Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying Time in Infants With Colic

  • STATUS
    Recruiting
  • End date
    Aug 31, 2024
  • participants needed
    120
  • sponsor
    BioGaia AB
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Updated on 4 October 2022
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infantile colic

Summary

This is a double-blind, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying time.

Description

Prevalence of infantile colic varies according to the definition used but estimates range between 5 % and 26 % of the infant population. To differentiate colic from other, more serious conditions it should be characterized by several clinical features. Infant colic is often accompanied by flushing the face, frown, tensing of the abdomen, clenching of the fists, and drawing up the leg, frequent, prolonged, and intense crying or fussiness in a healthy infant. Even though infant colic is benign and usually self-limiting condition it is a source of major distress for the infant, parents, family, and health care givers.

Despite infant colic occurs frequently, little agreement has been reached on the definition, pathogenesis, or the optimal management strategy for infant colic. Recent systematic reviews and meta-analyses showed that probiotic L. reuteri DSM 17938 supplementation significantly lowered the number of hours of crying and fussing daily. A significant peak effect was seen at 3 weeks in most studies. Interestingly, babies with infant colic were found to have increased evidence of gut inflammation, as evidenced by high levels of the antimicrobial peptide fecal calprotectin; also, the levels of fecal calprotectin declined significantly as the condition resolved.

Details
Condition Colic, Infantile
Treatment Placebo, L. reuteri
Clinical Study IdentifierNCT05512234
SponsorBioGaia AB
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Aged between 3-8 weeks at screening
Gestational age 37 weeks - 41 weeks at birth
Birth weight appropriate for gestational age (AGA - weight between 10th and 90th percentile) or Large for Gestational Age (LGA - weight above the 90th percentile) determined using WHO Weight-for Age percentile guides
No birth trauma and non-syndromic
Exclusively or predominantly breastfed infants (> 50 % breast fed)
Willing to maintain current feeding patterns (not change formula/not change ratio of formula:breast milk etc.)
Readiness and the opportunity for parents to fill out a study diary, questionnaires
Infantile colic diagnosed according to Rome IV criteria (face-to-face consult with a physician, parents have to report that their infant has cried or fussed for 3 or more hours per day, during 3 or more days in the preceding week). At Visit 2, this will be confirmed by Baby's Day Diary®, at least one 24 hour period should show 3 or more hours of crying/fussing time
Parent/caregiver with ability to understand and comply with the requirements of the study, as judged by the Investigator
Parent/caregiver willing and able to give informed consent for their and their infant's participation in the study
The mother of the infant must be willing to attend Visit 2 (Day 0), Visit 4 (Day 7), and Visit 6 (Day 21) and complete the study questionnaires
Infant is considered healthy, following physical exam

Exclusion Criteria

Infants with severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk > 8 times daily, projectile, bilious or bloody emesis)
Infants with failure to thrive, intrauterine growth retardation, haematochezia (blood in the stools), diarrhoea (watery stools that takes the shape of a container > 12x in breastfed and >5 in partially breastfed infants daily), or fever (38.0 degrees), as reported by parents
Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, and those with liver disease
Infants with reported exposure to probiotics in the previous 8 weeks (since birth)
Infants with reported exposure to antibiotics in the previous 8 weeks (since birth)
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