Probiotics to Decrease Infant Crying

Jamie Hilbert, RN, FNP student

Georgetown University
NURO 540-120
Purpose Table of Evidence
Change Model
Practice Recommendation
The purpose of the research was to determine if
probiotics were effective in decreasing infant crying,
enough to recommend them to parents in a clinic
setting.
PICOT Question
Search
References and Article
Grading criteria available on
handout
In infants how does probiotics compared to standard
care affect length of crying?
Research revealed, a strong level of evidence, that
breastfed infants with colic given L. reuteri had
decreased duration of crying (A). Additionally, clinically
significant reductions in crying duration was seen in
formula-fed infants using L. reuteri (B).
Recommendation that both formula-fed and breastfed
infants presenting with symptoms consistent with colic,
should be offered to try supplementation with L. reuteri
probiotic for two weeks.
Lactobacillus reuteri, drops are available at pharmacies
(Walgreens) under name brand, Gerber Soothe Colic
Drops at approximately $28 for a 2 week supply. A
dosage of 5 drops per day, equaling 100 million (10^8)
colony forming units should be recommended.
Encouraging mothers that are breastfeeding that
decreasing their consumption of cows milk may further
decrease infant crying.
Remind parents that colic is usually a self-limiting
problem that resolves by 4 -5 months of age, therefore
supplements will not need to be given long-term.
All infants should be followed up with to determine if
outcomes were met with treatment. Infants not showing
improvement after 2 weeks should be re-assessed to
ensure accurate diagnosis.
Increased parent satisfaction and decrease in parent
stress related to decreased infant fussiness.
Improved parent communication with provider through
updated resources, follow up visits and feedback on
surveys.
Image improvement with use of complementary
medicine therapy treatment with patients/parents.
Summary of Problem
Infant colic affects approximately 20% of infants
less than 3 months (Sung, et al. 2013).This is a
distressing time for parents that might lead to abuse
due to inability to cope with persistent crying.
Currently there is no reliable treatment of colic with
much of the recommendations to parents being
supportive therapies. The persistence of colic may
translate to a negative maternal-infant bond, decrease
in family quality of life, as well as infant injury(Sung et
al., 2013). Finding a reliable treatment for parents
caring for infants is needed to reduce infant distress
and promote parent bonding.
Ethical challenges in regards to infants being a
vulnerable population, which is unable to care for
themselves. Therefore interventions with infants
should be taken with great care to ensure provision of
safety have been maintained.
Databases: CINAHL, Medline Ovid, Medline PubMed,
and Google Scholar
Search Terms: Infant colic, probiotics, bifidobacterium
Inclusion Criteria: Articles written in English, primary
studies, formula and breastfed infants, published
between years 2004 2014.
Exclusion Criteria: reviews of studies, articles not
studying crying times, or using adults or children.
Results: 9 randomized control trials as well as 2
systematic reviews/meta-analysis
Practice Change
Change Strategies
EBP Evaluation
Practice Implications
Article Citation Summary
Level of
Evidence*
Savino et al. (2007)
Randomized control trial of 90 breastfed infants, <90 days,
using probiotic, L. reuteri verses simethicone. Results were
statistically significant decreases of 58 min., crying time for
probiotic group after 14 days. 95% were responders to
treatment at 28 days, in probiotic group.
2
Szajewaka et al.
(2013)
Double-blind randomized control study of L. reuteri verses
placebo using 82 full-term, <5 mos. with colic, with breastfed
and <50% formula-fed infants. Statistically significant cry time
reductions seen at 14 days, difference of 45 min. with RR 4.3
and NNT 2.
1
Sung et al. (2014)
Double-blind randomized control trial, of L. reuteri verses
placebo,167 healthy term infants <13 weeks, breastfed or
formula-fed with colic, studied for 6 mos. At 1 mo. probiotic
group cried more than placebo group. Cry time reductions were
seen, yet 8% greater reduction in crying with placebo group.
2
Savino et al. (2010)
Double-blind randomized control trial of L. reuteri verses
placebo, in 50 breastfed infants with colic. After 21 days median
cry times reductions were statically significant at 35 min/day. 20
were considered responders to treatment verses 8 in placebo
group.
1
Indrio et al. (2014)
Prospective double-blind study using 554 infants less than a wk.
old, comparing L. reuteri to placebo for 90 days. After a month
the probiotic infants decreased the length of crying at 45
min/day verses placebo at 96 min/day.
2
Coccorullo et al.
(2010)
Prospective double-blind study using 44 formula-fed infants (< 6
mos.) with constipation comparing probiotic (L. reuteri) verses
placebo. Probiotics did increase the frequency of stools. Crying
was increased in probiotic group, yet not that was statistically
significant (p = 0.02).
2
Mentula et al. (2008)
Randomized control pilot study using 18 breastfed colicky
infants (3-6 wks. old), using probiotics (L. rhamnosus strains)
verses placebo. Mean cry lengths decreased after two weeks
with probiotics, from 4.3 hrs./wk. and 7.6 hrs. with placebo from
baseline. Yet, findings were not statistically significant.
2
DuPont et al. (2010)
Prospective double-blind study using a probiotic (L. rhamnosus)
formula verses placebo in 66 colicky infants (3 wks. 3 mos.)
for 1 month. Irritability and agitation decreased with probiotic
group, cry length decreased as well at 53.2 min compared to
placebo at 21.1 min. However, the decrease was not statistically
significant.
2
Partty et al. (2013)
Double-blind randomized control trial comparing prebiotics, to
probiotics (L. rhamnosus), and placebo, using 94, 1-3 days old,
preterm infants (32-36 wks.). At 2 mos. old, 29% were
excessive criers, with prebiotic and probiotic groups having 19%
frequent criers compared to 47% in placebo group. Reductions
in cry times were seen in both probiotic and prebiotic groups.
2
Anabrees et al.
(2013)
Systematic review of randomized or quasi-randomized studies
comparing probiotics with a placebo or other control, in infants
<4 mos. with colic. Search produced 3 studies all using L.
reuteri (listed above), and reviewed by 2 independent
reviewers. Meta-analysis of 3 studies found probiotics
decreased crying times by almost a hour, with mean difference
of 56.03 min. A sensitivity analysis was done and heterogeneity
maintained consistent with similar reduction to crying times at
21 days, with mean difference of 55.48. Recommendation was
in favor of probiotics.
2
Sung et al. (2013)
Systematic review with meta-analysis using Cochrane
Handbook for Systematic Reviews, including randomized
studies using infants with colic and studying crying duration. A
significantly heterogeneous sample of 12 studies was used, and
3 studies for meta-analysis, compiling data from1825 infants.
Results were that L. reuteri in breastfed infants with colic
reduced cry time be day 21 with mean difference of 65.10
min/day compared to placebo. Random effects model taking
into account heterogeneity showed similar results. Findings
were ultimately unclear to probiotics effects partly due to
sample heterogeneity and lack of objective assessment tool.
2
Precontemplation
Contemplation
Preparation Action
Maintenance
Transtheoretical Model of Health Behavior Change
(Melnyk & Fineout-Overholt 2011)
1. Precontemplation
Hold a meeting with key stakeholders (i.e. providers,
nurses, staff) to gather information and determine
current recommendations for infant colic.
2. Contemplation
Determine potential obstacles/barriers to change.
Determine necessary resources needed to benefit
transmission of information to parents/caregivers.
3. Preparation
Develop new patient education materials for addition
to end of visit summary pages.
Determine facilitators of change that are front runners
and champions for change.
Secure coupons and financial assistance materials for
parents/caregivers to acquire probiotics.
Determine which local pharmacies carry L. reuteri to
provide those resources to parents.
4. Action
Provide resources and guidance, for clinic visits, to
give to parents presenting with colicky infant.
Send out a post treatment survey to determine
parent/caregiver satisfaction with treating colic with
probiotics.
Ask during follow up visits and well child checks if
treatment was successful, and ensure safety of use.
5. Maintenance
Meet with staff and determine satisfaction with
practice change. Brainstorm solutions to persistent
obstacles, promote ownership.
Share practice change successes and parent
feedback with staff.
Extend practice change to other clinic locations within
organization.
Surveys mailed out to families seen for colic, at infants 6
month birthday, requesting information on satisfaction,
perceived improvement using probiotics and any
potential barriers or negatives.
Tracking of outcome data from EMR for number of follow
up visits until 1 year of age. Whether patient stayed with
clinic, and if not why. Where health maintenance visits
kept and what were parents perceptions on colic in those
visits.