Clinical Trials

Inclusion Criteria - DGBI group:

• Signed written informed consent
• Male or female ≥ 18 years of age
• Clinical suspicion of at least one DGBI (overlapping DGBI accepted)
• Ability to understand and willingness to comply to the study procedures; ability to complete questionnaires in the local language (or in a language where all the questionnaires are available)

Inclusion Criteria - healthy volunteers:

• Signed written informed consent
• Age ≥ 18 years
• No ongoing gastrointestinal symptoms that occur more than “rarely”

Exclusion Criteria - DGBI group:  

• Abnormal results on the screening laboratory tests (based on clinical judgment by the local PI, clinically relevant for study participation)
• Other gastrointestinal disease(s) that explain the patient's symptoms, as judged by the investigator
• Other severe disease(s) such as malignancy, severe heart disease, kidney disease or neurological disease
• History of documented drug or alcohol abuse disorder within 6 months before inclusion
• Consumption of antibiotics 1 month before inclusion (only relevant if fecal samples for microbiota analyses are collected). 
• Other drugs interfering with proper symptom assessment or explaining symptoms of the patient according to the judgement of the PI (all ongoing medications, including regular use of pre- and probiotics will be recorded in the RFRI phenotyping tool).
• History of bowel resection, abdominal radiation.

Exclusion Criteria - healthy volunteers:

• Responses more than rarely to any of the GI symptom questions on the screening questionnaire
• History of chronic diarrheal disorder, IBS, any confirmed or clinically suspected DGBI, peptic ulcer disease, diverticulitis, inflammatory bowel disease, microscopic colitis, celiac disease
• Known GI malignancy or 1st degree family member with GI cancer
• Episode of diagnosed or suspected gastroenteritis in the past 1 year
• History of bowel resection, abdominal radiation

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/31/23. Questions regarding updates should be directed to the study team contact