ISRCTN92431452Completed未知
The efficacy of three weeks’ daily supplementation with two-combined probiotic strains on infant colic
Angel Children’s Hospital0 sites112 target enrollmentStarted: December 10, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 112
Study Overview
Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34568236/ (added 28/09/2021)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Crying or fussing episodes lasting more than 3 hours per day and occurring at least 3 days per week within 7 days prior to enrollment (ROME IV criteria)
- •2. Less than 3 months (12 weeks) of age
- •3. Equal to or greater than 37 weeks of gestation at birth
- •4. Vaginal delivery
- •5. Birth weight of more than 2500g
- •6. Provided voluntary written informed consent from parents of the infant
Exclusion Criteria
- •1. Average weight gain < 100 grams/week from birth to the last recorded weight
- •2. Major medical problems (e.g. immunocompromised disease, major developmental or genetic abnormality)
- •3. Gastrointestinal disorder
- •4. Taking antibiotics four weeks prior to enrollment
- •5. Using the same probiotic strains in this study two weeks prior to enrollment
- •6. Taking antibiotics during the intervention
Investigators
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