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:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT01824667
Eligibility Criteria:
Inclusion Criteria:
1. Aged between 18 and 65 years old.
2. Presence of bloated feeling or experiencing abdominal fullness, with or without visible distention, often in the last 12 months.
3. Ability to communicate well with the investigator and to comply with the requirements of the entire study.
4. Volunteer has given written informed consent to participate and is willing to participate in the entire study.
Exclusion Criteria:
1. History or evidence of organic disease of the gastrointestinal tract; such as tumour, irritable bowel syndrome, etc., within the previous 5 years.
2. Undergone surgical resection of any part of the bowel.
3. History of malignancy within the previous 5 years (with exception of well-treated basal cell carcinoma or in situ cervical carcinoma).
4. Received antibiotics in the previous four weeks.
5. Consumed probiotic or prebiotic preparations on a regular basis (at least 3 times per week) in the last 2 weeks.
6. Former participation in another study involving prebiotic or probiotic preparations or investigational drugs within the previous one month, or intention to use such drugs during the course of the study.
7. Severe allergy or any history of severe abnormal drug reaction, drug or alcohol abuse.
8. Regular use of any medication with exception of hormonal replacement therapy and contraception.
9. Women who are pregnant or breast-feeding.
10. Fertile women not practicing a medically-approved method of contraception.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01824667
Study Brief:
Protocol Section:
NCT01824667