Crying Time in Colicky InfantsNCT02574065
Effects on Crying Time in Colicky Infants With the Supplementation of Lactobacillus Reuteri DSM 17938
A study testing L. reuteri DSM 17938 in people with Crying Time in Colicky Infants, run by Shanghai Children's Hospital at 1 site in China.
Trial summary
Infant colic is a common condition characterized by excessive crying. The otherwise healthy infant aged less than 3 months is difficult to console during the periods with crying. The condition is defined by modified Wessel's criteria i.e. Read more about this study
- Who is it for?
- Ages Up to 4 months
- Conditions the study is for
- Crying Time in Colicky Infants
- What is being tested?
- L. reuteri DSM 17938
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Apr 2017
- 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 Up to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis according to modified Wessel's definition of infant colic i.e. crying for more than 3 hours of the day, for more than3 days of the week
- Full term infant, i.e. gestational age between 37 and 42 weeks
- Breast fed, either exclusively or predominantly, i.e. to more than 50%
- Birth weight 2500 - 4000g.
- Apgar score ≥7 at 5 minutes at birth
- Age from birth to 4 months of age
Show all 10Show fewer
- Parent(s) willingness to postpone major changes in the infant feeding mode
- Parent(s) willingness and ability to fill in diary and questionnaires
- Written informed consent from parents
- Stated availability throughout the study period
Who cannot join
- Chronic illness or major medical problem
- Gastrointestinal disease
- Failure to thrive
- Use of antibiotics two weeks before randomisation and throughout the intervention period, both infant and mother
- Use of probiotics two weeks before randomisation and throughout the intervention period, both infant (infant formula and/or supplementation)and mother
- Use of proton pump inhibitors two weeks before randomisation and throughout the intervention period.
- Infant receiving solid foods, such as cereals, mashed fruits or vegetable puree
- Participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Shanghai
Shanghai, Shanghai Municipality, 200062
Ting Zhang, MD, +86 18016487615, zhangt@shchildren.com.cn
Xiaoyu Pan, +86-21-52976338, panxy@shchildren.com.cn
About this study
Official title: Effects on Crying Time in Colicky Infants With the Supplementation of Lactobacillus Reuteri DSM 17938: A Randomized, Double Blind, Placebo-controlled Study
Infant colic is a common condition characterized by excessive crying. The otherwise healthy infant aged less than 3 months is difficult to console during the periods with crying. The condition is defined by modified Wessel's criteria i.e. crying for more than 3 hours of the day, for more than 3 days of the week for at least 1 week.
The description of infant colic hasalso been defined by Rome III diagnostic criteria andincludes infants from birth to 4 months of age,without failure to thrive, that are showing paroxysms of irritability, fussing or crying that starts and stops without obvious cause. The episodes last 3 or more hours/day and occur at least 3days/week for at least one week. The infant has no signs of central nervous system or intrinsic developmental difficulties, is normal on physical examination, and has normal growth patterns.
Read more
Although infant colic is considered to be self limiting it is a distressing problem for families. It is in fact one of the most common reasons why parents seek the advice of a paediatrician or family practitioner during their child's first 3 months of life Up to 20% of infants under three months are affected by infant colic.
Infant colic could have significant adverse effects on family quality of life and could even be a trigger for shaken baby syndrome. Parental perception associated with colicky complaints is therefor strongly recommended to be an outcome measure in trials of infantile colic.
Measurement of parental/family quality of life and parental perception of colic severity with the help of a Visual Analogue Scale (VAS) in a Polish study showed that the use of a probiotic, Lactobacillus reuteri DSM 17938, could improve the perceived problems.
The relationship between infant colic and gastroenterological, allergical and psychological disorders later in childhood was studied in a prospective study on 96 infants divided into two groups, colicky and non-colicky. The children diagnosed with infant colic, showed an increased susceptibility to recurrent abdominal pain, allergic and psychological disorders in childhood when they were 10 years old.
The aetiology of infantile colic seems to be multifactorialbut is,despite many years of research, still unknown. The intestinal microbiota differs between infants with and without colic and has therefore been suggested to have a potential role. Other possible explanations are for example gut motility disturbances, low-grade mucosal inflammation and visceral hypersensitivity.
Evidence suggests thatadministration of the probioticL. reuteri DSM 17938 might offer some benefit.L. reuteri DSM 17938 has been tested for its effect on crying in colicky infants and has been demonstrated to have a significantly favourable effect on crying time in fivetrials. One is a randomized trial that compared the probioticto Simethicone; three areplacebo controlled randomized double blind trials and yet another is a placebo controlled randomized, single blind, observational study. A fifth studydid not find any effect.
Combining the results in a meta-analysis from three double blind, placebo controlled randomized trials (published at the time of the analysis, including the neutral one) found that, compared with placebo, L. reuteri administration reduced crying time at day 21 with about 40 min.
Recently it has been documented in a clinical trial that prophylactic use of L. reuteriDSM 17938during the first three months of lifereduced the onset offunctional gastrointestinal disorders, particularly functional constipation, regurgitation and infantile colic.
In conclusion, the administration L. reuteri DSM 17938 may reduce the crying time in children with infantile colic, especially those fed predominantly or exclusively with breast milk. However, further randomized controlled studies, are required to be able develop recommendations in the management of infant colic.
The present trial is undertaken to further document the effect of L. reuteri DSM 17938 on crying in colicky infants.
- Conditions
- Crying Time in Colicky Infants
- Being tested
- L. reuteri DSM 17938, The placebo consists of an identical formulation without L. reuteri DSM 17938
- Keywords
- crying, colicky, infants, Lactobacillus reuteri DSM 17938
- Medical subject headings
- Crying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L. reuteri DSM 17938Drug
Effects on crying time in colicky infants with the supplementation of Lactobacillus reuteri DSM 17938
The placebo consists of an identical formulation without L. reuteri DSM 17938Other
| Study group | Role | What they receive |
|---|---|---|
| L. reuteri DSM 17938 group | Experimental | L. reuteri DSM 17938 will be given at a dose of 100000000 colony forming units (CFU) 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 with pharmaceutical grade silicon dioxide to give the product the correct rheological properties.
Each day, at about the same time, the infants will be given 5 drops (1x100000000 CFU) of the study product in connection with feeding. Receives: Drug: L. reuteri DSM 17938 |
| Placebo group | Placebo comparator | The placebo consists of an identical formulation without L. reuteri. Each day, at about the same time, the infants will be given 5 drops placebo in connection with feeding. Receives: Other: The placebo consists of an identical formulation without L. reuteri DSM 17938 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily crying time will be measured at Day 7 through questionnaire finished by parents.
50 evaluable infants in each group will be needed to detect (i.e. get a two-sided p-value less than 5%) a 50 minutes difference in crying time between L. reuteri DSM 17938 and placebo group and with a 90 minutes standard deviation, and a power of 80%, two-sided hypothesis.
Measured: Day 7
Daily crying time will be measured at Day 14 through questionnaire finished by parents.
50 evaluable infants in each group will be needed to detect (i.e. get a two-sided p-value less than 5%) a 50 minutes difference in crying time between L. reuteri DSM 17938 and placebo group and with a 90 minutes standard deviation, and a power of 80%, two-sided hypothesis.
Measured: Day 14
Daily crying time will be measured at Day 21 through questionnaire finished by parents.
50 evaluable infants in each group will be needed to detect (i.e. get a two-sided p-value less than 5%) a 50 minutes difference in crying time between L. reuteri DSM 17938 and placebo group and with a 90 minutes standard deviation, and a power of 80%, two-sided hypothesis.
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startMar 2016
- Primary completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Crying Time in Colicky InfantsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BioGaia AB, Suzhou University Affiliated Children's Hospital, Shanghai Children's Medical Center
- Responsible party
- Principal investigator, Zhang Ting, Shanghai Children's Hospital
- Investigators
- Ting Zhang, MD, Principal investigator, Shanghai Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574065
- Sponsor's protocol ID
- CSUB0090
- Status last verified
- Oct 2016
- First submitted
- 20 Aug 2015
- Last updated
- 31 Oct 2016
- Results posted
- No
Publications
Abrahamsson TR, Jakobsson T, Bottcher MF, Fredrikson M, Jenmalm MC, Bjorksten B, Oldaeus G. Probiotics in prevention of IgE-associated eczema: a double-blind, randomized, placebo-controlled trial. J Allergy Clin Immunol. 2007 May;119(5):1174-80. doi: 10.1016/j.jaci.2007.01.007. Epub 2007 Mar 8.
PubMed 17349686Barr RG, Kramer MS, Boisjoly C, McVey-White L, Pless IB. Parental diary of infant cry and fuss behaviour. Arch Dis Child. 1988 Apr;63(4):380-7. doi: 10.1136/adc.63.4.380.
PubMed 3365007Chau 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 25444531Hyman 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 16678565Indrio F, Riezzo G, Raimondi F, Bisceglia M, Cavallo L, Francavilla R. The effects of probiotics on feeding tolerance, bowel habits, and gastrointestinal motility in preterm newborns. J Pediatr. 2008 Jun;152(6):801-6. doi: 10.1016/j.jpeds.2007.11.005. Epub 2007 Dec 26.
PubMed 18492520Indrio F, Di Mauro A, Riezzo G. Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation--reply. JAMA Pediatr. 2014 Aug;168(8):778. doi: 10.1001/jamapediatrics.2014.368. No abstract available.
PubMed 25090301Lucassen PL, Assendelft WJ, van Eijk JT, Gubbels JW, Douwes AC, van Geldrop WJ. Systematic review of the occurrence of infantile colic in the community. Arch Dis Child. 2001 May;84(5):398-403. doi: 10.1136/adc.84.5.398.
PubMed 11316682Savino 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 15244234Savino F, Bailo E, Oggero R, Tullio V, Roana J, Carlone N, Cuffini AM, Silvestro L. Bacterial counts of intestinal Lactobacillus species in infants with colic. Pediatr Allergy Immunol. 2005 Feb;16(1):72-5. doi: 10.1111/j.1399-3038.2005.00207.x.
PubMed 15693915Savino F, Pelle E, Palumeri E, Oggero R, Miniero R. Lactobacillus reuteri (American Type Culture Collection Strain 55730) versus simethicone in the treatment of infantile colic: a prospective randomized study. Pediatrics. 2007 Jan;119(1):e124-30. doi: 10.1542/peds.2006-1222.
PubMed 17200238Steutel NF, Benninga MA, Langendam MW, de Kruijff I, Tabbers MM. Reporting outcome measures in trials of infant colic. J Pediatr Gastroenterol Nutr. 2014 Sep;59(3):341-6. doi: 10.1097/MPG.0000000000000412.
PubMed 24796800Sung V, Hiscock H, Tang ML, Mensah FK, Nation ML, Satzke C, Heine RG, Stock A, Barr RG, Wake M. Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial. BMJ. 2014 Apr 1;348:g2107. doi: 10.1136/bmj.g2107.
PubMed 24690625Szajewska H, Gyrczuk E, Horvath A. Lactobacillus reuteri DSM 17938 for the management of infantile colic in breastfed infants: a randomized, double-blind, placebo-controlled trial. J Pediatr. 2013 Feb;162(2):257-62. doi: 10.1016/j.jpeds.2012.08.004. Epub 2012 Sep 14.
PubMed 22981952de 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 23319531WESSEL 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 13214956
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Crying Time in Colicky Infants With the Supplementation of Lactobacillus Reuteri DSM 17938: A Randomized, Double Blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT02574065
- Acronym / sponsor ID
- CSUB0090
- Conditions
- Crying Time in Colicky Infants
- Keywords
- crying, colicky, infants, Lactobacillus reuteri DSM 17938
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Shanghai Children's HospitalUniversity, hospital or other
- Collaborators
- BioGaia AB, Suzhou University Affiliated Children's Hospital, Shanghai Children's Medical Center
- Study start
- Mar 2016
- Primary completion
- Apr 2017 (estimated)
- First posted
- 12 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.
Infant colic is a common condition characterized by excessive crying. The otherwise healthy infant aged less than 3 months is difficult to console during the periods with crying. The condition is defined by modified Wessel's criteria i.e. crying for more than 3 hours of the day, for more than 3 days of the week for at least 1 week.
The description of infant colic hasalso been defined by Rome III diagnostic criteria andincludes infants from birth to 4 months of age,without failure to thrive, that are showing paroxysms of irritability, fussing or crying that starts and stops without obvious cause. The episodes last 3 or more hours/day and occur at least 3days/week for at least one week. The infant has no signs of central nervous system or intrinsic developmental difficulties, is normal on physical examination, and has normal growth patterns.
Although infant colic is considered to be self limiting it is a distressing problem for families. It is in fact one of the most common reasons why parents seek the advice of a paediatrician or family practitioner during their child's first 3 months of life Up to 20% of infants under three months are affected by infant colic.
Infant colic could have significant adverse effects on family quality of life and could even be a trigger for shaken baby syndrome. Parental perception associated with colicky complaints is therefor strongly recommended to be an outcome measure in trials of infantile colic.
Measurement of parental/family quality of life and parental perception of colic severity with the help of a Visual Analogue Scale (VAS) in a Polish study showed that the use of a probiotic, Lactobacillus reuteri DSM 17938, could improve the perceived problems.
The relationship between infant colic and gastroenterological, allergical and psychological disorders later in childhood was studied in a prospective study on 96 infants divided into two groups, colicky and non-colicky. The children diagnosed with infant colic, showed an increased susceptibility to recurrent abdominal pain, allergic and psychological disorders in childhood when they were 10 years old.
The aetiology of infantile colic seems to be multifactorialbut is,despite many years of research, still unknown. The intestinal microbiota differs between infants with and without colic and has therefore been suggested to have a potential role. Other possible explanations are for example gut motility disturbances, low-grade mucosal inflammation and visceral hypersensitivity.
Evidence suggests thatadministration of the probioticL. reuteri DSM 17938 might offer some benefit.L. reuteri DSM 17938 has been tested for its effect on crying in colicky infants and has been demonstrated to have a significantly favourable effect on crying time in fivetrials. One is a randomized trial that compared the probioticto Simethicone; three areplacebo controlled randomized double blind trials and yet another is a placebo controlled randomized, single blind, observational study. A fifth studydid not find any effect.
Combining the results in a meta-analysis from three double blind, placebo controlled randomized trials (published at the time of the analysis, including the neutral one) found that, compared with placebo, L. reuteri administration reduced crying time at day 21 with about 40 min.
Recently it has been documented in a clinical trial that prophylactic use of L. reuteriDSM 17938during the first three months of lifereduced the onset offunctional gastrointestinal disorders, particularly functional constipation, regurgitation and infantile colic.
In conclusion, the administration L. reuteri DSM 17938 may reduce the crying time in children with infantile colic, especially those fed predominantly or exclusively with breast milk. However, further randomized controlled studies, are required to be able develop recommendations in the management of infant colic.
The present trial is undertaken to further document the effect of L. reuteri DSM 17938 on crying in colicky infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L. reuteri DSM 17938 group | Experimental | Drug: L. reuteri DSM 17938L. reuteri DSM 17938 will be given at a dose of 100000000 colony forming units (CFU) 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 with pharmaceutical grade silicon dioxide to give the product the correct rheological properties. Each day, at about the same time, the infants will be given 5 drops (1x100000000 CFU) of the study product in connection with feeding. |
| Placebo group | Placebo comparator | Other: The placebo consists of an identical formulation without L. reuteri DSM 17938The placebo consists of an identical formulation without L. reuteri. Each day, at about the same time, the infants will be given 5 drops placebo in connection with feeding. |
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Diagnosis according to modified Wessel's definition of infant colic i.e. crying for more than 3 hours of the day, for more than3 days of the week
- Full term infant, i.e. gestational age between 37 and 42 weeks
- Breast fed, either exclusively or predominantly, i.e. to more than 50%
- Birth weight 2500 - 4000g.
- Apgar score ≥7 at 5 minutes at birth
Key exclusion criteria (8 listed)
- Chronic illness or major medical problem
- Gastrointestinal disease
- Failure to thrive
- Use of antibiotics two weeks before randomisation and throughout the intervention period, both infant and mother
- Use of probiotics two weeks before randomisation and throughout the intervention period, both infant (infant formula and/or supplementation)and 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 |
|---|---|---|
| L. reuteri DSM 17938Effects on crying time in colicky infants with the supplementation of Lactobacillus reuteri DSM 17938 | Drug | L. reuteri DSM 17938 group |
| The placebo consists of an identical formulation without L. reuteri DSM 17938 | Other | Placebo group |
Primary outcome
Daily crying time will be measured at Day 7 through questionnaire finished by parents.
Time frame: Day 7
50 evaluable infants in each group will be needed to detect (i.e. get a two-sided p-value less than 5%) a 50 minutes difference in crying time between L. reuteri DSM 17938 and placebo group and with a 90 minutes standard deviation, and a power of 80%, two-sided hypothesis.
Daily crying time will be measured at Day 14 through questionnaire finished by parents.
Time frame: Day 14
50 evaluable infants in each group will be needed to detect (i.e. get a two-sided p-value less than 5%) a 50 minutes difference in crying time between L. reuteri DSM 17938 and placebo group and with a 90 minutes standard deviation, and a power of 80%, two-sided hypothesis.
Daily crying time will be measured at Day 21 through questionnaire finished by parents.
Time frame: Day 21
50 evaluable infants in each group will be needed to detect (i.e. get a two-sided p-value less than 5%) a 50 minutes difference in crying time between L. reuteri DSM 17938 and placebo group and with a 90 minutes standard deviation, and a power of 80%, two-sided hypothesis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Background: PubMed 17349686Abrahamsson TR, Jakobsson T, Bottcher MF, Fredrikson M, Jenmalm MC, Bjorksten B, Oldaeus G. Probiotics in prevention of IgE-associated eczema: a double-blind, randomized, placebo-controlled trial. J Allergy Clin Immunol. 2007 May;119(5):1174-80. doi: 10.1016/j.jaci.2007.01.007. Epub 2007 Mar 8.
- Background: PubMed 3365007Barr RG, Kramer MS, Boisjoly C, McVey-White L, Pless IB. Parental diary of infant cry and fuss behaviour. Arch Dis Child. 1988 Apr;63(4):380-7. doi: 10.1136/adc.63.4.380.
- Background: 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.
- 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 18492520Indrio F, Riezzo G, Raimondi F, Bisceglia M, Cavallo L, Francavilla R. The effects of probiotics on feeding tolerance, bowel habits, and gastrointestinal motility in preterm newborns. J Pediatr. 2008 Jun;152(6):801-6. doi: 10.1016/j.jpeds.2007.11.005. Epub 2007 Dec 26.
- Background: PubMed 25090301Indrio F, Di Mauro A, Riezzo G. Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation--reply. JAMA Pediatr. 2014 Aug;168(8):778. doi: 10.1001/jamapediatrics.2014.368. No abstract available.
- Background: PubMed 11316682Lucassen PL, Assendelft WJ, van Eijk JT, Gubbels JW, Douwes AC, van Geldrop WJ. Systematic review of the occurrence of infantile colic in the community. Arch Dis Child. 2001 May;84(5):398-403. doi: 10.1136/adc.84.5.398.
- 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 15693915Savino F, Bailo E, Oggero R, Tullio V, Roana J, Carlone N, Cuffini AM, Silvestro L. Bacterial counts of intestinal Lactobacillus species in infants with colic. Pediatr Allergy Immunol. 2005 Feb;16(1):72-5. doi: 10.1111/j.1399-3038.2005.00207.x.
- Background: PubMed 17200238Savino F, Pelle E, Palumeri E, Oggero R, Miniero R. Lactobacillus reuteri (American Type Culture Collection Strain 55730) versus simethicone in the treatment of infantile colic: a prospective randomized study. Pediatrics. 2007 Jan;119(1):e124-30. doi: 10.1542/peds.2006-1222.
- Background: PubMed 24796800Steutel NF, Benninga MA, Langendam MW, de Kruijff I, Tabbers MM. Reporting outcome measures in trials of infant colic. J Pediatr Gastroenterol Nutr. 2014 Sep;59(3):341-6. doi: 10.1097/MPG.0000000000000412.
- Background: PubMed 24690625Sung V, Hiscock H, Tang ML, Mensah FK, Nation ML, Satzke C, Heine RG, Stock A, Barr RG, Wake M. Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial. BMJ. 2014 Apr 1;348:g2107. doi: 10.1136/bmj.g2107.
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.
Ting Zhang, MD principal investigator
Shanghai Children's Hospital
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 people with Crying Time in Colicky Infants, run by Shanghai Children's Hospital at 1 site in China.
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 10 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: status not confirmed, as of the sponsor's last update on 31 Oct 2016. 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 China. 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 Ting Zhang, MD (+86 18016487615, zhangt@shchildren.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily crying time will be measured at Day 7 through questionnaire finished by parents. (time frame: Day 7). The study lists 3 primary outcomes in all. 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 NCT02574065, which also lists 15 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 31 Oct 2016; AzTrials last refreshed its copy on 31 Oct 2026.