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The Journal of Pediatrics2015 doi:10.1016/j.jpeds.2014.11.039

Prevalence of functional gastrointestinal disorders in infants and toddlers

Miranda A.L. van Tilburg, PhD1, Paul E. Hyman, MD

2, Lynne Walker, PhD

3, Audra Rouster, MD

2,

Olafur S. Palsson, PhD1, Sung Min Kim, BA

1, William E Whitehead, PhD

1

1University of North Carolina, Center for Functional GI and Motility Disorders, Chapel Hill NC.

2Louisiana State University School of Medicine, Department of Pediatrics, New Orleans, LA.

3Vanderbilt University, Division of Adolescent Medicine and Behavioral Science, Nashville, TN.

Abbreviations: FGID=Functional gastrointestinal disorder; IBS=Irritable Bowel Syndrome; U.S.=United

States of America

Study support: The study was partly supported by the Rome Foundation.

Financial disclosure: Drs van Tilburg, Hyman, Palsson and Whitehead are part of the Rome committee

but did not receive any compensation for their involvement in the study. Dr van Tilburg wrote the first

draft of the manuscript and received no payment for doing so. The Rome foundation did not play a role in

study design, data collection/analyses, writing of the manuscript, or the decision to submit the manuscript

for publication

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Abstract

OBJECTIVES: It has been established that infant regurgitation and colic are common functional

gastrointestinal disorders (FGID) in infants. Little is known about the number of young children suffering

from other FGID. The purpose of the current study was to determine the prevalence of gastrointestinal

symptoms suggestive of an infant/toddler FGID as reported by parents in a representative community

sample.

STUDY DESIGN: 320 Mothers of children aged 0-3 years old were recruited nationwide in the U.S and

completed a questionnaire about their child’s and their own gastrointestinal symptoms.

RESULTS: Twenty-seven percent of infants/toddlers qualified for FGIDs by Rome criteria. Infant

regurgitation was the most common disorder in infants and functional constipation in toddlers. No age,

gender or race differences were found in FGID diagnoses. Compared to those who did not meet Rome

criteria, toddlers with FGID had lower quality of life (M=80.1 vs M=90.3, p<.001), increased medical

visits (M=0.38 vs 0.14; p <0.05), mental health visits (M=0.29 vs 0.06; p<0.05), and hospital stays

(M=0.35 vs 0.06; p<0.01). A child was more likely to suffer from hard stools if the parent also reported

hard stools (p= 0.02) but similar association was not found with loose stools.

CONCLUSION: FGIDs are common in infants and toddlers and can be identified in the general

population. They do not vary with gender and race. Quality of life is reduced in those with FGIDs. More

research is needed into these largely neglected conditions as it may improve the lives of a significant

number of young children.

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Introduction

Since the publication of the first Rome criteria in 1999 the number of scientific publications on functional

gastrointestinal disorders (FGIDs) in adults and children has increased rapidly(1) , but only a handful of

studies related to infants and toddlers(2-7). Prevalence of most FGIDs in infants and toddlers is largely

unknown. The two conditions for which most data exists are infant colic and regurgitation. Infant

regurgitation is common and depends on the age of the infant. It peaks around 2-4 months of age (67-

87%), followed by a rapid decline and is only present in about 4-8% of infants at 12 months of age(8-10).

Only one study has included the stricter Rome criteria, and found infant regurgitation in 0.7% of 1020

infants by pediatrician report(11). Estimates of prevalence rates for infant colic have ranged between 5-

19% depending on the sampling method and definition(12, 13). The purpose of the current study was to

determine the prevalence of gastrointestinal symptoms suggestive of an infant/toddler FGID as reported

by parents in a representative community sample.

Methods

Subjects

Subjects were mothers of children aged 0-18 years old recruited nationwide from respondents in all 50

states of the Unites State of America (U.S.), as well as DC and Puerto Rico. Subjects were provided by

Cint USA, Inc. (www.cint.com) and consisted of individuals who have joined online panels to answer a

variety of surveys (marketing, opinion polls, etc.). Quota-based sampling was used to ensure equal gender

composition for children and adequate representation of different age groups (infants, toddlers, children,

and adolescents), and race/ethnic groups. This manuscript focuses only on parents of children 0-3 years

old.

Mothers were approached to complete the survey about their child’s symptoms because: (1)

Mothers are more likely to be the primary person to communicate with physician about their children’s

symptoms; (2) Mothers are more often the primary caregiver and thus more likely to know about the

child’s symptoms; (3) The overlap between parental and child symptoms has mostly been studied in

mothers.

Design

Data collection was completed during the first two weeks of June 2013. Parents were invited to complete

a survey on ‘child health’. No information was given that the survey purpose was to examine gastro-

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intestinal symptoms, in order to avoid selection bias. All parents read an online consent form and

electronically accepted study enrollment, after which they completed a secure online survey conducted

with Qualtrics software. No identifying information was queried, so the survey was completely

anonymous. If parents had more than one child, parents were ask to answer all questions only about the

child whose name was first in an alphabetical order.

Several control measures were taken to identify and exclude multiple entries and inconsistent

reporting: (1) IP address check allowed only one response from each computer device, (2) Respondents

who were not consistent on three Rome questions that were repeated or showed other evidence of

indiscriminate responding, were eliminated, (3) mothers who lived less than half the time with their

children were excluded, as well as mothers of children with inflammatory bowel disease and cancer. This

study was approved by the Institutional Review Board of the University of North Carolina.

Questionnaires

Questionnaires assessing Rome criteria in child and parent, pediatric quality of life, demographics and

parent and child health history are described below.

Rome questionnaires

Currently, there is no validated diagnostic questionnaire for infant/toddler FGIDS although there is a

validated questionnaire for child and adolescent FGIDs (QPGS-RIII)(14-16). Therefore, we translated the

Rome III infant and toddler diagnostic criteria into a series of questions about symptoms that would be

easily understood by adults. Questionnaire items were constructed by the three of the authors (PH, AR,

MvT) and examined by 6 independent experts in FGID and questionnaire development including

physicians, and psychologists for understandability and face validity. Most responses were either Likert-

type scales or categorical responses. The resulting QPGS-RIII for infant/toddlers can be requested from

the authors.

Mothers also completed the Functional Bowel Module of the Rome III questionnaire for

adults(17), to assess their own symptoms. We only included the questions related to Irritable Bowel

Syndrome (IBS), Functional Dyspepsia, Functional Constipation, and Functional Diarrhea to limit

participant burden.

Quality of Life

Quality of life was measured with the PedsQL4.0 Generic Core Scale, which encompasses physical,

emotional, social and school/day care functioning(18). Items were transformed to a scale of 0-100, with

higher scores indicating better health related quality of life. Since the PedsQL is validated for children

ages 2 and up; data was collected for those children who were 2 and 3 years old.

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Demographic and health questions

Questions included age, gender and race/ethnicity of both mother and child, marital status, common

health problems, use of common medications, number of school/work absences in the past 6 months,

number of doctor’s visits in past 6 months, household income, and state of residence.

Analyses

Descriptive analyses were conducted to provide results, presented in means with standard deviations and

as percentages of the sample. T-tests provided comparisons between subgroups for continuous variables

or Chi2-tests for categorical variables. There was no missing data since the Qualtrics system required all

participants to complete each questions before being able to complete the next question.

Results

Sample description

A total of 1,447 mothers completed the survey of which 320 respondents provided information

about children 0-3 years old. A total of 264 (82.5%) were judged valid on all quality/validity checks and

were included in data analysis. Table 1 contains the general characteristics of this sample. Most

commonly endorsed physician diagnoses for mother were depression (11.7%), anxiety disorder (9.0%),

heartburn/GERD (9.0%), food allergies (6.0%), IBS (5.6%), and lactose intolerance (5.3%).

Rome diagnoses

Tables 2 and 3 show Rome diagnoses and answer distribution of the 8 main symptoms. More than one

quarter of children (27.1%) qualified for at least one FGID. All seven infant/toddler FGIDs occurred, with

infant regurgitation as the most common disorder in infants and functional constipation in toddlers (see

Table 2). Of the children with FGIDs, 79.2% qualified for only one FGID, 12.6% qualified for two, and

8.2% qualified for three or more FGIDs. There was no significant difference between boys and girls in

the number and kind of FGIDs. There were also no differences in the number and kind of FGID by

ethnicity and race. We did not examine race differences for infants below the age of 1 year old as most

race categories included less than 10 children.

Among mothers 34.6% met criteria for at least one FGID, with IBS being the most common (see

Table 2). Of mothers with FGIDs, 86.9% qualified for only one disorder, and 13.1% qualified for two

FGIDs.

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Medical visits and Quality of Life

Quality of life data was available for 123 children aged 2 and 3 years. Overall, the mean quality of life

score was comparable to healthy samples (see Table 1)(18). Parents rated quality of life as being lower in

children who qualified for FGIDs versus children who did not (M=80.1 vs M=90.3, p<.001).

The number of outpatient medical visits for gastrointestinal symptoms (M=0.38 vs 0.14; p <0.05),

mental health visits (M=0.29 vs 0.06; p<0.05), and hospital stays (M=0.35 vs 0.06; p<0.01) in the past 6

months were low but significantly higher in children with FGIDs compared to those without FGIDs.

Medication use (laxatives, anti-diarrheals, anti-acids, and suppositories/enemas) was significantly higher

in the FGID group (29.2%) compared to no-FGID group (11.3%, p <.001). There were no differences in

school or day care absences (M=4.42 vs M=5.15; p=0.77), but only 79 parents responded to this question.

Parents of children with FGIDs did not miss more days of work due their child’s illness than other parents

(M=0.82 vs M=0.55; p=.26).

Parent-child overlap

Chi2-test showed that children were not more likely to qualify for a FGID if their mother also qualified for

an FGID (31.4% of mothers of children without FGID vs 43.1% of mothers of children with FGID had

FGIDs themselves, p=0.08). Quality of life of the child was not affected by mother’s FGID status

(M=84.7 Mom FGID vs M=89.5 Mom no FGID, p > .05).

Since FGID differ in location and causes of the symptoms may vary between disorders, we

examined if child and parent are concordant for specific FGIDs. Two FGID diagnoses have comparable

diagnostic criteria in the infant/toddler and adult Rome criteria: Functional constipation and diarrhea. For

both disorders no instance was found where both mother and child qualified for that diagnosis by Rome

criteria. Therefore, we examined parent-child overlap in stool consistency. Watery, runny or mushy stools

were not more common in children of mothers with (31.5%) versus without (33.9%) loose stools at least

¾ of the time. Hard or very hard stools were more common in children whose mothers reported hard stool

more than 70% of the time (18.5% vs 8.4%; p =0.02).

Discussion

This is the first study to quantify the prevalence of infant and toddler FGIDs in the US. We included a

population of children, through parental report, from all U.S. states. The sample included a high

percentage of minorities, who have traditionally been underrepresented in studies on FGIDs. In this

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population-based study more than one quarter of infants and toddlers qualified for at least one of the

Rome diagnoses. These findings are consistent with studies among adults (e.g., (19, 20),(21)), and the

prevalence of these disorders was somewhat higher than in most studies including older children (e.g.,(7,

22, 23)), although at least one other population study has found similar prevalence rates in

adolescents(24).

Rates of regurgitation(8-10), colic(12, 13) and constipation(25) were similar to previous reports,

which did not use Rome criteria. Two population-based studies found very low prevalence and incidence

of infant regurgitation(7, 11), but these studies relied on pediatricians as reporters of the child symptoms.

The physician may not be knowledgeable about regurgitation if the family did not consult for this

symptom. On the other hand, the physician may have more information about other medical disorders

causing the symptoms than parents do. Almost no studies have examined the rates of the other FGIDs

specifically for this age group, including cyclic vomiting, functional diarrhea, infant dyschezia and infant

rumination syndrome. Our data showed that approximately 2% to 6% of infants and toddlers are afflicted.

We examined age and race differences in FGIDs. Prevalence of FGIDs was not different across

race and ethnicity. However, our sample was too small to examine race differences in infancy (below the

age of 1 years old). Although studies have generally found that girls are more likely to suffer from FGIDs

than boys(26, 27), we did not find such sex difference in our sample. However, it has been observed that

the gender difference in some FGIDs, such as abdominal pain, may not occur until puberty(26, 28) which

could explain why we found that boys and girls are equally likely to suffer from FGIDs as infants and

toddlers.

FGIDs had a measurable impact on infants and toddlers. Parents reported that their children with

FGIDs had lower quality of life, visited doctors more often and had more hospitalizations. These effects

have also been associated with FGIDs in older children and adults with FGIDs(29, 30) . Since infants and

toddlers go through many developmental milestones and continuous maturation of the brain and gut,

FGIDs in infancy and toddlerhood may have different origins and consequences compared to older

children. For example, colic and regurgitation are symptoms within the expected range of behavior for

healthy infants. Early life painful experiences have been found to increase the risk for developing FGIDs

later in life(31, 32) as well as other chronic pain disorders: A history of infant colic appears to be

associated with childhood migraine headaches(33). Thus, painful FGIDs in infancy improve as the child

matures, but they may also make the child more vulnerable to developing pain-related conditions later in

life. More data are needed on the development, maintenance, and (long-term) impact of FGIDs in infants

and toddlers.

It has previously been reported that functional abdominal pain and constipation in older children

and adolescents run in families(34, 35). We found some evidence for FGIDs to overlap between parent

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and child, but this difference only approached significance. Our sample may have been too small to show

a significant effect for these. On the other hand, FGIDs in this age group are very different from FGIDs in

adulthood. Common overlapping symptoms are stool consistency, and we found that mothers and

children tended to have hard stools in common. More research is needed to determine if and why

infant/toddlers are at heightened risk for FGIDs if there is a family history of FGIDs. Previous research

has suggested that both genes and social factors may play a role. There is evidence that children may

learn to respond to gastrointestinal symptoms based on how the mother responds to her own and her

child’s symptoms(34). Whether this type of learning plays a role in the transmission of FGIDs in infants

and toddlers has not yet been studied. On the other hand, mothers who have FGIDs may become

hypervigilant to notice these symptoms in their children and worry about their significance(36); this could

contribute to an increased prevalence of FGIDs in children because diagnosis was dependent on the

mother’s report of the child’s symptoms.

Our study has several limitations. First, our sample size was modest for a population-based study.

However, this is the first population-based study to examine the Rome criteria in this age group. Our

sample has good generalizability to the U.S. population as we sampled from all states, but studies in other

countries are needed to examine cultural and location differences in prevalence of FGIDs. Second, since

our study was a community survey we were not able to exclude possible medical causes for the reported

symptoms. This is a common issue in population-based studies. It has been reported that finding a

medical cause to explain the symptoms is very unlikely in older children who meet symptom criteria for

FGIDs(25, 37), and this is likely also the case in in infants and toddlers although data on this are not

available for that age range. Third, we used an unvalidated questionnaire since no suitable questionnaire

for assessing Rome-type symptoms existed for this age group. We took care, however, to develop it in a

manner similar to the QPGS-RIII, which measures child/adolescent Rome III criteria and has been widely

validated. Clearly, replication studies in larger samples are needed to overcome some of these limitations.

The use of online panels (through cint.com) may introduce several sources of bias. The American

Association for Public Opinion Research convened a taskforce in 2008 that indicated 2 main concerns38

.

Sample bias is a concern for online panels because up to 20% of the US population under the age of

65 years does not have internet access at home.39

However, traditional phone-based surveys have

increasingly been subject to even more sample bias as traditional landlines are removed from homes and

cell phone numbers are usually unlisted. The Center for Disease Prevention and Control reports 39.1% of

adults have access to wireless-only telephone service in 2013.40

In addition to not being able to reach the

participants, nonresponse rates may be a problem in online panels. One study found an average response

rate of 50% with some panels as low as 18% and others as high as 77%.41

However, nonresponse rate may

be equally low in phone interviews. Pew research center found the response rate to a typical phone survey

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to be only 25% in 2006 and dropping to 9% in 2012.42 and 43

Online panels may perform better on these

measurements with home access to the internet increasing in the US population.

Sample bias can be addressed by simple purposive sampling in which known information about

panel members is used to generate demographically balanced samples. We used such an approach by

directing the questionnaire to panelists of certain sex, age, race, and ethnicity, and used quota-based

sampling to ensure equal sex composition for children and adequate representation of different age groups

(infants, toddlers, children, and adolescents), and race/ethnic groups. This kind of purposeful sampling is

not available in phone interview sampling as no a priori information is available for the respondents.

A second source of bias in online panels is the quality of data. Some panelists are known to

complete large number of surveys and may answer screening questions in such a way to maximize

qualifying for the study. In addition, it is easy to complete these questionnaires quickly without much

thought to the questions (eg, randomly responding). According to the American Association for Public

Opinion Research report, the online panel industry, including Cint USA, has promoted online data quality

through an evolving set of standards such as validating panelists, eliminating duplicate members, or false

identities.38

We have also guarded data quality by having broad inclusion criteria, and eliminating people

with inconsistent responses and eliminating questionnaires from the same internet protocol address.

Even with our approaches to reduce bias and increase quality of the data it should be

acknowledged that findings from online panels often differs from panels through traditional methods

(such as phone interviews). Internet users may report higher rates of some health problems44

especially

those with low social desirability (eg, binge drinking). It is not certain if this is due to the mode of

administration (the internet is more anonymous and it has been suggested to elicit more honesty than face-

to-face interviews) or sampling bias/data quality. However, it indicates that the results of any study, using

either phone or online panels and including the current study, may be an imprecise estimate of the

population prevalence and needs to be supplemented by other forms of questionnaire administration.

In conclusion, this is the first study to examine the prevalence of FGIDs according to the Rome

III criteria in infants and toddlers. The current findings suggest that FGIDs are common in U.S. infants

and toddlers group, and are associated with lower quality of life and increased medical consultation. The

most common FGIDs in infants were regurgitation and colic while the most common FGIDs in toddlers

(ages 2-3) are functional constipation and functional diarrhea. Given our effort to include participants

from all 50 states and include minorities, who are usually not represented widely in FGID research, our

study has good generalizability to the US population of infants and toddlers. However, future studies are

needed with larger samples and non-US populations to confirm our findings on prevalence. Longitudinal

studies are also needed to determine whether FGIDs in infants and toddlers persist into childhood,

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adolescence, and adulthood. Research on these disorders in the earliest years of life is important as

treatment could benefit a large group of young children.

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14

Table 1: Sample characteristics

Child

Mean (SD) or %

Mother

Mean (SD) or %

Age 1.4 (1.2) 30.4 (6.2)

Gender (female) 47.7% 100%

Race/ethnicity

Hispanic 26.7%

Caucasian 56.8%

African American 12.0%

Asian 6.0%

Mixed or non-disclosed 24.7%

Hispanic 24.8%

Caucasian 62.4%

African American 11.7%

Asian 9.0%

Mixed or non-disclosed 14.2%

Cohabitation Lives with mother full-time 99.2% Married/cohabiting 82.3%

Household income < $25,000 22.2%

$25,000 - $50,000 31.6%

$50,000-100,000 31.6%

>$100,000 9%

Parental education (some) High school 16.5%

(some) college 71.4%

(some) graduate school 12%

Quality of Life 87.7 (15.3)

Table 2: Percentages of subjects meeting Rome III criteria based on symptom reports by mothers

Infants

<1 year of age

Toddlers

Age 1-3 years

Mother

Regurgitation

Colic

Dyschezia

Functional Constipation

Functional Diarrhea

Cyclic Vomiting Syndrome

Rumination

Functional Dyspepsia

IBS

25.9%

5.9%

2.4%

4.7%

2.4%

0.0%

2.4%

N/A

N/A

N/A

N/A

N/A

9.4%

6.4%

3.4%

1.9%

N/A

N/A

N/A

N/A

N/A

8.6%

8.3%

Not measured

Not measured

10.9%

11.3%

15

Table 3: Percentages of subjects reporting symptoms

Symptoms Answer categories

Irritable/

fussy/

cry*

No 0-3

hours

3-6

hours

6-9

hours

9-12

hours

12-15

hours

15-18

hours

18-21

hours

21-24

hours

52.4% 44.8% 2.1% 0% 0% 0% 0% 0% 0%

Spit-up/

vomit*

No ≤1x

week

2-3x

week

4-6x

week

1x/day 2x

day

3-10x

day

>10x

day

46.9% 18.2% 6.3% 2.8% 6.3% 9.8% 9.1% 0%

Struggle/

grunt/cry

before poop*

No <5

minutes

5-9

minutes

10-20

minutes

>20 minutes

65.0% 26.6% 6.3% 0.7% 0.7%

How often

poop?

1x/week 2x/week 3x/week 4x/week 5x/week 6x/week 1x/day 2x/day 3x/day

1.5% 3.8% 4.5% 4.5% 4.5% 4.2% 36.4% 27.7% 11.7%

What poops

usually like?

Very hard Hard Not too

hard/not

too soft

Very soft Runny Watery Do not

know

1.5% 6.8% 56.4% 27.4% 1.5% 4.5% 1.1%

Food comes

back into

mouth

Never 1x/day 2x/day 3x/day ≥4x/day

83.1% 11.7% 3.0% 1.1% 0.4%

Vomit or

retch again

and again

without

stopping

Never 1x/day 2x/day 3x/day ≥4x/day

88.0% 7.5% 1.9% 1.1% 0.8%

*Percentages are only for infants under the age of 1 years old.