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Completed

NCT Number: NCT02988791

Evaluation of a Probiotic (Bifidobacterium in the Treatment of Infantile Colic (IC)

Infantile colic (IC) criteria includes all of the following in subjects aged ≤ 4 months: paroxysms of irritability, fussing, or crying that start and stop without obvious cause; episodes lasting 3 or more hours per day and occurring at least 3 days per week for at least 1 week; and no failure to thrive. The condition is very common in the first 4 months of life (10-30 % of infants) with a peak prevalence at 6-8 weeks and is characterized by excessive and inconsolable crying without an identifiable cause. Infantile colic cause considerable stress for the baby and the family, huge medical expenses (the IC cause 10-20 % of all pediatric visits in the first 4 months of life) and frequent formula changes.

The pathophysiology of IC is still poorly defined, but differences in gut microbiota composition seem to be involved. In particular, differences in the number and species of Lactobacilli spp, Klebsiella spp and Escherichia coli spp have been demonstrated in subjects with IC, and it has been postulated that these alterations could be responsible for an abnormal gas production within gut lumen resulting in distension and abdominal pain. These findings suggest the potential role of probiotics as preventive and therapeutic strategy for the IC.

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Key information

Conditions

Infantile Colic Colic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases

Age range

1 week–7 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Naples Federico II

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • exclusively breastfed healthy infants of both sex, aged ≤ 7 weeks;
  • Diagnosis of IC according to Rome III criteria
  • Written informed consent of the parent/tutor

Exclusion criteria

  • Birth weight<2500 g
  • Gestational age<37 weeks
  • APGAR 5 minutes <7
  • Formula feeding
  • Abnormal body growth/loss of weight (<100 g/weeks from birth to the last reported weight)
  • Neurological diseases
  • Known or suspected food allergy
  • Gastroesophageal reflux disease
  • Use of substances that alter gut microbiota (pre/pro/synbiotic, antibiotics, gastric acidity inhibitors) or any anti-colic drug in the last 2 weeks prior the enrollment
  • History of fever and/or infectious diseases in the last 2 weeks prior the enrollment
  • Ongoing systemic infections
  • History of congenital infections
  • Chronic intestinal diseases (cystic fibrosis or other forms of pancreatic insufficiency primitive)
  • Malformation of the gastrointestinal (such as esophageal atresia, intestinal atresia, short bowel syndrome, malrotation), urinary or respiratory tract
  • Metabolic diseases
  • Genetic diseases and chromosomal abnormalities
  • Primary or secondary immunodeficiencies
  • Not sufficient reliability or presence of conditions that may result in non-compliance/adherence of the patient to the Protocol
  • Previous participation in this study

Treatment and study plan

probiotic (BIfidobacterium, BB-12®)

Dietary Supplement

probiotic (Bifidobacterium, BB-12®)

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. mean daily crying duration

    Time frame: up to 28 days

    reduction of ≥50% of mean daily crying duration

Secondary outcomes

  1. number of regurgitation

    Time frame: up to 28 days

  2. Evaluation of the gut microbiota modifications

    Time frame: up to 28 days

    Stool sample

  3. fecal production of peptides from innate immune system

    Time frame: up to 28 days

    Stool sample

  4. fecal short chain fatty acids production

    Time frame: 28 days

    Stool sample

  5. evacuative frequency

    Time frame: up to 28 days

  6. consistency of the fecal mass

    Time frame: up to 28 days

    assessed by means of Bristol score

  7. number of crying episode

    Time frame: up to 28 days

  8. sleep

    Time frame: up to 28 days

    duration of sleep

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Collaborators

  • SOFAR S.p.A.

Registry information

Official study title

Randomized Clinical Trial to Evaluate the Efficacy of Bifidobacterium in the Treatment of Infantile Colic (IC)

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Dec 9, 2016
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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