NCT02839239

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

December 9, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2018

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

1.1 years

First QC Date

July 18, 2016

Last Update Submit

January 17, 2018

Conditions

Infant Colic

Outcome Measures

Primary Outcomes (1)

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

    Change in mean cry/fuss time

    28 days

Secondary Outcomes (5)

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

    28 days

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

    28 days

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

    7, 14, 21, 28 days

  • 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);

    7, 14, 21, 28 days

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

    7, 14, 21, 28 days

Other Outcomes (2)

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

    7, 14, 21, 28 days

  • Change in maternal depression score from day 0 through day 28

    28 days

Study Arms (2)

Drops with lactobacilli and vitamin D3

EXPERIMENTAL

Exclusive breast feeding plus L. rhamnosus 19070-2 and L. reuteri DSM 12246 in a dose of 125 x 106 CFU (both strains) with 1,667 mg fructooligosaccharides and 2,5 mcg (100 IU) vitamin D3 (in sunflower oil) per 6 drops. One dose (6 drops) in the first morning (from 6 AM) breastfeeding, and one dose (6 drops) in one of the evening (6 PM-12 PM) breast feedings for 28 days.

Dietary Supplement: Drops with lactobacilli and vitamin D3

Drops with vitamin D3

PLACEBO COMPARATOR

Exclusive breast feeding plus 2.5 mcg (100 IU) vitamin D3 (in sunflower oil) per 6 drops. One dose (6 drops) in the first morning (from 6 AM) breastfeeding, and one dose (6 drops) in one of the evening (6 PM-12 PM) breast feedings for 28 days.

Dietary Supplement: Drops with vitamin D3

Interventions

Drops with lactobacilli and vitamin D3DIETARY_SUPPLEMENT

Oil suspension with lactobacilli and vitamin D3

Drops with lactobacilli and vitamin D3
Drops with vitamin D3DIETARY_SUPPLEMENT

Oil suspension with vitamin D3

Drops with vitamin D3

Eligibility Criteria

Age4 Weeks - 12 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colic

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Soren Thomsen

    Biocare Copenhagen A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2016

First Posted

July 20, 2016

Study Start

December 9, 2016

Primary Completion

January 15, 2018

Study Completion

January 15, 2018

Last Updated

January 18, 2018

Record last verified: 2018-01