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Recruiting NCT07190859

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

No phase Interventional Infantile Colic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: L. reuteri, Placebo.
Who it may be relevant to
Registry conditions: Infantile Colic. Basic parameters: 3 Weeks — 12 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Bulgaria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Double-blind, Randomised, Placebo-controlled, Parallel-group Study Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic

Overview

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

Interventions

  • Dietary supplement L. reuteri
    Supplementation with drops containing L. reuteri once daily for 21 consecutive days
  • Dietary supplement Placebo
    Supplementation with identical drops without L. reuteri once daily for 21 consecutive days

Primary outcome measures

  • Crying and fussing time [Time frame: From baseline to Day 7]
Secondary outcome measures (5)
  • Crying and fussing time [Time frame: From baseline up to Day 21]
  • Number of responders [Time frame: From baseline up to Day 21]
  • Family Quality of Life [Time frame: From baseline up to Day 21]
  • Sleeping time [Time frame: From baseline up to Day 21]
  • Maternal depression [Time frame: From baseline up to Day 21]

Eligibility criteria

Inclusion criteria

  • Aged between 3-12 weeks at screening.
  • Gestational age 37+0 weeks - 42+0 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.
  • Parents/caregivers/legal guardians are >18 years.
  • 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/caregivers/legal guardians to fill out a study diary, questionnaires.
  • Infantile colic diagnosed according to Rome IV criteria (face-to-face consult with a physician, parents/caregivers/legal guardians must 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.
  • Parents/caregivers/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator.
  • Parents/caregivers/legal guardians 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 3 (Day 8), and Visit 4 (Day 22).
  • Infant is considered healthy, in the opinion of the investigator 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/caregivers/ legal guardians.
  • Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, and those with liver disease.
  • Infants with reported exposure to probiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
  • Infants with reported exposure to oral and/or systemic antibiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
  • Infants with reported exposure to medications, therapies, or products with the aim to relieve infantile colic including proton pump inhibitors in the 7 days prior to Screening Visit (V1) and throughout the study period.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Bulgaria · 4 centers
  • UMHAT Deva Maria — Burgas
  • Medical Centre Asklepiy OOD — Dupnitsa
  • AIPSMP — Stara Zagora
  • Ipsmp Eood — Stara Zagora

Identifiers

NCT: NCT07190859 · CSUB0218

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗