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 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT01609751
Eligibility Criteria:
Inclusion Criteria:
1. A history of two episodes of UAD treated with antibiotics in the last five years.
2. Diverticulosis confirmed by colonoscopy, barium enema, USS, CT or MRI imaging or at surgery.
3. Agreement to consume one bottle of Yakult daily for 12 months
4. Availability of space in the domestic refrigerator for storage of Yakult units
5. Able to access depot (local primary care premises or chemist) to collect regular supplies of Yakult
6. Able to cope with keeping a diary etc.
7. Willing to take Yakult supplies and a cold bag on holiday to ensure as near as possible continuous daily doses (certainly never more than one week break as Lactobacilli casei will persist in the human gut for at least one week
8. Capable of giving informed consent
9. Aged ≥ 50 and ≤ 75 years at commencement of trial.
Exclusion Criteria:
1. Recent history of peptic ulcer
2. Chronic renal insufficiency
3. Ongoing or past major diverticulitis complications
4. Any serious debilitating illness (cancers, cardiovascular disease etc. but not DM)
5. Dementias or memory problems
6. Regular probiotic consumption over the past year.
7. Undergoing immunosuppressive therapy or treatment
8. Lactose intolerance or intolerance to dairy products
9. Immunosuppressed patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT01609751
Study Brief:
Protocol Section:
NCT01609751