Condition category
Pregnancy and Childbirth
Date applied
27/09/2010
Date assigned
25/10/2010
Last edited
03/02/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Valerie Sung

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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

On 10/12/2012 the overall trial end date was changed from 03/12/2012 to 01/05/2013.

Ethics approval

Human Research Ethics Committee of the Royal Children's Hospital, Melbourne – approval pending as of 17/08/2010 (ref: HREC #30111)

Study design

Single-centre randomised double-blind placebo-controlled intervention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Infant colic

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Mean infant crying time (minutes per 24 hours), measured by the Barr diary, a validated measure of infant crying, at 28 days

Secondary outcome measures

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

Overall trial start date

30/05/2011

Overall trial end date

01/05/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

160

Participant 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

Recruitment start date

30/05/2011

Recruitment end date

01/09/2012

Locations

Countries of recruitment

Australia

Trial participating centre

Centre for Community Child Health
Melbourne
3052
Australia

Sponsor information

Organisation

Murdoch Childrens Research Institute (MCRI) (Australia)

Sponsor details

Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia
-
mcri@mcri.edu.au

Sponsor type

Research organisation

Website

http://www.mcri.edu.au

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24690625

Publication citations

  1. Results

    Sung 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, 348, g2107.

Additional files

Editorial Notes