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 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT03596905
Eligibility Criteria:
INCLUSION CRITERIA
A patient will be eligible for study participation if he or she meets all of the following criteria:
1. Male or female child aged 6 to \< 18;
2. Meets ROME IV criteria for child/adolescent IBS-C
3. Patient's parent/guardian/LAR is able to voluntarily provide written, signed, and dated consent and patient is able to voluntarily provide assent as per IRB guidance;
4. Patient and patient's parent/guardian/LAR demonstrates an understanding, ability, and willingness to fully comply with study procedures
EXCLUSION CRITERIA
A patient will be excluded from the study if he or she meets any of the following criteria:
1. The patient has a mental age \<4 years in the investigator's opinion;
2. The patient has previously been diagnosed with anorectal malformations, neurological deficits, or anatomical anomalies that would constitute a predisposition to constipation;
3. The patient is pregnant or lactating;
4. The patient's mobility or normal exercise tolerance is compromised in the investigator's opinion;
5. The patient has been screened for or participated in another Synergy study in the past;
6. The patient has a sibling that is currently participating or has participated in another Synergy study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT03596905
Study Brief:
Protocol Section:
NCT03596905