Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02092402

Enrollment

Registered

2014-03-20

Start date

2013-09-30

Completion date

2019-06-30

Last updated

2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

Fecal transplantation, microbiota transplantation, irritable bowel syndrome, IBS

Brief summary

The purpose of this study is to investigate the effect of fecal microbiota transplantation (FMT) on the symptoms of irritable bowel syndrome (IBS) patients.

Interventions

OTHERFecal transplantation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

for patients 1. Signed informed consent 2. Fulfilled Rome III diagnostic criteria for IBS, and frequency of IBS pain or discomfort for at least 2 days a week in the last 12 weeks 3. Age: 18-65 years

Exclusion criteria

for patients 1. High proportion of butyrate-producing microbiota in fecal samples 2. Known organic gastrointestinal disease (e.g. IBD) 3. Previous complicated gastrointestinal surgery 4. Non-gastrointestinal malignancy 5. Dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation 6. Females who are pregnant or breast-feeding 7. Severe endometriosis 8. Antimicrobial treatment 4 weeks prior to first screening visit 9. Antimicrobial prophylaxis (eg. acne, urinary tract infection) 10. Regular consumption of probiotic products 4 weeks prior to randomization 11. Recently (within the last 3 months) diagnosed lactose intolerance 12. Celiac disease 13. Abuse of alcohol or drugs 14. Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial Inclusion criteria for donors 1. Signed informed consent 2. High-butyrate producing microbiota in fecal samples 3. Age: 18-65 years

Design outcomes

Primary

Measure	Time frame
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS version of the gastrointestinal symptom rating scale (GSRS-IBS)	6 months

Secondary

Measure	Time frame
Effect of fecal transplantation on IBS patients' visceral perception (Pain scores on the visual analogue scale during barostat procedure)	2 months
Effect of fecal transplantation on IBS patients' composition of mucosal microbiota (HITChip analysis)	2 months
Effect of fecal transplantation on IBS patients' composition of fecal microbiota (HITChip analysis)	6 months
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the hospital and anxiety depression scale (HADS)	6 months
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS - severity scoring system (IBS-SSS)	6 months
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the health-related quality of life questionnaire for IBS patients (IBS-QOL)	6 months
Effect of fecal microbiota transplantation on the general health of IBS patients using the SF-36 survey	6 months
Effect of fecal transplantation on IBS patients' mucosal immune cell composition (lymphocyte fingerprinting using flow cytometry)	2 months

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026