ColicPhase 2/3NCT02577133
Prevention of Colic With the Probiotic Lactobacillus Reuteri
A Phase 2/3 study testing Lactobacillus reuteri DSM 17938 in people with Colic, run by Hospital General Naval de Alta Especialidad - Escuela Medico Naval.
Trial summary
Colic is a term for inconsolable crying happened in the first months of life. Its etiology is multifactorial and caregiver and pediatrician generates among other problems: anxiety, risk of child abuse as well as economic costs. Read more about this study
- Who is it for?
- Ages 1 day to 1 week
- Conditions the study is for
- Colic
- What is being tested?
- Lactobacillus reuteri DSM 17938
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 478 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Oct 2016
- Phase
- Phase 2/3
- 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 day to 1 week
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Term Healthy Newborns (RN) ≥38 weeks and ≤ 41 weeks of gestation.
- Appropriate weight for gestational age
- ≥than 8 Apgar at 5 minutes
- Egress at the first 24-48 hours of life of the newborn with the mother of hospital
- No congenital or physical abnormalities on physical examination at birth.
- Availability during the study period.
- Thorough understanding of the protocol by parents
- Informed Consent is signed by both parents.
Who cannot join
- Administration of antibiotics to the mother for a week before the birth of the newborn.
- Administration of probiotics newborn before inclusion or consumption by the mother during these last two trimesters.
- Medication Management newborn different routine prescribed at birth.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prevention of Colic With the Probiotic Lactobacillus Reuteri in Mexican Infants: Randomized, Double-blind Study
Colic is a term for inconsolable crying happened in the first months of life. Its etiology is multifactorial and caregiver and pediatrician generates among other problems: anxiety, risk of child abuse as well as economic costs.
There is now enough evidence for the treatment of colic using probiotics, especially Lactobacillus reuteri.
Read more
The investigators study aims to demonstrate the utility for the prevention of colic with L. reuteri and thereby avoid the problems caused by this pathology.
Objective: Compare the number of events of colic among infants with oral probiotic Lactobacillus reuteri during the first month of life versus infants with placebo
Study Design. Double blind, randomized, controlled, 492 neonates of 37-42 gestational age, breast or formula fed, will receive L. reuteri 5 drops (1x108 CFU) daily or placebo for 28 days. The investigators trial will be performed at Naval Hospital in Mexico City.
Read the detailed description
Methods:
This study is planned for October 2015 to October 2016 aiming newborns born population in Naval Hospital
Inclusion:
- Term Healthy Newborns (RN) ≥38 weeks and ≤ 41 weeks of gestation
- Appropriate weight for gestational age
- ≥than 8 Apgar at 5 minutes
- Egress at the first 24-48 hours of life of the newborn with the mother of hospital
- No congenital or physical abnormalities on physical examination at birth.
- Availability during the study period.
- Thorough understanding of the protocol by parents
- Informed Consent is signed by both parents.
Exclusion:
- Administration of antibiotics to the mother for a week before the birth of the newborn.
- Administration of probiotics newborn before inclusion or consumption by the mother during these last two trimesters.
- Medication Management newborn different routine prescribed at birth.
Elimination
- Loss of monitoring
- Abandonment by parents
- Diagnosis of allergy to cow's milk protein (confirmed by resolution of symptoms after switching to Formula hypo allergenic or free feeding cow's milk by the mother in breastfed children).
- Diagnosis of structural alterations or gastrointestinal illness to explain the symptoms of colic in the following months after the inclusion
Interventions:
The patients enrolled will receive probiotics (1000000000 CFU per day) or placebo every days for 28 days
Weekly, each patient will be called twice to interrogate the number of events colic as well as the different variables under study
After birth, on 15, 30, 45 and 60 of life will be cited for clinical examination and review and weight dropper bottle of probiotic
- Principal: Number of events or inconsolable crying
- Secondary: Average or evacuations / day Average or regurgitation / day Drugs to decrease excessive crying Medical reviews for excessive crying Changes feeding for excessive crying Level of satisfaction with the care of the newborn (numerical scale from 0: the worst possible, 10: completely satisfied)
- Universal variables
Weight:
Size:
Gender Weeks gestation Type of birth Feeding of formula / breast-
- Conditions
- Colic
- Being tested
- Lactobacillus reuteri DSM 17938, Placebo
- Keywords
- colic, probiotic, Lactobacillus reuteri, prevention
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteri DSM 17938Dietary supplement
Also called BioGaia
Lactobacillus reuteri DSM 17938 1,000,000,000 CFU per day (5 drops) for 28 days
PlaceboDietary supplement
The placebo consisted of an identical bottle with distilled water
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus reuteri group | Active comparator | Lactobacillus reuteri DSM 17938 1,000,000,000 CFU per day (5 drops) for 28 days Receives: Dietary Supplement: Lactobacillus reuteri DSM 17938 |
| Placebo group | Placebo comparator | Placebo (5 drops) for 28 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event number of colic
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 478 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Naval de Alta Especialidad - Escuela Medico Naval
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Jorge Ivan Valencia Moncada, Hospital General Naval de Alta Especialidad - Escuela Medico Naval
- Investigators
- Héctor Javier Varona Bobadilla, Dr., Principal investigator, Secretaria de Marina-Armada de México (Mexican Navy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577133
- Sponsor's protocol ID
- HGNAE-04
- Status last verified
- Oct 2015
- First submitted
- 14 Oct 2015
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hyman PE, Milla PJ, Benninga MA, Davidson GP, Fleisher DF, Taminiau J. Childhood functional gastrointestinal disorders: neonate/toddler. Gastroenterology. 2006 Apr;130(5):1519-26. doi: 10.1053/j.gastro.2005.11.065.
PubMed 16678565WESSEL MA, COBB JC, JACKSON EB, HARRIS GS Jr, DETWILER AC. Paroxysmal fussing in infancy, sometimes called colic. Pediatrics. 1954 Nov;14(5):421-35. No abstract available.
PubMed 13214956Douglas P, Hill P. Managing infants who cry excessively in the first few months of life. BMJ. 2011 Dec 15;343:d7772. doi: 10.1136/bmj.d7772. No abstract available.
PubMed 22174332E. Ortega Páeza , D. Barroso Espaderob Flashes pediátricos AEpap Cólico del lactante Rev Pediatr Aten Primaria Supl. 2013;(22):81-7
Wolke D, Samara M, Alvarez Wolke M. Meta-analysis of fuss/cry durations and colic prevalence across countries: Proceedings of the11th International Infant Cry Research Workshop, June, 2011, The Netherlands.
Cohen GM, Albertini LW. Colic. Pediatr Rev. 2012 Jul;33(7):332-3; discussion 333. doi: 10.1542/pir.33-7-332. No abstract available.
PubMed 22753793Barr RG, Rotman A, Yaremko J, Leduc D, Francoeur TE. The crying of infants with colic: a controlled empirical description. Pediatrics. 1992 Jul;90(1 Pt 1):14-21.
PubMed 1614771Romanello S, Spiri D, Marcuzzi E, Zanin A, Boizeau P, Riviere S, Vizeneux A, Moretti R, Carbajal R, Mercier JC, Wood C, Zuccotti GV, Crichiutti G, Alberti C, Titomanlio L. Association between childhood migraine and history of infantile colic. JAMA. 2013 Apr 17;309(15):1607-12. doi: 10.1001/jama.2013.747.
PubMed 23592105Savino F, Cordisco L, Tarasco V, Calabrese R, Palumeri E, Matteuzzi D. Molecular identification of coliform bacteria from colicky breastfed infants. Acta Paediatr. 2009 Oct;98(10):1582-8. doi: 10.1111/j.1651-2227.2009.01419.x. Epub 2009 Jul 9.
PubMed 19604166de Weerth C, Fuentes S, Puylaert P, de Vos WM. Intestinal microbiota of infants with colic: development and specific signatures. Pediatrics. 2013 Feb;131(2):e550-8. doi: 10.1542/peds.2012-1449. Epub 2013 Jan 14.
PubMed 23319531Savino F, Cresi F, Pautasso S, Palumeri E, Tullio V, Roana J, Silvestro L, Oggero R. Intestinal microflora in breastfed colicky and non-colicky infants. Acta Paediatr. 2004 Jun;93(6):825-9.
PubMed 15244234Iacono G, Merolla R, D'Amico D, Bonci E, Cavataio F, Di Prima L, Scalici C, Indinnimeo L, Averna MR, Carroccio A; Paediatric Study Group on Gastrointestinal Symptoms in Infancy. Gastrointestinal symptoms in infancy: a population-based prospective study. Dig Liver Dis. 2005 Jun;37(6):432-8. doi: 10.1016/j.dld.2005.01.009. Epub 2005 Mar 2.
PubMed 15893282Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006 Apr;130(5):1377-90. doi: 10.1053/j.gastro.2006.03.008. No abstract available.
PubMed 16678553Charrois TL, Sandhu G, Vohra S. Probiotics. Pediatr Rev. 2006 Apr;27(4):137-9. doi: 10.1542/pir.27-4-137. No abstract available.
PubMed 16581954http://www.biogaia.com/lactobacillus-reuter
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Colic With the Probiotic Lactobacillus Reuteri in Mexican Infants: Randomized, Double-blind Study
- ClinicalTrials.gov ID
- NCT02577133
- Acronym / sponsor ID
- HGNAE-04
- Conditions
- Colic
- Keywords
- colic, probiotic, Lactobacillus reuteri, prevention
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 478 participants (estimated)
- Lead sponsor
- Hospital General Naval de Alta Especialidad - Escuela Medico NavalOther government
- Study start
- Oct 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 16 Oct 2015 (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.
Colic is a term for inconsolable crying happened in the first months of life. Its etiology is multifactorial and caregiver and pediatrician generates among other problems: anxiety, risk of child abuse as well as economic costs.
There is now enough evidence for the treatment of colic using probiotics, especially Lactobacillus reuteri.
The investigators study aims to demonstrate the utility for the prevention of colic with L. reuteri and thereby avoid the problems caused by this pathology.
Objective: Compare the number of events of colic among infants with oral probiotic Lactobacillus reuteri during the first month of life versus infants with placebo
Study Design. Double blind, randomized, controlled, 492 neonates of 37-42 gestational age, breast or formula fed, will receive L. reuteri 5 drops (1x108 CFU) daily or placebo for 28 days. The investigators trial will be performed at Naval Hospital in Mexico City.
Detailed description
Methods:
This study is planned for October 2015 to October 2016 aiming newborns born population in Naval Hospital
Inclusion:
- Term Healthy Newborns (RN) ≥38 weeks and ≤ 41 weeks of gestation
- Appropriate weight for gestational age
- ≥than 8 Apgar at 5 minutes
- Egress at the first 24-48 hours of life of the newborn with the mother of hospital
- No congenital or physical abnormalities on physical examination at birth.
- Availability during the study period.
- Thorough understanding of the protocol by parents
- Informed Consent is signed by both parents.
Exclusion:
- Administration of antibiotics to the mother for a week before the birth of the newborn.
- Administration of probiotics newborn before inclusion or consumption by the mother during these last two trimesters.
- Medication Management newborn different routine prescribed at birth.
Elimination
- Loss of monitoring
- Abandonment by parents
- Diagnosis of allergy to cow's milk protein (confirmed by resolution of symptoms after switching to Formula hypo allergenic or free feeding cow's milk by the mother in breastfed children).
- Diagnosis of structural alterations or gastrointestinal illness to explain the symptoms of colic in the following months after the inclusion
Interventions:
The patients enrolled will receive probiotics (1000000000 CFU per day) or placebo every days for 28 days
Weekly, each patient will be called twice to interrogate the number of events colic as well as the different variables under study
After birth, on 15, 30, 45 and 60 of life will be cited for clinical examination and review and weight dropper bottle of probiotic
- Principal: Number of events or inconsolable crying
- Secondary: Average or evacuations / day Average or regurgitation / day Drugs to decrease excessive crying Medical reviews for excessive crying Changes feeding for excessive crying Level of satisfaction with the care of the newborn (numerical scale from 0: the worst possible, 10: completely satisfied)
- Universal variables
Weight:
Size:
Gender Weeks gestation Type of birth Feeding of formula / breast-
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus reuteri group | Active comparator | Dietary Supplement: Lactobacillus reuteri DSM 17938Lactobacillus reuteri DSM 17938 1,000,000,000 CFU per day (5 drops) for 28 days |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboPlacebo (5 drops) for 28 days |
Who may qualify
- Ages
- 1 day to 1 week
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Term Healthy Newborns (RN) ≥38 weeks and ≤ 41 weeks of gestation.
- Appropriate weight for gestational age
- ≥than 8 Apgar at 5 minutes
- Egress at the first 24-48 hours of life of the newborn with the mother of hospital
- No congenital or physical abnormalities on physical examination at birth.
Key exclusion criteria (3 listed)
- Administration of antibiotics to the mother for a week before the birth of the newborn.
- Administration of probiotics newborn before inclusion or consumption by the mother during these last two trimesters.
- Medication Management newborn different routine prescribed at birth.
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 |
|---|---|---|
| Lactobacillus reuteri DSM 17938Also: BioGaiaLactobacillus reuteri DSM 17938 1,000,000,000 CFU per day (5 drops) for 28 days | Dietary supplement | Lactobacillus reuteri group |
| PlaceboThe placebo consisted of an identical bottle with distilled water | Dietary supplement | Placebo group |
Primary outcome
Event number of colic
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
- Background: PubMed 16678565Hyman PE, Milla PJ, Benninga MA, Davidson GP, Fleisher DF, Taminiau J. Childhood functional gastrointestinal disorders: neonate/toddler. Gastroenterology. 2006 Apr;130(5):1519-26. doi: 10.1053/j.gastro.2005.11.065.
- Background: PubMed 13214956WESSEL MA, COBB JC, JACKSON EB, HARRIS GS Jr, DETWILER AC. Paroxysmal fussing in infancy, sometimes called colic. Pediatrics. 1954 Nov;14(5):421-35. No abstract available.
- Background: PubMed 22174332Douglas P, Hill P. Managing infants who cry excessively in the first few months of life. BMJ. 2011 Dec 15;343:d7772. doi: 10.1136/bmj.d7772. No abstract available.
- BackgroundE. Ortega Páeza , D. Barroso Espaderob Flashes pediátricos AEpap Cólico del lactante Rev Pediatr Aten Primaria Supl. 2013;(22):81-7
- BackgroundWolke D, Samara M, Alvarez Wolke M. Meta-analysis of fuss/cry durations and colic prevalence across countries: Proceedings of the11th International Infant Cry Research Workshop, June, 2011, The Netherlands.
- Background: PubMed 22753793Cohen GM, Albertini LW. Colic. Pediatr Rev. 2012 Jul;33(7):332-3; discussion 333. doi: 10.1542/pir.33-7-332. No abstract available.
- Background: PubMed 1614771Barr RG, Rotman A, Yaremko J, Leduc D, Francoeur TE. The crying of infants with colic: a controlled empirical description. Pediatrics. 1992 Jul;90(1 Pt 1):14-21.
- Background: PubMed 23592105Romanello S, Spiri D, Marcuzzi E, Zanin A, Boizeau P, Riviere S, Vizeneux A, Moretti R, Carbajal R, Mercier JC, Wood C, Zuccotti GV, Crichiutti G, Alberti C, Titomanlio L. Association between childhood migraine and history of infantile colic. JAMA. 2013 Apr 17;309(15):1607-12. doi: 10.1001/jama.2013.747.
- Background: PubMed 19604166Savino F, Cordisco L, Tarasco V, Calabrese R, Palumeri E, Matteuzzi D. Molecular identification of coliform bacteria from colicky breastfed infants. Acta Paediatr. 2009 Oct;98(10):1582-8. doi: 10.1111/j.1651-2227.2009.01419.x. Epub 2009 Jul 9.
- Background: PubMed 23319531de Weerth C, Fuentes S, Puylaert P, de Vos WM. Intestinal microbiota of infants with colic: development and specific signatures. Pediatrics. 2013 Feb;131(2):e550-8. doi: 10.1542/peds.2012-1449. Epub 2013 Jan 14.
- Background: PubMed 15244234Savino F, Cresi F, Pautasso S, Palumeri E, Tullio V, Roana J, Silvestro L, Oggero R. Intestinal microflora in breastfed colicky and non-colicky infants. Acta Paediatr. 2004 Jun;93(6):825-9.
- Background: PubMed 15893282Iacono G, Merolla R, D'Amico D, Bonci E, Cavataio F, Di Prima L, Scalici C, Indinnimeo L, Averna MR, Carroccio A; Paediatric Study Group on Gastrointestinal Symptoms in Infancy. Gastrointestinal symptoms in infancy: a population-based prospective study. Dig Liver Dis. 2005 Jun;37(6):432-8. doi: 10.1016/j.dld.2005.01.009. Epub 2005 Mar 2.
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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.
Héctor Javier Varona Bobadilla, Dr. principal investigator
Secretaria de Marina-Armada de México (Mexican Navy)
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lactobacillus reuteri DSM 17938 in people with Colic, run by Hospital General Naval de Alta Especialidad - Escuela Medico Naval.
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 3 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 16 Oct 2015. 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Héctor Javier Varona Bobadilla, Dr. ((52) 55 56 24 65 00 ext. 5423, kavel_555@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event number of colic (time frame: 3 months). 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 NCT02577133, which also lists 23 linked publications.
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 16 Oct 2015.