Status:
WITHDRAWN
The Effect of Probiotics on Symptoms of Infantile Colic
Lead Sponsor:
Lallemand Health Solutions
Collaborating Sponsors:
ProbiSearch SL
Conditions:
Colic
Eligibility:
All Genders
Up to 8 years
Phase:
PHASE2
Brief Summary
The aim of this study is to evaluate the effects of a probiotic formulation on the daily crying patterns of infants. It is hypothesized that participants given the probiotic formulation will show a si...
Detailed Description
Participants diagnosed with symptoms of infantile colic will be recruited to participate in this randomized, double-blind, placebo-controlled, two-arm parallel study. Eligible participants will be enr...
Eligibility Criteria
Inclusion
- Healthy male or female.
- Age ≤ 8 weeks old.
- Diagnosis of infantile colic according to the Rome IV criteria. Infants must show cry or fuss behaviour for 3 or more hours per day, during 3 or more days in 7 days.
- Exclusively breastfeeding and planning to breastfeed for duration of study.
- With a written informed consent signed by the father, mother, or legal guardian, and with expressed or implied consent of the other parent.
- With parents willing to complete questionnaires, records, and diaries associated to the study and to complete all clinical visits and telephone calls.
Exclusion
- Birthweight \< 2500 g.
- Gestational age \< 37 weeks.
- Apgar score at 5 minutes \< 7.
- Partially or fully formula fed infants, with the exception of the first 4 days after birth.
- Stunted growth/weight loss (\< 100 g/week from birth to last reported).
- Gastroesophageal reflux disease, short bowel syndrome, chronic intestinal diseases or gastrointestinal malformations.
- Fever and/or infectious diseases, or current systemic infections, or history of congenital infections.
- Genetic diseases and chromosomal abnormalities.
- Metabolic diseases or pancreatic insufficiency.
- Immunodeficiency.
- Neurological diseases.
- Suspected or confirmed food allergies and intolerances.
- Use of probiotics, prebiotics, antibiotics, or gastric acid inhibitors by the infant at any time from birth to the moment of screening.
- Use of anti-colic medication at any time from birth to the moment of screening.
- Use of probiotic supplements by the mother between the birth of their infant and the moment of screening.
- Currently enrolled in another clinical study or having participated in another clinical trial from birth to the moment of screening.
Key Trial Info
Start Date :
February 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05198700
Start Date
February 8 2022
End Date
February 1 2024
Last Update
July 3 2023
Active Locations (5)
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1
Centro de Salud Cerro del Aire
Majadahonda, Madrid, Spain, 28220
2
Centro de Salud Ibiza
Madrid, Spain, 28009
3
Hospital Vithas La Milagrosa
Madrid, Spain, 28010
4
Centro de Salud Campo de la Paloma
Madrid, Spain, 28018