Status:
COMPLETED
The Effect of Probiotic Added to Maternal Diet on Infantile Colic and Intestinal Microbiota Content
Lead Sponsor:
Halic University
Collaborating Sponsors:
Istanbul University - Cerrahpasa
Conditions:
Infantile Colic
Microbial Colonization
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
This study aims to investigate the effect of probiotic added to the diet of mothers on infantile colic in the postpartum period and the content of the neonatal intestinal microbiota.
Detailed Description
Infantile colic, by definition, is defined as excessive crying in the afternoon or evening, with no specific reason, starting at the first weeks of newborn life, lasting at least 3 weeks, longer than ...
Eligibility Criteria
Inclusion
- Mother's ability to speak Turkish,
- Single pregnancy,
- Delivery time is between 37 \<GH \<42 weeks,
- The mother does not have a chronic disease,
- Vaginal birth,
- The mother's not using antibiotic drugs during pregnancy and postpartum period,
- Neonatal diagnosis of infantile colic,
- Scoring 10 points below the Beck Depression Inventory,
- Smoking of the woman during pregnancy and postpartum period,
- The absence of Intrauterine Growth Retardation (IUGR) or genetic disease in the newborn,
- Birth weight is in the range of 2500-4000 gr.
- No gastrointestinal disease in the newborn,
- 50% of the newborn is feeding on breast milk,
- No more than 24 hours of Early Membrane Rupture (EMR) at birth.
Exclusion
- Having problems with the breast in the mother,
- The mother is using probiotics / antibiotics before randomization and during her pregnancy,
- Mothers who are included in the study sample, take part in other clinical studies at the same time.
Key Trial Info
Start Date :
October 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04374955
Start Date
October 7 2020
End Date
June 1 2021
Last Update
June 7 2021
Active Locations (1)
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1
Haseki Eğitim ve Araştırma Hastanesi
Istanbul, Sultangazi, Turkey (Türkiye), 34096