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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07360535
Eligibility Criteria:
Inclusion Criteria:
* According to the diagnostic criteria of Rome IV, the following symptoms include at least 2 and last for at least 1 month:
1. Defecation \<= 2 times per week;
2. have a history of fecal retention;
3. There is a history of pain or difficulty in defecation;
4. There is a history of expelling large pieces of feces;
5. There is a large fecal mass in the rectum. At least 1 episode of incontinence per week after self-control of bowel movements; passing large pieces of stool that may clog the toilet;
* Term infants, gestational age from 37 to 42 weeks;
* Birth weight between 2500 - 4000g;
* 0-3 years old;
* Parents voluntarily defer major changes in infant feeding practices;
* Parents are willing and able to fill in diaries and questionnaires
Exclusion Criteria:
* Chronic diseases or major medical problems;
* Gastrointestinal organic diseases;
* Growth retardation;
* The mother or child of the breastfeeding child used antibiotics within 2 weeks before randomization and during the trial;
* Infants (in formula and/or supplements) or their mothers used probiotics within 2 weeks before randomization and during the trial;
* Has participated in other clinical trials;
* Food allergies cause constipation (such as milk, eggs and other foods)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
3 Years
Study:
NCT07360535
Study Brief:
Protocol Section:
NCT07360535