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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT01058356
Eligibility Criteria:
Inclusion Criteria:
* Male or female over 18
* Patients with respiratory tract infection who are receiving an oral or injection antibiotics.
* Signed informed consent form prior to inclusion in the study.
* Patients who begin receiving antibiotics within 48 hours before enrollment in this study.
Exclusion Criteria:
* Diagnosed Clostridium difficile colitis within the last 3 months
* Patients with tube feeding, ileostomy or colostomy
* Patients with basal diarrheal disease; acute enteritis, chronic diarrhea such as inflammatory bowel disease (IBD) etc, radiation enteritis, ischemic colitis and diarrhea caused by carcinoids etc.
* Patients receiving other probiotics during the last 15 days
* Patients treated with immunosuppressant drugs or immune deficiency patients
* Patients with radiotherapy and chemotherapy treatment for cancer.
* Patients treated with antidiarrheal, antispasmodic or motility agents for other diseases.
* Pregnant/Lactating women
* Patients with gastrointestinal (GI) surgery during the last 3 months.
* A history of hypersensitivity to cephalosporins, penicillin or clavulanic acid.
* Patients with verified diabetic autonomic neuropathy.
* Patients with organ transplants.
* Patients with underlying conditions or diseases which, in the opinion of the investigator, are unsuitable for inclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01058356
Study Brief:
Protocol Section:
NCT01058356