Baby Biotics: Do probiotics help crying babies and their families?
| ISRCTN | ISRCTN95287767 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95287767 |
| Protocol serial number | N/A |
| Sponsor | Murdoch Childrens Research Institute (MCRI) (Australia) |
| Funder | Murdoch Childrens Research Institute, Royal Children's Hospital Melbourne (Australia) - Centre for Community Child Health |
- 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
Plain English summary of protocol
http://www.rch.org.au/uploadedFiles/Main/Content/ccch/Baby_Biotics_FAQs.pdf
Contact information
Scientific
Centre for Community Child Health
Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomised double-blind placebo-controlled intervention trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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(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) studied | 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 |
| 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 |
| Key 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 |
| Completion date | 01/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 3 Months |
| Sex | All |
| Target sample size at registration | 160 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 30/05/2011 |
| Date of final enrolment | 01/09/2012 |
Locations
Countries of recruitment
- Australia
Study participating centre
3052
Australia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
