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 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT01599156
Eligibility Criteria:
Inclusion Criteria:
* Age of 18-55 years
* Fewer than three SBMs per week (occurring without the use of a laxative, enema, or suppository within the preceding 24 hours)
* One or more of the following symptoms/signs during more than 25% of bowel movements for at least 12 weeks within the preceding 12 months:(1)straining, lumpy or (2) hard stools, and (3)a sensation of incomplete evacuation Six or fewer SBMs/week and fewer than three complete CSBMs/week during the 14-day baseline period.
* Ability to comply with the study guidelines
Exclusion Criteria:
* Loose or watery stool in the absence of laxative use for more than 25% of bowel movements during the 12 weeks preceding the trials.
* Mushy stool defined as a score of 6 on the Bristol Stool Form Scale for any SBM during the baseline period.
* Rome III criteria for the irritable bowel syndrome.
* History of pelvic-floor dysfunction.
* Neurological pathologies
* Psychiatric conditions
* Chronic use of medication with a GI-activity.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01599156
Study Brief:
Protocol Section:
NCT01599156