Phase
Condition
Colic
Gastrointestinal Diseases And Disorders
Lactose Intolerance
Treatment
N/AClinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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
Exclusion
Exclusion Criteria:
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, herniarepair, 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 asthmaagents, blood pressure and cholesterol lowering agents, proton pump inhibitors andnon-prescription medicines
Abnormal screening biochemistry
Abnormal colonoscopy findings
Pregnant, planned pregnancy or breastfeeding females
Ingestion of probiotics or antibiotics < 8 weeks before the inclusion Inclusion criteria for donors
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 FormScale)
No medication consumption Exclusion criteria for donors
Known or high risk of infectious diseases such as HIV, hepatitis A, B or C
Positive stool sample for C. difficile toxin, parasites or other pathogens
Antibiotic treatment in the past 6 months
Abuse of alcohol or drugs
Smoking
Tattoo or body piercing within the last 6 months
Allergy, asthma or eczema
Family history of gastrointestinal diseases
Participation in high-risk sexual behaviors
Born by Caesarean section
Study Design
Study Description
Connect with a study center
Aleris Hamlet Hospitaler, København
Copenhagen, Søborg 2760
DenmarkSite Not Available

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