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Baby Biotics: Do probiotics help crying babies and their families?
ISRCTN ISRCTN95287767
DOI 10.1186/ISRCTN95287767
ClinicalTrials.gov identifier
EudraCT number
Public title Baby Biotics: Do probiotics help crying babies and their families?
Scientific title Impact 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
Acronym N/A
Serial number at source N/A
Study hypothesis In 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

Please note that as of 10/12/2012, the anticipated end date for this study was updated from 03/12/2012 to 01/05/2013.
Please also note that recruitment for this study ended on 01/09/2012.
Lay summary http://www.rch.org.au/uploadedFiles/Main/Content/ccch/Baby_Biotics_FAQs.pdf
Ethics approval Human Research Ethics Committee of the Royal Children's Hospital, Melbourne, pending approval as of 17th August 2010 (ref: HREC #30111)
Study design Single-centre randomised double-blind placebo-controlled intervention trial
Countries of recruitment Australia
Disease/condition/study domain Infant colic
Participants - inclusion criteria Infants 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
Participants - exclusion criteria 1. 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
Anticipated start date 30/05/2011
Anticipated end date 01/05/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 160
Interventions The 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.
Primary outcome measure(s) Mean infant crying time (minutes per 24 hours), measured by the Barr diary, a validated measure of infant crying, at 28 days
Secondary outcome measure(s) 1. 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
Sources of funding Murdoch Childrens Research Institute, Royal Children's Hospital Melbourne (Australia) - Centre for Community Child Health
Trial website http://www.rch.org.au/ccch/for_researchers/Baby_Biotics/
Publications
Contact name Dr  Valerie  Sung
  Address Centre for Community Child Health
Royal Children's Hospital
Flemington Road
Parkville
  City/town Melbourne
  Zip/Postcode 3052
  Country Australia
Sponsor Murdoch Childrens Research Institute (MCRI) (Australia)
  Address Royal Children's Hospital
Flemington Road
Parkville
  City/town Melbourne
  Zip/Postcode 3052
  Country Australia
  Email mcri@mcri.edu.au
  Sponsor website: http://www.mcri.edu.au
Date applied 27/09/2010
Last edited 10/12/2012
Date ISRCTN assigned 25/10/2010
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