Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
NCT ID:
NCT06518850
Eligibility Criteria:
Inclusion criteria:
Part 1 Clinical characteristics of small intestinal bacterial overgrowth in patients with abdominal distension of different etiologies
1. Age 18-60 years old and gender;
2. The chief complaint is abdominal distension and/or abdominal distension, abdominal distension and/or abdominal distension more prominent than other symptoms.
Part 2 Efficacy observation of functional abdominal distention combined with small intestine bacterial overgrowth
1. Patients with functional abdominal distension and small intestinal bacterial overgrowth were selected in Part 1;
2. No drug contraindications.
Exclusion criteria:
Part 1 Clinical characteristics of small intestinal bacterial overgrowth in patients with abdominal distension of different etiologies
1. Preparation for pregnancy, pregnancy, breastfeeding women, or overall poor compliance, or other conditions that the investigator believes need to be excluded;
2. History of malignant tumors, history of abdominal surgeries;
3. Food intolerance, confirmed or suspected lactose intolerance;
4. Diagnosis of urinary system (chronic kidney disease, etc.), immune system (scleroderma, etc.), nervous system (Parkinson's disease, etc.), mental system (depression, etc.) and other diseases outside the digestive system;
5. Antibiotics and microecological preparations should be used within two weeks. Use motility enhancers, secretagogues, antifoaming agents, spasmolytics, opioids, antidepressants and other medications within a week.
Part 2 Efficacy observation of functional abdominal distention combined with small intestine bacterial overgrowth
1. Antibiotics and microecological preparations should be used within two weeks;
2. Use motility enhancers, secretagogues, antifoaming agents, spasmolytics, opioids, antidepressants and other medications within a week.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06518850
Study Brief:
Protocol Section:
NCT06518850