were analyzed up to 12 weeks and not beyond. Microbiome data following cross-over were not analyzed because of the potential for carry-over and order effects in the second half of the trial.
Outcomes assessed included alpha and beta diversity (Jensen-Shannon divergence) and abundance of Bacteroidetes, Firmicutes and Prevotella. All of the microbiome data that were analyzed are included in the table below. No additional microbiome data from this clinical trial were analyzed.
Measured: Baseline, Week 1, Week 4 and Week 12
Anxiety as Measured by the Hospital Anxiety and Depression Scale (HADS). HADS-A (Anxiety)
Anxiety at baseline and at the time of cross-over (Week 12) as measured by Hospital Anxiety and Depression Scale (HADS). HADS-A (Anxiety)
The Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale which was administered via questionnaire. Seven of the items relate to anxiety (HADS-A) and seven relate to depression (HADS-D). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. Higher HADS scores are indicative of more severe depression and anxiety.
Only the following time points were analyzed: Baseline vs Week 12
Measured: Baseline, Week 12 (before cross-over), Week 24
Depression as Measured by the Hospital Anxiety and Depression Scale (HADS). HADS-D (Depression)
Depression at baseline and at the time of cross-over (Week 12) as measured by Hospital Anxiety and Depression Scale (HADS). HADS-D (Depression)
The Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale which was administered via questionnaire. Seven of the items relate to anxiety (HADS-A) and seven relate to depression (HADS-D). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. Higher HADS scores are indicative of more severe depression and anxiety.
Only the following time points were analyzed: Baseline vs Week 12
Measured: Baseline, Week 12 (before cross-over), Week 24
Bowel Consistency as Measured by the Bristol Stool Form Scale (BSFS)
Bowel consistency as measured by the Bristol Stool Form Scale on a daily basis.
The Bristol Stool Form Scale was administered via questionnaire. This scale is a diagnostic medical tool designed to classify the form of human feces into seven categories. Assigned categories range from 1-7 based on appearance of the stool. Type 1 and 2 stools indicate constipation. Type 4 are the ideal stools as they are easy to defecate while not containing excess liquid, Type 5 tends towards diarrhea, and Types 6 and 7 indicate diarrhea.
Only the following time points were analyzed: Baseline vs Week 12
Measured: Baseline, Week 12 (before cross-over), Week 24
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
The total number of participants in each of the arms/groups (FMT and Placebo) who experienced at least one adverse event (AE) as recorded in patient diaries.
Measured: All AEs over 24 weeks
Satisfaction With Fecal Microbiota Transplantation (FMT)
Weekly assessments of satisfaction with the Fecal Microbiota Transplantation (FMT) will be recorded in patient diaries.
Measured: Week 12 following administration of FMT
Change in Bowel Habits and Abdominal Pain After Fecal Microbiota Transplantation (FMT)
Degree of improvement in bowel habits and abdominal pain will be recorded in patient diaries.
Measured: Week 12 following administration of FMT
Number of Doctor or Emergency Department (ED) Visits Post-Fecal Microbiota Transplantation (Post-FMT) for Irritable Bowel Syndrome-D (IBS-D) Related Symptoms
The number of doctor or ED visits post-Fecal Microbiota Transplantation for Irritable Bowel Syndrome-D (IBS-D) related symptoms will be recorded in patient diaries.
Measured: Week 12 following administration of FMT
Initiation of New Medications Post-FMT for the Treatment of IBS-D Symptoms
Initiation of new medications post-FMT for the treatment of IBS-D symptoms will be recorded in patient diaries.
Measured: Week 12 following administration of FMT
Patient Attitudes Towards Fecal Microbiota Transplantation (FMT)
Patient attitudes towards Fecal Microbiota Transplantation (FMT) will be recorded in patient diaries.
Measured: Week 12 following administration of FMT
Tolerability of Fecal Microbiota Transplantation (FMT)
Tolerability of Fecal Microbiota Transplantation (FMT) will be maintained in patient diaries.
Measured: Week 12 following administration of FMT
Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)
Microbiota composition before and after FMT were assessed among FMT responders and FMT non-responders. Only patients who received FMT capsules at the start of this clinical trial were included. Placebo capsule recipients were not included in these analyses. Data were analyzed up to 12 weeks and not beyond. Microbiome data following cross-over were not analyzed because of the potential for carry-over and order effects in the second half of the trial.
Outcomes assessed included alpha and beta diversity (Jensen-Shannon divergence) and abundance of Bacteroidetes, Firmicutes and Prevotella. All of the microbiome data that were analyzed are included in the table below. No additional microbiome data from this clinical trial were analyzed.
The Alpha Diversity Index is a quantitative measure that reflects the diversity of bacterial species in a sample. The greater the index, the more diverse the intestinal microbiota.
Measured: Baseline, Week 1, Week 4 and Week 12
Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)
Microbiota composition before and after FMT were assessed among FMT responders and FMT non-responders. Only patients who received FMT capsules at the start of this clinical trial were included. Placebo capsule recipients were not included in these analyses. Data were analyzed up to 12 weeks and not beyond. Microbiome data following cross-over were not analyzed because of the potential for carry-over and order effects in the second half of the trial.
Outcomes assessed included alpha and beta diversity (Jensen-Shannon divergence) and abundance of Bacteroidetes, Firmicutes and Prevotella. All of the microbiome data that were analyzed are included in the table below. No additional microbiome data from this clinical trial were analyzed.
The Beta Diversity Index or Jensen-Shannon divergence is a quantitative measure that reflects the diversity of bacterial species between two different regions. The greater the index, the more diverse the intestinal microbiota between the two regions.
Measured: Baseline, Week 1, Week 4 and Week 12
Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)
Microbiota composition before and after FMT were assessed among FMT responders and FMT non-responders. Only patients who received FMT capsules at the start of this clinical trial were included. Placebo capsule recipients were not included in these analyses. Data were analyzed up to 12 weeks and not beyond. Microbiome data following cross-over were not analyzed because of the potential for carry-over and order effects in the second half of the trial.
Outcomes assessed included alpha and beta diversity (Jensen-Shannon divergence) and abundance of Bacteroidetes, Firmicutes and Prevotella. All of the microbiome data that were analyzed are included in the table below. No additional microbiome data from this clinical trial were analyzed. Information on abundance of Prevotella was only available at baseline and week 1.
Measured: Baseline and Week 1

Timeline

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

May 2015Mar 2018

First posted31 Dec 2014 (estimated)
Study startMay 2015
Primary completionOct 2017
Study completionMar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02328547
Sponsor's protocol ID: 2014-3941
Status last verified: Jun 2019
First submitted: 16 Dec 2014
Last updated: 2 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Aroniadis OC, Brandt LJ, Oneto C, Feuerstadt P, Sherman A, Wolkoff AW, Kassam Z, Sadovsky RG, Elliott RJ, Budree S, Kim M, Keller MJ. Faecal microbiota transplantation for diarrhoea-predominant irritable bowel syndrome: a double-blind, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2019 Sep;4(9):675-685. doi: 10.1016/S2468-1253(19)30198-0. Epub 2019 Jul 17.
PubMed 31326345

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-blinded, Placebo-controlled Trial of Fecal Microbiota Transplantation (FMT) for Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
ClinicalTrials.gov ID: NCT02328547
Acronym / sponsor ID: 2014-3941
Conditions: Irritable Bowel Syndrome
Keywords: fecal microbiota transplantation, diarrhea-predominant
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Montefiore Medical CenterUniversity, hospital or other
Study start: May 2015 (actual)
Primary completion: Oct 2017 (actual)
Study completion: Mar 2018 (actual)
First posted: 31 Dec 2014 (estimated)
Results: Posted 2 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
FMT capsules	Experimental	Drug: Fecal microbiota transplantation capsulesIntervention: Fecal microbiota transplantation capsules containing extensively screened donor stool, prepared by OpenBiome, Medford, MA. 25 FMT capsules will be take on three consecutive days.
Placebo capsules	Placebo comparator	Drug: Placebo capsulesIntervention: Placebo capsules that do not contain donor stool or any active drug, prepared by OpenBiome, Medford, MA. 25 placebo capsules will be taken on three consecutive days.

Who may qualify

Ages: 19 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

age 19-65 years
established diagnosis of IBS-D as determined by Rome III Criteria
moderate-severe disease activity (as determined by an IBS-Symptom Severity Score ≥175)
persistent symptoms despite conventional therapy
normal colonoscopy with biopsies in the past for work-up of IBS symptoms

Key exclusion criteria (15 listed)

pregnancy
nursing
cognitive impairment or severe neuropsychiatric comorbidities who are incapable of providing their own informed consent
severely immunocompromised or immunosuppressed patients (e.g., organ transplant recipients, severe neutropenia with an absolute neutrophil count of <500cells/mL, current treatment or treatment within 3 months with anti-neoplastic agents and HIV-positive patients with CD4 counts <200cells/mm^3)
treated with any antibiotics in the 3 months prior to FMT

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fecal microbiota transplantation capsulesAlso: FMT oral capsulesFecal microbiota transplantation capsules contain extensively screened donor stool and are prepared by OpenBiome, Medford, MA.	Drug	FMT capsules
Placebo capsulesPlacebo capsules prepared by OpenBiome, Medford, MA	Drug	Placebo capsules

Primary outcome

Within and Between Group Comparisons of Disease Severity as Determined by Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS)
Time frame: Baseline, Week 12 (before cross-over), Week 24
Within and between group comparisons of changes (from baseline) in Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS), obtained via administration of a Questionnaire, for each of the two arms/groups (FMT capsules first, and placebo capsules first). The scale range was 0-500 (min-max). Scores were averaged among time points to yield an overall mean score. Higher scores were indicative of greater disease severity (worse outcome). Subjects were categorized as having mild (75-175), moderate (175-300), or severe (>300) irritable bowel syndrome (IBS) based on symptomology. Only the following time points were analyzed: Baseline vs Week 12 and Week 24.

15 secondary outcomes

Within and Between Group Comparisons of Quality of Life as Determined by the Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Score
Time frame: Baseline, Week 12 (before cross-over), Week 24
Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)
Time frame: Baseline, Week 1, Week 4 and Week 12
Anxiety as Measured by the Hospital Anxiety and Depression Scale (HADS). HADS-A (Anxiety)
Time frame: Baseline, Week 12 (before cross-over), Week 24
Depression as Measured by the Hospital Anxiety and Depression Scale (HADS). HADS-D (Depression)
Time frame: Baseline, Week 12 (before cross-over), Week 24
Bowel Consistency as Measured by the Bristol Stool Form Scale (BSFS)
Time frame: Baseline, Week 12 (before cross-over), Week 24
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: All AEs over 24 weeks
Satisfaction With Fecal Microbiota Transplantation (FMT)
Time frame: Week 12 following administration of FMT
Change in Bowel Habits and Abdominal Pain After Fecal Microbiota Transplantation (FMT)
Time frame: Week 12 following administration of FMT
Number of Doctor or Emergency Department (ED) Visits Post-Fecal Microbiota Transplantation (Post-FMT) for Irritable Bowel Syndrome-D (IBS-D) Related Symptoms
Time frame: Week 12 following administration of FMT
Initiation of New Medications Post-FMT for the Treatment of IBS-D Symptoms
Time frame: Week 12 following administration of FMT
Patient Attitudes Towards Fecal Microbiota Transplantation (FMT)
Time frame: Week 12 following administration of FMT
Tolerability of Fecal Microbiota Transplantation (FMT)
Time frame: Week 12 following administration of FMT
Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)
Time frame: Baseline, Week 1, Week 4 and Week 12
Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)
Time frame: Baseline, Week 1, Week 4 and Week 12
Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)
Time frame: Baseline and Week 1

Results and safety

Results posted to the registry on 2 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fecal Microbiota Transplantation Capsules First, Then Placebo	25	22
Placebo Capsules First, Then Fecal Microbiota Transplantation	23	23

Primary outcome: Within and Between Group Comparisons of Disease Severity as Determined by Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS)

Time frame: Baseline, Week 12 (before cross-over), Week 24. Mean (Standard Deviation). Unit: units on a scale

Measure	FMT Capsules, Followed by Placebo Capsules n = 25	Placebo Capsules, Followed by FMT Capsules n = 23
Baseline	282 (65)	309 (64)
Week 12	221 (105)	236 (95)
Week 24	208 (111)	157 (101)

Population analysed: Participants were randomized to FMT first followed by placebo (n=25) OR to placebo first followed by FMT (n=23) and analyzed in these groups. Participants who received FMT 1st and those who received FMT 2nd were not pooled together into one group because of potential carry-over effects.

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FMT Capsules	0 of 48 (0%)	23 of 48 (47.9%)	0 of 48
Placebo Capsules	1 of 48 (2.1%)	24 of 48 (50%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31326345Aroniadis OC, Brandt LJ, Oneto C, Feuerstadt P, Sherman A, Wolkoff AW, Kassam Z, Sadovsky RG, Elliott RJ, Budree S, Kim M, Keller MJ. Faecal microbiota transplantation for diarrhoea-predominant irritable bowel syndrome: a double-blind, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2019 Sep;4(9):675-685. doi: 10.1016/S2468-1253(19)30198-0. Epub 2019 Jul 17.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Olga C Aroniadis, MD principal investigator

Montefiore Medical Center

Lawrence J Brandt, MD principal investigator

Montefiore Medical Center

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fecal microbiota transplantation capsules in people with Irritable Bowel Syndrome, run by Montefiore Medical Center at 3 sites 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 6 inclusion and 15 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 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 2 Jul 2019). 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?

Within and Between Group Comparisons of Disease Severity as Determined by Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS) (time frame: Baseline, Week 12 (before cross-over), Week 24). 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 NCT02328547, 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 Jul 2019.