Baby Biotics: Do probiotics help crying babies and their families?

ISRCTN ISRCTN95287767
DOI https://doi.org/10.1186/ISRCTN95287767
Secondary identifying numbers N/A
Submission date
27/09/2010
Registration date
25/10/2010
Last edited
03/02/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

http://www.rch.org.au/uploadedFiles/Main/Content/ccch/Baby_Biotics_FAQs.pdf

Study website

Contact information

Dr Valerie Sung
Scientific

Centre for Community Child Health
Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia

Study information

Study designSingle-centre randomised double-blind placebo-controlled intervention trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleImpact of Lactobacillus reuteri DSM 17938 on infant colic and parent mental health: a randomised double-blinded, placebo-controlled trial in breast and formula fed infants less than 3 months old
Study objectivesIn a double-blind, placebo-controlled randomised trial, we aim to determine whether the probiotic Lactobacillus reuteri DSM 17938 benefits infants less than 3 months old with infant colic by:
1. Reducing the duration and episodes of infant crying
2. Improving infant sleep
3. Improving maternal mental health
4. Improving infant and family functioning, and
5. Improving parent quality adjusted life years (QALY) as an indication of intervention cost-effectiveness

We also aim to reveal underlying pathophysiogical mechanisms in infant colic by investigating changes in:
6. Gut microbiota, and
7. Faecal calprotectin levels

We hypothesise that, compared to the placebo (control) group, benefits to the L reuteri (intervention) group at 7, 14, 21, 28 days and 6 months post-randomisation will include:
1. Lower mean daily crying time (primary outcome) and fewer daily crying episodes
2. Longer infant sleep duration
3. Better mean scores on a standardised measure of maternal mental health (1 and 6 months)
4. Better mean scores on a standardised measure of infant and family functioning (1 and 6 months), and
5. Better mean scores on a standardised measure of parent QALY (1 and 6 months), indicating the intervention to be cost-effective

We also hypothesise that the intervention will, at 1 month post-randomisation:
6. Induce changes in gut microbiota, and
7. Reduce faecal calprotectin levels

On 10/12/2012 the overall trial end date was changed from 03/12/2012 to 01/05/2013.
Ethics approval(s)Human Research Ethics Committee of the Royal Children's Hospital, Melbourne – approval pending as of 17/08/2010 (ref: HREC #30111)
Health condition(s) or problem(s) studiedInfant colic
InterventionThe intervention is Lactobacillus reuteri DSM 17938 at the concentration of 0.2 x 10^8 cfu in an oil suspension. It is administered orally to each infant as 5 drops per day (total dose 1 x 10^8 cfu/day), for 28 days.

The control is a placebo, which is identical to the intervention but without Lactobacillus reuteri DSM17938. It is also administered orally to each infant as 5 drops per day for 28 days.

The follow-up period is 6 months.
Intervention typeOther
Primary outcome measureMean infant crying time (minutes per 24 hours), measured by the Barr diary, a validated measure of infant crying, at 28 days
Secondary outcome measures1. Mean infant crying time (minutes per 24 hours), measured by the Barr diary, a validated measure of infant crying, at 7, 14, 21 days and at 6 months
2. Mean number of episodes of infant crying per 24 hours, measured by the Barr diary, a validated measure of infant crying, at 7, 14, 21, 28 days and at 6 months
3. Mean infant sleep duration (minutes per 24 hours), measured by the Barr diary, a validated measure of infant sleep duration, at 7, 14, 21, 28 days and at 6 months
4. Mean maternal mental health scores, measured by the Edinburgh Postnatal Depression Scale, with higher scores indicating more symptoms of depression, at 1 and 6 months
5. Mean infant and family functioning scores, measured by the PedsQL Infant and Family Impact scores, with higher scores indicating better functioning, at 1 and 6 months
6. Mean parent quality adjusted life years (QALY) scores, measured by the AQoL-4D, a 12-item validated questionnaire to assess QALY and subsequently intervention cost-effectiveness, at 1 and 6 months
7. Infant faecal microbiota diversity, measured by 16S RNA amplification, at 1 month
8. Infant faecal calprotectin levels, measured by ELISA, at 1 month
Overall study start date30/05/2011
Completion date01/05/2013

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit3 Months
SexBoth
Target number of participants160
Key inclusion criteriaInfants less than 3 months old (up to and excluding 13.0 weeks) with:
1. Infant colic, ie crying more than 3 hours/day for more than 3 days over 7 days (as defined by the modified Wessel's criteria) by caregiver's report
2. More than 36 weeks gestation at birth
3. Birth weight more than 2500 g
Key exclusion criteria1. Infants with failure to thrive (weight gain less than 20 g/day averaged from birth to the last recorded weight)
2. Infants with major medical problems (eg. ill, immunocompromised, infants with major developmental or chromosomal abnormalities)
3. Infants or breastfeeding mothers using antibiotics or probiotics at the time of study recruitment
4. Families with insufficient English to understand informed consent or complete questionnaires
Date of first enrolment30/05/2011
Date of final enrolment01/09/2012

Locations

Countries of recruitment

  • Australia

Study participating centre

Centre for Community Child Health
Melbourne
3052
Australia

Sponsor information

Murdoch Childrens Research Institute (MCRI) (Australia)
Research organisation

Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia

mcri@mcri.edu.au
http://www.mcri.edu.au
ROR logo https://ror.org/048fyec77

Funders

Funder type

Research organisation

Murdoch Childrens Research Institute, Royal Children's Hospital Melbourne (Australia) - Centre for Community Child Health

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2014 Yes No
BMC - Part of Springer Nature Springer Nature