NCT02423421

Brief Summary

The purpose of thus study is to determine if faecal microbiota transplantation will result in improvement in clinical outcomes in patients with irritable bowel syndrome.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

1.3 years

First QC Date

March 10, 2015

Last Update Submit

April 17, 2015

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • Global Assessment of relief of IBS symptoms.

    This assessment will be obtained by defining the response (Yes or No) to the following question. "Please consider how you felt in the past week in regard to your IBS, in particular your overall well-being, and symptoms of abdominal discomfort or pain, bloating or distension and altered bowel habit .Compared to the way you usually felt before the beginning of the trial, have you had adequate relief of your IBS-symptoms?"

    8 weeks

Secondary Outcomes (4)

  • Primary symptoms of IBS

    8 weeks

  • Quality of life

    8 weeks

  • Depression and Anxiety

    8 weeks

  • Safety as measured by occurrence of adverse events

    8 weeks

Other Outcomes (1)

  • Patient microbiota compositional profiles

    8 weeks

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

The treatment group will have faecal microbiota transplantation performed using stool from a healthy human donor

Other: Faecal microbiota transplantation

Placebo group

PLACEBO COMPARATOR

The placebo group will have autologous faecal microbiota transplantation performed.

Other: Faecal microbiota transplantation

Interventions

Faecal microbiota transplantationOTHER

Human Stool.

Placebo groupTreatment group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be considered eligible for enrolment into the study, subjects must;
  • Be able to give written informed consent.
  • Males and females aged \>18 and \<65
  • Have IBS as defined by the Rome III criteria

You may not qualify if:

  • Subjects will be excluded from the study if they meet any of the below criteria;
  • Are less than 18 and greater than 65 years of age.
  • Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal, endocrine, immunological, metabolic or any condition which contraindicates, in the investigators' judgment, entry to the study).
  • Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
  • Are receiving treatment involving experimental drugs.
  • If the subject has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.
  • Have a malignant disease or any concomitant end-stage organ disease Pregnancy
  • Use of antibiotics within 6 weeks of screening.
  • Use of systemic steroids within the last month.
  • Use of an antipsychotic within prior 3 months.
  • Have suffered from a major psychiatric disorder with the past two years.
  • Lactose intolerance.
  • Those \> 55 will be excluded if they have not had a sigmoidoscopy or colonoscopy within previous 5 years.
  • Any abdominal surgery other than hernia repair or appendicectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alimentary Pharmabiotic Centre, University College Cork

Cork, Cork, Ireland

RECRUITING

Related Publications (12)

  • Drossman DA, Camilleri M, Mayer EA, Whitehead WE. AGA technical review on irritable bowel syndrome. Gastroenterology. 2002 Dec;123(6):2108-31. doi: 10.1053/gast.2002.37095. No abstract available.

    PMID: 12454866BACKGROUND

  • Gwee KA, Graham JC, McKendrick MW, Collins SM, Marshall JS, Walters SJ, Read NW. Psychometric scores and persistence of irritable bowel after infectious diarrhoea. Lancet. 1996 Jan 20;347(8995):150-3. doi: 10.1016/s0140-6736(96)90341-4.

    PMID: 8544549BACKGROUND

  • Collins SM. A role for the gut microbiota in IBS. Nat Rev Gastroenterol Hepatol. 2014 Aug;11(8):497-505. doi: 10.1038/nrgastro.2014.40. Epub 2014 Apr 22.

    PMID: 24751910BACKGROUND

  • Ford AC, Talley NJ. Irritable bowel syndrome. BMJ. 2012 Sep 4;345:e5836. doi: 10.1136/bmj.e5836. No abstract available.

    PMID: 22951548BACKGROUND

  • Neal KR, Barker L, Spiller RC. Prognosis in post-infective irritable bowel syndrome: a six year follow up study. Gut. 2002 Sep;51(3):410-3. doi: 10.1136/gut.51.3.410.

    PMID: 12171965BACKGROUND

  • Jeffery IB, Quigley EM, Ohman L, Simren M, O'Toole PW. The microbiota link to irritable bowel syndrome: an emerging story. Gut Microbes. 2012 Nov-Dec;3(6):572-6. doi: 10.4161/gmic.21772. Epub 2012 Aug 16.

    PMID: 22895081BACKGROUND

  • Rajilic-Stojanovic M, Biagi E, Heilig HG, Kajander K, Kekkonen RA, Tims S, de Vos WM. Global and deep molecular analysis of microbiota signatures in fecal samples from patients with irritable bowel syndrome. Gastroenterology. 2011 Nov;141(5):1792-801. doi: 10.1053/j.gastro.2011.07.043. Epub 2011 Aug 5.

    PMID: 21820992BACKGROUND

  • van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.

    PMID: 23323867BACKGROUND

  • Kassam Z, Lee CH, Yuan Y, Hunt RH. Fecal microbiota transplantation for Clostridium difficile infection: systematic review and meta-analysis. Am J Gastroenterol. 2013 Apr;108(4):500-8. doi: 10.1038/ajg.2013.59. Epub 2013 Mar 19.

    PMID: 23511459BACKGROUND

  • Gough E, Shaikh H, Manges AR. Systematic review of intestinal microbiota transplantation (fecal bacteriotherapy) for recurrent Clostridium difficile infection. Clin Infect Dis. 2011 Nov;53(10):994-1002. doi: 10.1093/cid/cir632.

    PMID: 22002980BACKGROUND

  • Bakken JS, Borody T, Brandt LJ, Brill JV, Demarco DC, Franzos MA, Kelly C, Khoruts A, Louie T, Martinelli LP, Moore TA, Russell G, Surawicz C; Fecal Microbiota Transplantation Workgroup. Treating Clostridium difficile infection with fecal microbiota transplantation. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1044-9. doi: 10.1016/j.cgh.2011.08.014. Epub 2011 Aug 24.

    PMID: 21871249BACKGROUND

  • Vrieze A, Van Nood E, Holleman F, Salojarvi J, Kootte RS, Bartelsman JF, Dallinga-Thie GM, Ackermans MT, Serlie MJ, Oozeer R, Derrien M, Druesne A, Van Hylckama Vlieg JE, Bloks VW, Groen AK, Heilig HG, Zoetendal EG, Stroes ES, de Vos WM, Hoekstra JB, Nieuwdorp M. Transfer of intestinal microbiota from lean donors increases insulin sensitivity in individuals with metabolic syndrome. Gastroenterology. 2012 Oct;143(4):913-6.e7. doi: 10.1053/j.gastro.2012.06.031. Epub 2012 Jun 20.

    PMID: 22728514BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Fergus Shanahan, MD, DSc

    Professor and Chair Dept. of Medicine, University College Cork

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Donal Sheehan, MB BAO BCH

CONTACT

donal.sheehan@ucc.ie

Susan Rafferty - McArdle, PhD

CONTACT

+353 21 4901753s.rafferty@ucc.ie

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair Department of Medicine and Director Alimentary Pharmabiotic Centre, University College Cork

Study Record Dates

First Submitted

March 10, 2015

First Posted

April 22, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations

IE(1)