NCT02788071

Brief Summary

The purpose of this study is to investigate if fecal microbiota transplantation (FMT) will result in improvement in clinical outcome in patients with irritable bowel syndrome (IBS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 30, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 2, 2017

Status Verified

August 1, 2017

Enrollment Period

9 months

First QC Date

May 30, 2016

Last Update Submit

August 1, 2017

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel SyndromeFecal Microbiota TransplantationMicrobiota

Outcome Measures

Primary Outcomes (1)

  • symptoms score

    Measured by the Irritable bowel syndrome - severity symptom score (IBS-SSS)

    12 weeks

Secondary Outcomes (4)

  • Change in microbiota diversity

    Day 4, 4 weeks, 12 weeks and 24 weeks

  • Microbiota diversity IBS patients

    Baseline

  • Microbiota diversity in healthy donors

    Baseline

  • Change in Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Questionnaire Scores

    Baseline, 4 weeks, 12 weeks and 24 weeks

Study Arms (2)

FMT capsules

EXPERIMENTAL

FMT capsules

Dietary Supplement: FMT capsules

FMT placebo

PLACEBO COMPARATOR

Placebo capsules

Dietary Supplement: FMT placebo

Interventions

FMT capsulesDIETARY_SUPPLEMENT

25 capsules per day for 12 days

FMT capsules
FMT placeboDIETARY_SUPPLEMENT

25 capsules per day for 12 days

FMT placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Fulfilled Rome III diagnostic criteria for IBS
  • Moderate-severe disease activity (IBS-Symptom Severity Score ≥175)
  • Able to read and speak Danish
  • Normal colonoscopy at age ≥ 40 years (performed within 1 year) or blood in stool

You may not qualify if:

  • Other chronic gastrointestinal disease
  • Positive fecal sample with enteropathogenic microorganisms or Clostridium difficile
  • Positive screening for HIV, Hepatitis B or HCV antibody
  • Surgical interventions in the gastrointestinal region (except for appendectomy, hernia repair, cholecystectomy, and gynecological and urological procedures)
  • Psychiatric disorder
  • Fecal calprotectin ≥ 50 mg/kg
  • Abuse of alcohol or drugs
  • Medications other than birth control pills, hormone supplements, allergies and asthma agents, blood pressure and cholesterol lowering agents, proton pump inhibitors and non-prescription medicines
  • Abnormal screening biochemistry
  • Abnormal colonoscopy findings
  • Pregnant, planned pregnancy or breastfeeding females
  • Age between 18-45 years
  • Past and current healthy
  • Normal weight (BMI between 18,5-24,9 kg/m2)
  • Normal bowel movements (defined as 1-2 per day and type 3-4 at Bristol Stool Form Scale)
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aleris Hamlet Hospitaler, København

Copenhagen, Søborg, 2760, Denmark

Location

Related Publications (1)

  • Halkjaer SI, Christensen AH, Lo BZS, Browne PD, Gunther S, Hansen LH, Petersen AM. Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study. Gut. 2018 Dec;67(12):2107-2115. doi: 10.1136/gutjnl-2018-316434. Epub 2018 Jul 6.

    PMID: 29980607DERIVED

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

  • Alice Højer Christensen, MD, PhD

    Aleris-Hamlet Hospitaler København

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 30, 2016

First Posted

June 2, 2016

Study Start

October 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

August 2, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

Locations

DK(1)