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Completed

NCT Number: NCT02839239

Lactocare Baby Drops in Infants Colic

The objective of this study is to determine an efficacy of the combination of L. rhamnosus 19070-2 (FloraActiveTM) and L. reuteri DSM 122460 (FloraActiveTM) in decreasing cry/fuss in infants aged 4 through 12 weeks with IC. The active group of infants will receive lactobacilli with vitamin D3 while the control group will receive vitamin D3 2 times daily as oil suspension for 28 days. Duration of infant fuss/cry will be measured at baseline and at the end of intervention to define a difference between the groups

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Key information

Age range

4 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

There is accumulating interest in role of lactobacilli in decreasing cry and fuss in infant colic, the condition that affects around 1 of 4-5 infants. The interest for dietary supplementation has been evoked by a line of earlier studies, indicating that infants with colic had an increased number of gas-forming E.coli in the intestines and potential interference between lactobacilli and E.coli. Systematic review of evidence, based on the 6 randomized controlled dietary studies, conducted in Italy, Poland, Australia, Canada, and Finland, has concluded of the decrease of the mean time cry of infant by -55 minutes a day after the 3 weeks dietary course with lactobacilli . In the mentioned studies most commonly used lactobacilli were L. reuteri, however, the effect of combination of L. reuteri with other lactobacilli remains unknown.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent form signed by both parents.
  • Gender: males and females;
  • Age: 4 -12 weeks;
  • Infant colic, defined as cry/fussing lasting > 3 h, occurring > 3 d for 7 days;
  • Gestational age 37-42 weeks;
  • Birth weight 2,500-4,200 g;
  • Stated availability throughout the study period;
  • Sated availability of mobile phone or phone with answering machine.

Exclusion criteria

  • Any formula feeding in any amount;
  • Failure to thrive (weight gain less than 100 grams per week as averaged from the birth weight to the weight at entry);
  • Current maternal smoking;
  • Known moderate or severe disease of any systems (neural, skeletal, muscular, cutaneous, gastrointestinal, respiratory, genital, urinary, immune);
  • Present intake of antibiotics by infant or mother;
  • Present intake of prebiotics or probiotics by infant or mother;
  • Difficulty of parents to comprehend study requirements as judged by the physician;
  • Suspected parental alcohol or drug addiction as judged by the physician.

Treatment and study plan

Drops with lactobacilli and vitamin D3

Dietary Supplement

Oil suspension with lactobacilli and vitamin D3

Drops with vitamin D3

Dietary Supplement

Oil suspension with vitamin D3

Primary outcomes

  1. Change in mean cry/fuss time (min/day) from day 0 through day 28

    Time frame: 28 days

    Change in mean cry/fuss time

Secondary outcomes

  1. Change in mean cry time (min/day) from day 0 through day 28

    Time frame: 28 days

    Change in mean cry time

  2. Change in mean fuss time (min/day) from day 0 through day 28

    Time frame: 28 days

    Change in mean fuss time

  3. Treatment success (percent) at 7, 14, 21, 28 days, defined as more than 25% and 50% reduction in cry time from baseline

    Time frame: 7, 14, 21, 28 days

    Outcome Measure Description

  4. Recovery success (percent) at 7, 14, 21, 28 days, defined as reduction in duration of cry time less than 3 hours per day (unmet Wessel criteria);

    Time frame: 7, 14, 21, 28 days

    Recovery success

  5. Cry and fuss time (min/day) on days 0, 7, 14, 21, 28

    Time frame: 7, 14, 21, 28 days

    Cry and fuss time

Other outcomes

  1. Infant sleep duration (min/day) on days 0, 7, 14, 21, 28

    Time frame: 7, 14, 21, 28 days

    Infant sleep duration

  2. Change in maternal depression score from day 0 through day 28

    Time frame: 28 days

    Change in maternal depression score

Sponsors and collaborators

Lead sponsor

Biocare Copenhagen A/S

Industry

Collaborators

  • Lviv National Medical University

Registry information

Official study title

Role of Lactobacillus Rhamnosus (FloraActive™) 19070 and Lactobacillus Reuteri (FloraActive™) DSM 12246 in Infant Colic: a Controlled Dietary Study

Acronym: LACONIC

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 20, 2016
Registry last updated
Jan 18, 2018

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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