Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome

Irritable Bowel Syndrome (IBS) Clinical Trial

Official title:

Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092402
• Other study ID #: 2013/180
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: June 2019

Study information

• Verified date: August 2019
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2019
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Exclusion criteria for donors

1. Known organic gastrointestinal disease (e.g. IBD, IBS, chronic diarrhea or constipation)

2. Gastrointestinal malignancy or polyposis

3. History of major gastrointestinal surgery (e.g. gastric bypass)

4. Eosinophilic disorders of the gastrointestinal tract

5. Current communicable disease (e.g. upper respiratory tract infection)

6. Known or high risk of infectious diseases such as HIV, hepatitis A, B or C

7. Non-gastrointestinal malignancy

8. Dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation

9. Comorbidities such as metabolic syndrome, autoimmune diseases, allergies

10. Chronic pain syndromes (eg. chronic fatigue syndrome, fibromyalgia)

11. Severe or morbid obesity

12. Use of immunosuppressive or chemotherapy agents

13. Antimicrobial treatment or prophylaxis within the last 6 months

14. Females who are pregnant or breast-feeding

15. Known clinically significant abnormal laboratory values

16. Participation in high-risk sexual behaviors

17. Abuse of alcohol or drugs

18. Tattoo or body piercing within the last 6 months

19. Travel to areas with endemic diarrhea during the last 3 months

20. Positive stool testing for C. difficile toxin, ova, parasites, Giarda antigen, cryptosporidium antigen

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Irritable Bowel Syndrome (IBS)
• Syndrome

Intervention

Other:
• Fecal transplantation

Locations

Country	Name	City	State
Sweden	University Hospital Örebro	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

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