Infantile ColicColic2017NCT03360253
Clinical Trial of L. Reuteri in Infantile Colic 2017
A study testing L. reuteri DSM 17938 in drops in people with Infantile Colic, run by Innovacion y Desarrollo de Estrategias en Salud at 1 site in Mexico.
Trial summary
RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 17938 to significantly reduce the duration of crying time and fussines in infants from 15days to 4 months of age with colic, feed with human milk (30% sample) or infant formula (70%) Read more about this study
- Who is it for?
- Ages 1 week to 9 weeks
- Conditions the study is for
- Infantile Colic
- What is being tested?
- L. reuteri DSM 17938 in drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 244 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2018to 30 Jan 2020
- 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 1 week to 9 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Younger than 10 weeks of age
- Full term infant (37-42 weeks gestational age)
- Birth weight ≥ 2,500g
- Apgar score ≥ 7 at 5 minutes
- Infantile colic diagnosed according to modified Wessel's criteria (crying more than 180 min/day during 3 days for at least a week prior to enrolment)
- Parental motivation to postpone changes in the infant feeding mode, unless necessary
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- Stated availability throughout the study period
- Parent(s) willingness and ability to fill out charts and questionnaires
- Signed informed consent
Who cannot join
- Failure to thrive
- Chronic illness or major medical problem
- Gastrointestinal disease
- Use of any antibiotic 2 weeks before Day 1 in the study. This applies also to lactating mothers whose infants participate in the trial
- Use of supplements/eaten foods that contain Lactobacillus reuteri, 2 weeks before Day 1
- Use of proton pump inhibitors in the week (7 days) prior to enrolment
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- If breastfeeding, use of probiotic by the mother in the week (7 days) prior to enrolment and throughout the study period
- Use of infant formula with hydrolysed protein
- Infant receiving solid foods (such as cereals, mashed fruits or vegetable purée)
- Change of feeding mode planned by parents during the study period
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital General Dr. Manuel Gea Gonzalez
Mexico City, Tlalpan, 14080
Patricia Vidal, MSc, 525540003000 ext. 3717, vidalv.patricia@gmail.com
Monica Rodriguez, MSc, 525540003000 ext. 3717, mon.medley@gmail.com
About this study
Official title: Safety and Efficacy of Lactobacillus Reuteri DSM 17938 to Reduce the Crying Time in Infants With Colic: Randomised Controlled Trial With Two Parallel Arms. Version 3.3. Nov,11th,2016
RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 17938 to significantly reduce the duration of crying time and fussines in infants from 15days to 4 months of age with colic, feed with human milk (30% sample) or infant formula (70%)
Read the detailed description
RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 17938 administrated for 21 days to significantly reduce the duration of crying time and fussines in infants from 15days to 4 months of age with colic. 66 infants feed with human milk and 180 infant feed with infant formula will be included. As primary outcome we will measure the difference between children receiving L. reuteri DSM 17938, 108 CFU vs children receiving placebo regarding average daily crying duration (minutes per day, from average of crying from days 19 to 21 after randomization), measured by Barr diary. Secondary/exploratory outcomes will be average of crying time on day 7 and 14 (Barr diary) of L. reuteri groups vs placebo group; average of crying and fussing time on day 7, 14 and average from days 19 to 21 after randomization (Barr diary) of L. reuteri groups vs placebo group; responders percentage on day 7, 14 and 21, decrease in daily average crying time of 50% during the study; QoL (PedsQL-2.0-Family Impact Module AU2.0 spa-MX) changes from baseline to days 7, 14 and 21 and Edinburg postnatal depression scale for mothers from baseline to days 7, 14 and 21
- Conditions
- Infantile Colic
- Being tested
- L. reuteri DSM 17938 in drops, Placebo
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L. reuteri DSM 17938 in dropsDietary supplement
- reuteri DSM 17938 will be given at a dose of 5 drops containing 1x108 colony-forming units (CFU) once time per day in an oil formulation delivered from a drop bottle
PlaceboOther
The placebo consists of an identical formulation except that the L. reuteri is not present
| Study group | Role | What they receive |
|---|---|---|
| HMilkProb | Experimental | L. reuteri DSM 17938 in drops will be given at a dose of 5 drops containing 1x108 colony-forming units (CFU) once time per day in an oil formulation delivered from a drop bottle. In the active study product, freeze-dried L. reuteri is suspended in a mixture of pharmaceutical grade medium chain triglycerides and sunflower oil together to give the product the correct rheological properties Receives: Dietary Supplement: L. reuteri DSM 17938 in drops |
| HMilkPlacebo | Placebo comparator | The placebo consists of an identical formulation except that the L. reuteri is not present Receives: Other: Placebo |
| IFormProb | Experimental | L. reuteri DSM 17938 in drops will be given at a dose of 5 drops containing 1x108 colony-forming units (CFU) once time per day in an oil formulation delivered from a drop bottle. In the active study product, freeze-dried L. reuteri is suspended in a mixture of pharmaceutical grade medium chain triglycerides and sunflower oil together to give the product the correct rheological properties Receives: Dietary Supplement: L. reuteri DSM 17938 in drops |
| IFormPlacebo | Placebo comparator | The placebo consists of an identical formulation except that the L. reuteri is not present Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crying time
Difference between children receiving L. reuteri DSM 17938, 108 CFU vs children receiving placebo regarding average daily crying duration (minutes per day, from average of crying from days 19 to 21 after randomization), measured by Barr diary.
Difference between children receiving L. reuteri DSM 17938, 108 CFU vs children receiving placebo regarding average daily crying duration (minutes per day, from average of crying from days 19 to 21 after randomization), measured by Barr diary.
Measured: 21 days
Secondary outcomes (5)
Preliminary crying time
Average of crying time on day 7 and 14 (Barr diary) of L. reuteri groups vs placebo group
Measured: Day 7 and 14
Crying and fussing
Average of crying and fussing time on day 7, 14 and average from days 19 to 21 after randomization (Barr diary) of L. reuteri groups vs placebo group
Measured: 7,14 and 21 days
Total responders
Responders percentage on day 7, 14 and 21, decrease in daily average crying time of 50% during the study
Measured: 7,14 and 21 days
Impact on Quality of Life
Impact on Quality of Life measured by PedsQL-2.0-Family Impact Module AU2.0 spa-MX. Changes from baseline to days 7, 14 and 21
Measured: 7, 14 and 21 days
Maternal depression
Maternal depression evaluated with Edinburgh Postnatal Depression Scale (EPDS)
Measured: 7, 14 and 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start1 Jan 2018
- Primary completion30 Nov 2019 (estimated)
- Study completion30 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile 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
- Model description
- Randomized controlled trial, double blind allocation concealment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovacion y Desarrollo de Estrategias en Salud
- Sponsor type
- University, hospital or other
- Collaborators
- BioGaia AB
- Responsible party
- Principal investigator, Pedro Gutierrez Castrellon, Innovacion y Desarrollo de Estrategias en Salud
- Investigators
- Pedro Gutierrez-Castrellon, DSc, Principal investigator, Hospital General Dr. Manuel Gea Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360253
- Sponsor's protocol ID
- Colic2017
- Acronym
- Colic2017
- Status last verified
- Jul 2019
- First submitted
- 30 Apr 2017
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Lactobacillus Reuteri DSM 17938 to Reduce the Crying Time in Infants With Colic: Randomised Controlled Trial With Two Parallel Arms. Version 3.3. Nov,11th,2016
- ClinicalTrials.gov ID
- NCT03360253
- Acronym / sponsor ID
- Colic2017 / Colic2017
- Conditions
- Infantile Colic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Innovacion y Desarrollo de Estrategias en SaludUniversity, hospital or other
- Collaborators
- BioGaia AB
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 30 Jan 2020 (estimated)
- First posted
- 4 Dec 2017 (actual)
- 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.
RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 17938 to significantly reduce the duration of crying time and fussines in infants from 15days to 4 months of age with colic, feed with human milk (30% sample) or infant formula (70%)
Detailed description
RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 17938 administrated for 21 days to significantly reduce the duration of crying time and fussines in infants from 15days to 4 months of age with colic. 66 infants feed with human milk and 180 infant feed with infant formula will be included. As primary outcome we will measure the difference between children receiving L. reuteri DSM 17938, 108 CFU vs children receiving placebo regarding average daily crying duration (minutes per day, from average of crying from days 19 to 21 after randomization), measured by Barr diary. Secondary/exploratory outcomes will be average of crying time on day 7 and 14 (Barr diary) of L. reuteri groups vs placebo group; average of crying and fussing time on day 7, 14 and average from days 19 to 21 after randomization (Barr diary) of L. reuteri groups vs placebo group; responders percentage on day 7, 14 and 21, decrease in daily average crying time of 50% during the study; QoL (PedsQL-2.0-Family Impact Module AU2.0 spa-MX) changes from baseline to days 7, 14 and 21 and Edinburg postnatal depression scale for mothers from baseline to days 7, 14 and 21
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized controlled trial, double blind allocation concealment
| Arm | Type | Receives |
|---|---|---|
| HMilkProb | Experimental | Dietary Supplement: L. reuteri DSM 17938 in dropsL. reuteri DSM 17938 in drops will be given at a dose of 5 drops containing 1x108 colony-forming units (CFU) once time per day in an oil formulation delivered from a drop bottle. In the active study product, freeze-dried L. reuteri is suspended in a mixture of pharmaceutical grade medium chain triglycerides and sunflower oil together to give the product the correct rheological properties |
| HMilkPlacebo | Placebo comparator | Other: PlaceboThe placebo consists of an identical formulation except that the L. reuteri is not present |
| IFormProb | Experimental | Dietary Supplement: L. reuteri DSM 17938 in dropsL. reuteri DSM 17938 in drops will be given at a dose of 5 drops containing 1x108 colony-forming units (CFU) once time per day in an oil formulation delivered from a drop bottle. In the active study product, freeze-dried L. reuteri is suspended in a mixture of pharmaceutical grade medium chain triglycerides and sunflower oil together to give the product the correct rheological properties |
| IFormPlacebo | Placebo comparator | Other: PlaceboThe placebo consists of an identical formulation except that the L. reuteri is not present |
Who may qualify
- Ages
- 1 week to 9 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Younger than 10 weeks of age
- Full term infant (37-42 weeks gestational age)
- Birth weight ≥ 2,500g
- Apgar score ≥ 7 at 5 minutes
- Infantile colic diagnosed according to modified Wessel's criteria (crying more than 180 min/day during 3 days for at least a week prior to enrolment)
Key exclusion criteria (10 listed)
- Failure to thrive
- Chronic illness or major medical problem
- Gastrointestinal disease
- Use of any antibiotic 2 weeks before Day 1 in the study. This applies also to lactating mothers whose infants participate in the trial
- Use of supplements/eaten foods that contain Lactobacillus reuteri, 2 weeks before Day 1
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 |
|---|---|---|
| L. reuteri DSM 17938 in dropsL. reuteri DSM 17938 will be given at a dose of 5 drops containing 1x108 colony-forming units (CFU) once time per day in an oil formulation delivered from a drop bottle | Dietary supplement | HMilkProb, IFormProb |
| PlaceboThe placebo consists of an identical formulation except that the L. reuteri is not present | Other | HMilkPlacebo, IFormPlacebo |
Primary outcome
Crying time
Time frame: 21 days
Difference between children receiving L. reuteri DSM 17938, 108 CFU vs children receiving placebo regarding average daily crying duration (minutes per day, from average of crying from days 19 to 21 after randomization), measured by Barr diary. Difference between children receiving L. reuteri DSM 17938, 108 CFU vs children receiving placebo regarding average daily crying duration (minutes per day, from average of crying from days 19 to 21 after randomization), measured by Barr diary.
5 secondary outcomes
Preliminary crying time
Time frame: Day 7 and 14
Crying and fussing
Time frame: 7,14 and 21 days
Total responders
Time frame: 7,14 and 21 days
Impact on Quality of Life
Time frame: 7, 14 and 21 days
Maternal depression
Time frame: 7, 14 and 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Pedro Gutierrez-Castrellon, DSc principal investigator
Hospital General Dr. Manuel Gea Gonzalez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L. reuteri DSM 17938 in drops in people with Infantile Colic, run by Innovacion y Desarrollo de Estrategias en Salud at 1 site in Mexico.
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 9 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 30 Jul 2019. 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 Mexico. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Vidal, MSc (525540003000 ext. 3717, vidalv.patricia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crying time (time frame: 21 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 30 Jul 2019.