Infant ColicLACONICNCT02839239
Lactocare Baby Drops in Infants Colic
A study testing Drops with lactobacilli and vitamin D3 and Drops with vitamin D3 in people with Infant Colic, run by Biocare Copenhagen A/S.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 weeks
- Conditions the study is for
- Infant Colic
- What is being tested?
- Drops with lactobacilli and vitamin D3 and Drops with vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- 9 Dec 2016to 15 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Role of Lactobacillus Rhamnosus (FloraActive™) 19070 and Lactobacillus Reuteri (FloraActive™) DSM 12246 in Infant Colic: a Controlled Dietary Study
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
Read the detailed description
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.
- Conditions
- Infant Colic
- Being tested
- Drops with lactobacilli and vitamin D3, Drops with vitamin D3
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drops with lactobacilli and vitamin D3Dietary supplement
Oil suspension with lactobacilli and vitamin D3
Drops with vitamin D3Dietary supplement
Oil suspension with vitamin D3
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Drops with vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean cry/fuss time (min/day) from day 0 through day 28
Change in mean cry/fuss time
Measured: 28 days
Secondary outcomes (5)
Change in mean cry time (min/day) from day 0 through day 28
Change in mean cry time
Measured: 28 days
Change in mean fuss time (min/day) from day 0 through day 28
Change in mean fuss time
Measured: 28 days
Treatment success (percent) at 7, 14, 21, 28 days, defined as more than 25% and 50% reduction in cry time from baseline
Outcome Measure Description
Measured: 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);
Recovery success
Measured: 7, 14, 21, 28 days
Cry and fuss time (min/day) on days 0, 7, 14, 21, 28
Cry and fuss time
Measured: 7, 14, 21, 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study start9 Dec 2016
- Primary completion15 Jan 2018
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant ColicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocare Copenhagen A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lviv National Medical University
- Responsible party
- Sponsor
- Investigators
- Soren Thomsen, Study director, Biocare Copenhagen A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839239
- Sponsor's protocol ID
- IC-SVG-P0001
- Acronym
- LACONIC
- Status last verified
- Jan 2018
- First submitted
- 18 Jul 2016
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Lactobacillus Rhamnosus (FloraActive™) 19070 and Lactobacillus Reuteri (FloraActive™) DSM 12246 in Infant Colic: a Controlled Dietary Study
- ClinicalTrials.gov ID
- NCT02839239
- Acronym / sponsor ID
- LACONIC / IC-SVG-P0001
- Conditions
- Infant Colic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Biocare Copenhagen A/SIndustry (pharma, biotech, devices)
- Collaborators
- Lviv National Medical University
- Study start
- 9 Dec 2016
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drops with lactobacilli and vitamin D3 | Experimental | Dietary Supplement: Drops with lactobacilli and vitamin D3Exclusive 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. |
| Drops with vitamin D3 | Placebo comparator | Dietary Supplement: Drops with vitamin D3Exclusive 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. |
Who may qualify
- Ages
- 4 to 12 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drops with lactobacilli and vitamin D3Oil suspension with lactobacilli and vitamin D3 | Dietary supplement | Drops with lactobacilli and vitamin D3 |
| Drops with vitamin D3Oil suspension with vitamin D3 | Dietary supplement | Drops with vitamin D3 |
Primary outcome
Change in mean cry/fuss time (min/day) from day 0 through day 28
Time frame: 28 days
Change in mean cry/fuss time
5 secondary outcomes
Change in mean cry time (min/day) from day 0 through day 28
Time frame: 28 days
Change in mean fuss time (min/day) from day 0 through day 28
Time frame: 28 days
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
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
Cry and fuss time (min/day) on days 0, 7, 14, 21, 28
Time frame: 7, 14, 21, 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soren Thomsen study director
Biocare Copenhagen A/S
Questions about this trial
What is this clinical trial studying?
A study testing Drops with lactobacilli and vitamin D3 and Drops with vitamin D3 in people with Infant Colic, run by Biocare Copenhagen A/S.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean cry/fuss time (min/day) from day 0 through day 28 (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.