The Effect of Probiotics on Symptoms of Infantile Colic (PROCOLIN)

  • STATUS
    Recruiting
  • End date
    Apr 12, 2023
  • participants needed
    70
  • sponsor
    Lallemand Health Solutions
Updated on 12 March 2022
infantile colic

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 significant reduction in daily crying duration compared to participants receiving the placebo.

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 enrolled in this study for 6 weeks, and will undergo a 1-week run-in baseline period followed by a 4-week interventional period, then a 1-week follow-up period.

The study will consist of 7 visits (V0 to V6): 4 in-person visits that alternate with 3 phone calls.

Details
Condition Colic
Treatment Placebo, Probiotic formulation
Clinical Study IdentifierNCT05198700
SponsorLallemand Health Solutions
Last Modified on12 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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