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Completed

NCT Number: NCT03467334

Infant Colic Treatment With Probiotics

This study evaluates the efficacy of Bifidobacterium breve CECT7263 and the mixture B. breve CECT7263/Lactobacillus fermentum CECT5716 in the treatment of infant colic. Group 1 will receive B. breve CECT7263 (2x10E8 CFU/day) one dose per day, group 2 will receive B. breve CECT7263 (1x10E8 CFU/day) and L. fermentum CECT5716 (1x10E8 CFU/day) in one dose per day, group 3 (control group) will receive simethicone 20 mg 4 times a day.

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Key information

Conditions

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

Age range

3 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Servicio Andaluz de Salud

Granada, 10012, Spain

About this study

Infant colic affects between 3-40% depending on the different criteria used for diagnosis. Recent studies carried out in healthy infants have shown that the consumption of B. breve CECT7263 and L. fermentum CECT5716 during the first months of life are related to a lower risk to present episodes of crying characteristic of infantile colic.

The objective of the present study is to compare the effect of B. brevis and B. brevis\\L mixture. fermentum with respect to simethicone.

It is a multicenter, controlled, randomized, blind, parallel-group, 4-weeks nutritional intervention study which will be conducted in 18 public and private hospitals and health centers from Spain.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Infants from 3 to 12 weeks of age
  • Born at least at week 34
  • Birth weight equal to or greater than 2000 grams
  • Fulfill the criteria of Rome III
  • Informed consent signed by parents or guardians

Exclusion criteria

  • Failure to thrive
  • Antibiotic treatment less than 2 weeks before the study or during the study
  • Take probiotics as a treatment, different from the one that could contain the powdered infant formula
  • Abandon breastfeeding and switch to infant formula
  • Failure to comply with the study protocol

Treatment and study plan

B. breve

Dietary Supplement

Bifidobacterium probiotic strain at 1E+08 cfu/day

B. breve plus L. fermentum

Dietary Supplement

Probiotic combination at 2E+08 cfu/day

Simethicone 20 MG

Drug

Standard treatment for infant colic

Primary outcomes

  1. Crying time

    Time frame: 4 weeks

    Crying time in minutes per day

Secondary outcomes

  1. Responders to treatment on weeks 1, 2, 3 and 4

    Time frame: 4 weeks

    Number of responders to the treatment in each group on weeks 1, 2, 3 and 4. It is understood that responders are those infants who have experienced a daily decrease in the duration of the crises cries 50% above baseline

  2. Gut microbiota

    Time frame: 4 weeks

    Effect of the treatment on intestinal microbiota: the levels of Escherichia coli, Clostridium, Bacteroides, Lactobacillus and Bifidobacterium at the beginning and at the end of the study (weeks 0 and 4) will be analyzed by quantitative PCR.

  3. Stool carbohydrates

    Time frame: 4 weeks

    Stool carbohydrate levels: lactose and other carbohydrate levels will be analyzed by chromatography (Triple Quad LC/MS) at the beginning and end of the study (weeks 0 and 4).

Sponsors and collaborators

Lead sponsor

Mónica Olivares Martín; PhD

Industry

Collaborators

  • European Regional Development Fund
  • Ministerio de Ciencia e Innovación, Spain

Registry information

Official study title

Nutritional Intervention, Multicenter, Randomized, Blind, Parallel Groups Study to Assess the Effect of Consumption of Bifidobacterium Breve CECT7263 and Lactobacillus Fermentum CECT5716 on Infant Colic

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 16, 2018
Registry last updated
Jul 23, 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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