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NCT Number: NCT05271747

Prospective Study to Determine the Factors Influencing Infant Colic

Randomized study to determine the effect of a commercialized combination of 2 probiotic strains (Bifidobacterium Longum and Pediococcus pentosaceus) and the impact of feeding type in babies diagnosed with colic under Roma IV criteria when administered for 21 days.

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Key information

Conditions

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

Age range

2 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Medica Sur, room 108, tower 2, Mexico City, Mexico

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About this study

Randomized, single-blind, interventional study with two parallel groups to determine the effect of two different commercialized probiotic products (Lactobacillus reuteri or a combination of two different strains (Bifidobacterium longum and Pediococcus pentosaceus)) and the impact of feeding type in babies diagnosed with colic under Roma IV criteria. Infants meeting selection criteria are randomized 1:1 and stratified according to the type of feeding (breastfed or formula).

Probiotics are administered once a day (5 drops) for 21 days. Parents must document clinical parameters during this 21 days. This parameters include colic-related symptoms, other functional gastrointestinal disorders symptoms, parental anxiety and adverse events.

Moreoever, stool samples are collected to determine intestinal microbiota and calprotectin levels.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy infants from 2 to 12 weeks of age
  • Infants diagnosed with infant colic following Roma IV criteria for clinical research
  • Gestational age greater or equal to 37 weeks
  • Birth weight greater than 2100 g
  • Exclusively breastfed or formula fed with a maximum of one daily intake of breast milk.

Exclusion criteria

  • Infants that are fed with solid food.
  • Infants whose parents can not appropriately follow the requirements of the study.
  • Antibiotics or probiotics administration to the infant (including infant formula with probiotics) 2 weeks prior the inclusion in the study.
  • Breastfed infants whose mothers have taken antibiotics and/or probiotics 2 weeks prior the inclusion in the study.
  • Infants fed extensively hydrolyzed infant formula
  • Specific medication use for the treatment of functional digestive disorder: antacids (IBP type or H2 blockers), laxative Polyethylene glycol (8PEG), lactulose, magnesia), lactase or simeticone.
  • Infants going through therapies related with acupuncture, homeopathy, medicinal herbs, or taking anti-inflammatory or antispasmodic drugs.

Treatment and study plan

AB-Kolicare

Dietary Supplement

Probiotic multi-strain formulation containing Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8330 for 21 days, 5 drops/day preferably during the first intake of milk

Reuteri gotas

Dietary Supplement

Probiotic single-strain formulation containing Lactobacillus reuteri DSM17938 for 21 days, 5 drops/day before or after any daily meal.

Primary outcomes

  1. Duration of crying and fussing

    Time frame: 21 days

    Change on daily crying and fussing minutes measured through Barr ( Barr et al., 1988).validated crying and fussing scale. The Barr scale consists of a 24 hours dairy where parents paint number of hours crying and fussing every day. Results show the number of hours of crying and fussing per day.

  2. Percent of responders

    Time frame: 7, 14, 21 days

    Percent of subjects whose change in crying time is equal or larger than 50% from baseline

Secondary outcomes

  1. Number of regurgitations

    Time frame: 21 days

    Change in daily number of regurgitations

  2. Bowel movements

    Time frame: 21 days

    Change in daily number of bowel movements

  3. Food intake

    Time frame: 21 days

    Frequency of food intake

  4. Parent's anxiety and depression

    Time frame: baseline, day 21

    Change in parent's anxiety and depression score measured through Hospital Anxiety and Depression Scale (HADS). The HADS questionnaire has 7 items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.

  5. Fecal microbiome

    Time frame: baseline, day 21

    Changes on fecal microbiome evaluated by RNA ribosomal 16S genes analysis

  6. Fecal calprotectin

    Time frame: baseline, day 21

    Change on calprotectin in feces

  7. Adverse events

    Time frame: 21 days

    Frequency of adverse events reported on dairy report form after randomization and until day 21

Sponsors and collaborators

Lead sponsor

AB Biotics, SA

Industry

Registry information

Official study title

Prospective Study to Determine the Factors Influencing Infant Colic Course in Infants Taking Probiotics

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 9, 2022
Registry last updated
Feb 24, 2026

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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