Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome

Inclusion criteria

for patients

• Signed informed consent
• 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
• Age: 18-65 years

Exclusion criteria

for patients

• High proportion of butyrate-producing microbiota in fecal samples
• Known organic gastrointestinal disease (e.g. IBD)
• Previous complicated gastrointestinal surgery
• Non-gastrointestinal malignancy
• Dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
• Females who are pregnant or breast-feeding
• Severe endometriosis
• Antimicrobial treatment 4 weeks prior to first screening visit
• Antimicrobial prophylaxis (eg. acne, urinary tract infection)
• Regular consumption of probiotic products 4 weeks prior to randomization
• Recently (within the last 3 months) diagnosed lactose intolerance
• Celiac disease
• Abuse of alcohol or drugs
• Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial

Inclusion criteria

for donors

• Signed informed consent
• High-butyrate producing microbiota in fecal samples
• Age: 18-65 years

Exclusion criteria

for donors

• Known organic gastrointestinal disease (e.g. IBD, IBS, chronic diarrhea or constipation)
• Gastrointestinal malignancy or polyposis
• History of major gastrointestinal surgery (e.g. gastric bypass)
• Eosinophilic disorders of the gastrointestinal tract
• Current communicable disease (e.g. upper respiratory tract infection)
• Known or high risk of infectious diseases such as HIV, hepatitis A, B or C
• Non-gastrointestinal malignancy
• Dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
• Comorbidities such as metabolic syndrome, autoimmune diseases, allergies
• Chronic pain syndromes (eg. chronic fatigue syndrome, fibromyalgia)
• Severe or morbid obesity
• Use of immunosuppressive or chemotherapy agents
• Antimicrobial treatment or prophylaxis within the last 6 months
• Females who are pregnant or breast-feeding
• Known clinically significant abnormal laboratory values
• Participation in high-risk sexual behaviors
• Abuse of alcohol or drugs
• Tattoo or body piercing within the last 6 months
• Travel to areas with endemic diarrhea during the last 3 months
• Positive stool testing for C. difficile toxin, ova, parasites, Giarda antigen, cryptosporidium antigen