Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome
NCT ID: NCT02092402
Last Updated: 2019-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
17 participants
INTERVENTIONAL
2013-09-30
2019-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Faecal Microbiota Transplantation (FMT) in Patients With IBSmechanism(s) of Action
NCT04236843
Donor Versus Autologous Fecal Microbiota Transplantation for Irritable Bowel Syndrome
NCT04691544
Donor Selection for Faecal Microbiota Transplantation in Irritable Bowel Syndrome
NCT06171126
A Study to Evaluate Fecal Microbiota Transplantation Engraftment in IBS
NCT02847481
Fecal Microbiota Transplantation in Irritable Bowel Syndrome With Bloating
NCT02299973
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Fecal transplantation of own stool
Autologous fecal transplantation (own stool)
Fecal transplantation
Fecal transplantation (stool from donor)
Allogeneic fecal transplantation (from donor)
Fecal transplantation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fecal transplantation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
1. Signed informed consent
2. High-butyrate producing microbiota in fecal samples
3. Age: 18-65 years
Exclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Örebro University, Sweden
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Robert Brummer
MD, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert J Brummer, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Örebro, Department of Gastroenterology and Örebro University, School of Health and Medical Sciences, Faculty of Medicine and Health, Örebro, Sweden
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Örebro
Örebro, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013/180
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.