ColicPhase 2NCT01541046
Lactobacillus Reuteri DSM 17938 Versus Placebo in the Treatment of Infantile Colic
A Phase 2 study testing Biogaia L. reuteri DSM 17938 in people with Colic, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Infantile colic is a common medical condition which remains a frustrating problem for parents and health care providers with no clear treatment guidelines. To fill the void in existing literature, we present a protocol to examine whether probiotics are effective in decreasing infantile colic symptoms when compared to… Read more about this study
- Who is it for?
- Ages 21 to 180 days
- Conditions the study is for
- Colic
- What is being tested?
- Biogaia L. reuteri DSM 17938
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to Jun 2014
- Phase
- Phase 2
- 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 21 to 180 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy term infant 21-90 days of age
- Birth weight ≥2500 g
- Exclusively breastfed (to reduce variability in the intestinal microflora attributable to dietary variations)
- With colic symptoms (>3 hours of crying on >3 days per week) with debut 10 ± 5 days before enrollment
- Gestational age between 37 and 42 weeks
- Apgar score higher than 7 at 5 minutes
- Written informed consent from a parent
Who cannot join
- Any chronic illness or gastrointestinal disorder as judged by the pediatrician
- Any history of antibiotic treatment or probiotic supplementation
- Failure to obtain a written consent by parent/legal guardian
- Participation in other clinical trials
- Infants with acute illness
- Subjects with allergies or family history of allergies to any of the ingredients of the study product or placebo
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lactobacillus Reuteri DSM 17938 Versus Placebo in the Treatment of Infantile Colic: A Randomized Double-blind Controlled Trial
Infantile colic is a common medical condition which remains a frustrating problem for parents and health care providers with no clear treatment guidelines. To fill the void in existing literature, we present a protocol to examine whether probiotics are effective in decreasing infantile colic symptoms when compared to placebo treatment.
We hypothesize that oral administration of the probiotic L. reuteri DSM 17938 will reduce symptoms of infantile colic in breastfed infants in comparison to placebo.
An interim analysis will be conducted after 50 infants randomized to monitor both safety and efficacy.
Read the detailed description
Infantile colic is one of the most commonly reported medical problems within the first three months of life causing appreciable distress for both parents and pediatricians. The reported incidence of infantile colic ranges from 3% to 28% in prospective studies and up to 40% in retrospective surveys.
The pathogenesis of infantile colic remains elusive despite decades of research. It appears that multiple independent origins might be involved: amongst them infant's difficult temperament, inadequate mother-infant communication or maternal anxiety, transient lactase deficiency, exposure to cow's milk, abnormal gastrointestinal function, maternal smoking during pregnancy or after delivery. Consequently, various treatment approaches have been tried to alleviate this condition.
Recent studies have suggested that changes of intestinal microflora of a newborn may play an important role in pathogenesis of infantile colic. Therefore, dietary supplementation with probiotics has been proposed for the improvement of this condition.
- Conditions
- Colic
- Being tested
- Biogaia L. reuteri DSM 17938, Probiotic Placebo
- Keywords
- pediatric, infantile colic, probiotic treatment
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biogaia L. reuteri DSM 17938Biological
Freeze-dried Lactobacillus reuteri DSM 17938 suspended in oil. Brand Name Active Agent: BioGaia™
Probiotic PlaceboBiological
Description of Placebo: contains same excipients as Active Agent, without the active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Biogaia L. reuteri DSM 17938 | Experimental | Biogaia L. reuteri DSM 17938, probiotic infant drops (5 drops=10^8 cfu),5 drops, once per day for 21 days. Receives: Biological: Biogaia L. reuteri DSM 17938 |
| Probiotic Placebo | Placebo comparator | Placebo drops (sunflower oil, medium chain triglyceride oil, silicon chloride), 5 drops, once a day for 21 days. Receives: Biological: Probiotic Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in crying time
Reduction of daily median crying time (measured with parental diary) with L. reuteri DSM 17938 versus placebo at any of the time points 7, 14, and 21 days
Measured: Baseline, 7 days, 14 days, 21 days
Secondary outcomes (5)
Number of responders vs. non-responders
Number of responders versus non-responders with L. reuteri versus placebo at the time points 7, 14, and 21 days. Responder is defined as a decrease in daily average crying time of 50% during the study as measured using the maternal daily diary.
Measured: Baseline, at 7, 14 and 21 days
Parental quality of life
Parental quality of life assessed by self-administered numerical rating scale from 0 (worst possible) to 10 (perfect well-being)
Measured: Daily for 21 days
Number of episodes of crying
Reduction in the number of episodes of crying (measured with parental diary) with L. reuteri DSM 17938 versus placebo
Measured: Over 21 days
Duration of episodes of crying
Reduction in the duration of episodes of crying (measured with parental diary) with L. reuteri DSM 17938 versus placebo
Measured: Over 21 days
Changes in stool consistency
Measured: Over 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startNov 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColicStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gideon Koren, The Hospital for Sick Children
- Investigators
- Gideon Koren, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541046
- Sponsor's protocol ID
- 1000018504
- Status last verified
- Nov 2014
- First submitted
- 23 Feb 2012
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chau K, Lau E, Greenberg S, Jacobson S, Yazdani-Brojeni P, Verma N, Koren G. Probiotics for infantile colic: a randomized, double-blind, placebo-controlled trial investigating Lactobacillus reuteri DSM 17938. J Pediatr. 2015 Jan;166(1):74-8. doi: 10.1016/j.jpeds.2014.09.020. Epub 2014 Oct 23.
PubMed 25444531
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactobacillus Reuteri DSM 17938 Versus Placebo in the Treatment of Infantile Colic: A Randomized Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT01541046
- Acronym / sponsor ID
- 1000018504
- Conditions
- Colic
- Keywords
- pediatric, infantile colic, probiotic treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 29 Feb 2012 (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.
Infantile colic is a common medical condition which remains a frustrating problem for parents and health care providers with no clear treatment guidelines. To fill the void in existing literature, we present a protocol to examine whether probiotics are effective in decreasing infantile colic symptoms when compared to placebo treatment.
We hypothesize that oral administration of the probiotic L. reuteri DSM 17938 will reduce symptoms of infantile colic in breastfed infants in comparison to placebo.
An interim analysis will be conducted after 50 infants randomized to monitor both safety and efficacy.
Detailed description
Infantile colic is one of the most commonly reported medical problems within the first three months of life causing appreciable distress for both parents and pediatricians. The reported incidence of infantile colic ranges from 3% to 28% in prospective studies and up to 40% in retrospective surveys.
The pathogenesis of infantile colic remains elusive despite decades of research. It appears that multiple independent origins might be involved: amongst them infant's difficult temperament, inadequate mother-infant communication or maternal anxiety, transient lactase deficiency, exposure to cow's milk, abnormal gastrointestinal function, maternal smoking during pregnancy or after delivery. Consequently, various treatment approaches have been tried to alleviate this condition.
Recent studies have suggested that changes of intestinal microflora of a newborn may play an important role in pathogenesis of infantile colic. Therefore, dietary supplementation with probiotics has been proposed for the improvement of this condition.
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 |
|---|---|---|
| Biogaia L. reuteri DSM 17938 | Experimental | Biological: Biogaia L. reuteri DSM 17938Biogaia L. reuteri DSM 17938, probiotic infant drops (5 drops=10^8 cfu),5 drops, once per day for 21 days. |
| Probiotic Placebo | Placebo comparator | Biological: Probiotic PlaceboPlacebo drops (sunflower oil, medium chain triglyceride oil, silicon chloride), 5 drops, once a day for 21 days. |
Who may qualify
- Ages
- 21 to 180 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy term infant 21-90 days of age
- Birth weight ≥2500 g
- Exclusively breastfed (to reduce variability in the intestinal microflora attributable to dietary variations)
- With colic symptoms (>3 hours of crying on >3 days per week) with debut 10 ± 5 days before enrollment
- Gestational age between 37 and 42 weeks
Key exclusion criteria (6 listed)
- Any chronic illness or gastrointestinal disorder as judged by the pediatrician
- Any history of antibiotic treatment or probiotic supplementation
- Failure to obtain a written consent by parent/legal guardian
- Participation in other clinical trials
- Infants with acute illness
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 |
|---|---|---|
| Biogaia L. reuteri DSM 17938Freeze-dried Lactobacillus reuteri DSM 17938 suspended in oil. Brand Name Active Agent: BioGaia™ | Biological | Biogaia L. reuteri DSM 17938 |
| Probiotic PlaceboDescription of Placebo: contains same excipients as Active Agent, without the active ingredient | Biological | Probiotic Placebo |
Primary outcome
Mean change in crying time
Time frame: Baseline, 7 days, 14 days, 21 days
Reduction of daily median crying time (measured with parental diary) with L. reuteri DSM 17938 versus placebo at any of the time points 7, 14, and 21 days
5 secondary outcomes
Number of responders vs. non-responders
Time frame: Baseline, at 7, 14 and 21 days
Parental quality of life
Time frame: Daily for 21 days
Number of episodes of crying
Time frame: Over 21 days
Duration of episodes of crying
Time frame: Over 21 days
Changes in stool consistency
Time frame: Over 21 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 20 Nov 2014.
- Derived from this study: PubMed 25444531Chau K, Lau E, Greenberg S, Jacobson S, Yazdani-Brojeni P, Verma N, Koren G. Probiotics for infantile colic: a randomized, double-blind, placebo-controlled trial investigating Lactobacillus reuteri DSM 17938. J Pediatr. 2015 Jan;166(1):74-8. doi: 10.1016/j.jpeds.2014.09.020. Epub 2014 Oct 23.
- Probiotics for Infantile Colic: A Randomized, Double-Blind, Placebo-Controlled Trial Investigating Lactobacillus reuteri DSM 17938Link provided by the sponsor.
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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.
Gideon Koren, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biogaia L. reuteri DSM 17938 in people with Colic, run by The Hospital for Sick Children at 1 site in Canada.
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 7 inclusion and 6 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 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean change in crying time (time frame: Baseline, 7 days, 14 days, 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01541046, which also lists 1 linked publication.
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 20 Nov 2014.