A Large-Scale Study To Describe The Prevalence, Characteristics and Management of Functional Gastrointestinal Disorders in African Infants

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Received: 23 October 2019 Revised: 3 February 2020 Accepted: 5 March 2020
DOI: 10.1111/apa.15248
REGULAR ARTICLE
A large-scale study to describe the prevalence, characteristics

and management of functional gastrointestinal disorders in
African infants
Marc Bellaiche1 | Simon Ategbo2 | Fanny Krumholz3 | Thomas Ludwig4 |

Mohamad Miqdady5 | Abdelhak Abkari6 | Yvan Vandenplas7
1
Paediatrics Gastroenterology Department,
Robert-Debré Hospital, Paris, France Abstract
2
Paediatics Department, Angondjé Hospital, Aim: To evaluate the pattern, impact on quality of life and management of common
Libreville, Gabon
functional gastrointestinal disorders (FGIDs) and related signs and symptoms in in-
3
Danone Nutricia Africa & Overseas,
Limonest, France
fants below 1 year of age in Africa.
4
Danone Nutricia Research, Singapore, Methods: Multicentre, cross-sectional, observational study in 10 African countries.
Singapore At the first paediatric consultation of children with gastrointestinal symptoms, the
5
Pediatric Gastroenterology, Hepatology
perception of paediatricians on FGIDs (infant colic, constipation and regurgitation)
and Nutrition Division, Sheikh Khalifa
Medical City, Abu Dhabi, United Arab and gas/bloating, impact on infant quality of life and parental anxiety and patient
Emirates
6
management practices were evaluated by standardised questionnaires.
Paediatrics Gastroenterology Department,
Ibn Rochd Hospital, Casablanca, Morocco Results: Questionnaires were completed by 759 paediatricians for 10 812 infants.
7
KidZ Health Castle, UZ Brussel, Vrije Overall, 49.9% of paediatricians reported ≥30% of first infant consultations each
Universiteit Brussel, Brussels, Belgium
month for FGIDs or related symptoms. Infant colic was most commonly diagnosed
Correspondence (57.6% of infants), followed by gas/bloating (43.2%), regurgitation (39.7%) and consti-
Yvan Vandenplas, KidZ Health Castle,
pation (31.4%). Overall, 53% presented >1 symptom. Mean scores for infant quality
UZ Brussel, Vrije Universiteit Brussel,
Laarbeeklaan 101, 1090, Brussels, Belgium. of life, sleep and parental anxiety were worse when children had multiple symptoms
Email: [email protected]
compared to children with a single symptom (P < .025). Prescription of medication
Funding information was common (62.4%). There were no consistent differences between countries.
The study was funded by Danone Nutricia
Conclusion: Functional gastrointestinal disorder occurrence in Africa was high with
Africa & Overseas, Limonest, France.
a gap between expert recommendation that emphasises parental reassurance and
nutritional advice and daily practice, particularly prescription of medication.
KEYWORDS
functional gastrointestinal disorder, infant, Africa, colic
Abbreviations: FGID, functional gastrointestinal disorder; QUALIN, quality of life in infants.
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction
in any medium, provided the original work is properly cited and is not used for commercial purposes.
© 2020 The Authors. Acta Paediatrica published by John Wiley & Sons Ltd on behalf of Foundation Acta Paediatrica.
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wileyonlinelibrary.com/journal/apa Acta Paediatrica. 2020;109:2366–2373.
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BELLAICHE et al. 2367
1 | I NTRO D U C TI O N
Key notes
It has been reported that the most frequent functional gastroin-
testinal disorders (FGIDs) (including regurgitation, infant colic and • The first large-scale study on functional gastrointestinal
constipation) affect approximately 50% of all infants during the first disorders (FGIDs) in Africa, showing incidences in con-
year after birth. 1,2
In France, FGIDs account for approximately 25% sultations of children with gastrointestinal complaints of
of paediatric consultations of infants up to 4 months of age. These 3 infant colic (57.6%), gas/bloating (43.2%), regurgitation
FGIDs have been reported to be associated with an adverse impact (39.7%) and constipation (31.4%), with 53% presenting
on the quality of life of both the infant and the family.3-8 more than one symptom.
Despite FGIDs frequently being individually reported, there is • Infant quality of life, quality of sleep and parental anxi-
evidence towards the frequent occurrence of more than one FGID in ety were adversely affected by FGIDs.
the same infant. 1,9,10
The exact prevalence of FGIDs, as well as their • A gap was identified between FGID management prac-
impact on infants and their families remains poorly defined, espe- tices and expert recommendations, particularly regard-
cially at the primary healthcare level. 2,11,12 ing over-prescribed medication.
Patient management should focus on parental reassurance and
nutritional advice.11,13-16 However, several European surveys have
suggested that paediatricians often address parental demands by a description and characteristics of the FGID or gas/bloating by the
adopting unnecessary practices such as performing extra investiga- paediatrician and the first intent patient management prescribed.
tions or prescribing medications.17-20 The questionnaires were completed from June to November 2017.
In Africa, the occurrence and impact of FGIDs have been very
poorly studied. This large-scale, non-interventional study was con-
ducted to characterise the occurrence of regurgitation, infant colic, 2.2 | Study assessments
functional constipation and gas/bloating in paediatric consultations
in African countries as well as to evaluate their impact on quality of The study objectives were to collect the perception of paediatricians
life of the infant and parental anxiety. Patient management practices on regurgitation, infant colic, functional constipation and gas/bloat-
were also recorded. ing and their consequences, to evaluate their relative frequency and
their impact on family quality of life, and to describe their manage-
ment in several African countries.
2 | M ATE R I A L S A N D M E TH O DS Paediatricians reported their clinical experience for cases of re-
gurgitation, infant colic, functional constipation and gas/bloating as
2.1 | Study design and participants well as the real-life characteristics associated with the symptom, in-
cluding quality of life, treatment and patient management.
This was a multicentre, observational study conducted in 10 countries Regurgitation and infant colic were assessed according to adapted
in Africa (Algeria [182 paediatricians], Morocco [203], Tunisia [50], Rome IV criteria for clinical research.11 A certified French translation
Mauritius [28], Madagascar [38], Senegal [15], Gabon [35], Congo [39], of the description of infant colic and regurgitation based on the ROME
Ivory Coast [107] and Cameroon [62]). As a non-interventional study, criteria was used (Parléclair, France). Regurgitation was defined as
the visits and procedures were the community standard practice, and occurring at least twice per day for at least 3 weeks without nausea,
there were no procedures other than usual patient management and haematemesis, retching, apnoea, failure to thrive, difficulty in swal-
collection of specific data by questionnaires. The questionnaire was lowing or feeding or abnormal posture (Sandifer syndrome) in oth-
developed in consultation with African and international experts and erwise healthy infants aged 3 weeks to 12 months. Infant colic was
was designed to be as clear as possible regarding the terms and lan- defined as paroxysms of irritability, agitation or crying without any
guage understood and used by African paediatricians. obvious cause that lasted ≥3 hours per day and occurred ≥3 times in
Questionnaires were completed by the treating paediatricians 1 week, were unpredictable and inconsolable and were present before
following consultation of full-term, and otherwise healthy in- 5 months of age, without failure to thrive or fever. Functional consti-
fants (per clinical examination of the paediatrician) between 0 and pation was assessed differently from the Rome IV criteria according to
12 months of age presenting for the first time with functional gas- a definition for newborns as infrequent or difficult bowel movements
trointestinal symptoms as the main complaint, and who were not for more than 2 weeks without any organic cause.13,21 Information on
known to be allergic to cow's milk protein. Paediatricians were in- gas/bloating was recorded using parental reports of symptoms.
structed about FGIDs in advance of the study and questionnaires Quality of life and sleep assessments were completed for infants
included definitions for 3 FGIDs (infant colic, constipation and re- during the consultation using a scale extracted from the Quality of
gurgitation) and 1 symptom (gas/bloating). The questionnaires were Life in Infants (QUALIN) questionnaire validated for paediatricians. 22
used to collect data on professional practice experience of each in Additionally, parental anxiety was assessed using a visual analogue
this patient population, and on the individual patient cases, including scale.
|
2368 BELLAICHE et al.
2.3 | Statistical analyses Infants' families represented a range of socio-economic back-

grounds. Most fathers were employed (97%) compared with 49%
Continuous variables were described by the number of observa- of mothers. For both fathers and mothers, the highest percentage
tions, the mean, standard deviation, median, inter-quartile range, worked as employees (33% and 18%), followed by executive level
minimum and maximum. Categorical variables were described using employment (21% and 13%), and artisans (19% and 8%). Most infants
the frequency of infants by category. Missing data were not replaced were from urban areas, with only 5% of fathers and 1% of mothers
and were not imputed for inclusion in the data analyses. An arbi- working as farmers.
trary sample size of 10 000 infants was targeted, to be included by
approximately 900 paediatricians with each paediatrician having a
2-month period to include 12 infants. Statistical comparisons were 3.2 | Characteristics of functional
performed using two-sided chi-square tests with a type I error and a gastrointestinal symptoms
significance level of α = .05. All statistical analyses were performed
by Groupe Axonal-Biostatem, France, using SAS® version 9.4. The data for each country are shown in Figure 2 as well as for the
overall population for each symptom. Overall, infant colic was most
commonly reported (57.6% of infants), followed by regurgitation
3 | R E S U LT S (39.7%) and constipation (31.4%; Figure 2). Gas/bloating was re-
ported for 43.2% of the infants. Despite certain country specificities
3.1 | Participants studied (eg regurgitation was slightly more frequent in Gabon, Madagascar
and Mauritius; colic was slightly more frequent in Algeria, Cameroon,
Questionnaires were completed by 759 paediatricians for a total of Senegal and Tunisia; constipation was slightly more frequent in
10 812 infants. Overall, 49.9% of paediatricians reported that ≥30% Congo, Gabon and Ivory Coast; and gas/bloating was slightly more
of first infant consultations each month were for functional gastro- frequent in Tunisia), there were no consistent trends.
intestinal symptoms. More than one FGID, or a combination of FGIDs with gas/bloat-
There was a similar number of male (50.5%) and female (49.5%) ing, were reported for 53% of infants. Only regurgitation, infant
infants. The overall mean ± SD age at onset of symptom(s) was colic, constipation and gas/bloating were reported for 26.7%, 34.1%,
6.6 ± 9.1 weeks and varied between countries being lowest in 25.2% and 14.0% of infants, respectively. For those with more than
Cameroon (4.8 ± 6.5 weeks) and highest in Congo (13.1 ± 13.0 weeks) one FGID, or a combination of FGIDs with gas/bloating, the three
(Figure 1). Overall, mean ± SD age at the time of consultation was lon- most frequent combinations were colic and gas/bloating (24.4%),
gest for constipation (16.4 ± 13.5 weeks), being shorter for gas/bloat- colic and regurgitation (14.9%) and regurgitation, colic and gas/
ing (12.2 ± 11.4 weeks), regurgitation (12.0 ± 10.8 weeks) and infant bloating (14.2%), as reported in Table 1.
colic (10.5 ± 10.1 weeks). Mean ± SD weight at the time of consultation
was 5.4 ± 1.7 kg, and 65% of infants were delivered vaginally.
Overall, 90.8% of infants had been breast-fed. At the time of 3.3 | Infant quality of life and sleep and
evaluation for functional gastrointestinal symptoms, 27.2% of in- parental anxiety
fants were still exclusively breast-fed, 47.7% were fed breast milk
and infant formula, 19.4% were fed infant formula exclusively, while The overall mean ± SD score for infant quality of life was 6.1 ± 2.0 on
5.7% were fed either cow's milk, other animal milk or a vegeta- a scale of 1 (very bad) to 10 (excellent), with 23.4% having a score ≤ 4
ble-based drink exclusively or as a supplement to breast milk and/ (bad or very bad). The mean ± SD score was worse for infants with
or infant formula. more than one FGID symptom than for those with a single symptom
16
14
Age at FGID onset (weeks)
12
10
0
F I G U R E 1 Infant age (mean ± SD) at
onset of FGID by country (N = 9864).
FGID, functional gastrointestinal disorder
|
A Regurgitation
100
28.5 31 35.2
80 41.4 45.6 46.3 41.6 46.6 45 47.7 39.7
60
40
71.5 69 64.8
58.6 54.4 53.7 58.4 53.4 55 52.3 60.3
20
B Colic
100
80 42.4 45.2 37
57.6 50.5 57.6
61.9 66.8 60 66.7 64.3
60
40
57.6 54.8 63
20 42.4 49.5 42.4
38.1 33.2 40 33.3 35.7
0
C Constipation
100
25.3 29.8 22.6 27.8 29.8 29 31.4
80 44.8 40.6 37.5
48.1
60
40 74.7 77.4 72.2

70.2 70.2 62.5 71 68.6
51.9 55.2 59.4
20
D Gas/bloating
100
27.7 29.5 34.1
80 45.4 46.3 39.7 43.5 42.7 43.2
49.3 53.7
60
40 72.3 70.5 65.9

54.6 53.7 60.3 56.5 57.3 56.8
50.7 46.3
20
No Yes
F I G U R E 2 Percentage of patients with FGID symptoms (regurgitation, colic and constipation) and gas/bloating by country (N = 10 458).
FGID, functional gastrointestinal disorder
|
TA B L E 1 Incidence of combined FGID symptoms (regurgitation, by 95.4% of paediatricians), followed by advice to parents
infant colic and constipation) and gas/bloating (N = 5532) (87.6%). Prescription of medication was, however, a very com-
Symptoms % mon practice (61.8%). Infant formula was changed in 43.5% of
cases (data not available for the detail of the change of formula).
Two symptoms
In each case, the percentage of paediatricians adopting each
Infant colic, gas/bloating 24.4
patient management practice (ie parental reassurance, advice,
Infant colic, regurgitation 14.9
prescribed medication and change of formula) was higher for
Infant colic, constipation 10.0
infants with more than one FGID symptom (N = 5532) than for
Gas/bloating, regurgitation 9.6 those with a single symptom (N = 4926) for parental reassurance
Gas/bloating, constipation 7.0 (96.1% vs 94.7%), advice to parents (89.6% vs 85.3%), medication
Regurgitation, constipation 3.6 (68.7% vs 54.1%) and change of infant formula (48.1% vs 38.3%)
Three symptoms (P < .001; Figure 3A). Of those who were prescribed medication,
Infant colic, gas/bloating, regurgitation 14.2 42% were prescribed more than one treatment, and the number
Infant colic, gas/bloating, constipation 7.4 of prescribed treatments was higher for infants with more than
Infant colic, regurgitation, constipation 2.3 one FGID symptom (mean ± SD 1.5 ± 0.7 treatments) than for in-
Gas/bloating, regurgitation, constipation 1.3 fants with a single FGID (mean ± 1.2 ± 0.5 treatments; P < .001).
The most commonly prescribed drugs included antispasmodics
Four symptoms
(43.9% of patients), laxatives (28.0%), prokinetics (13.2%), antac-
Infant colic, gas/bloating, regurgitation, constipation 5.3
ids (5.6%) and combinations of these and other prescription med-
Note: Data are % for the subpopulation of infants for whom more than 1 ications. Table 3 shows the distribution of medication by FGID or
symptom was reported.
gas/bloating. Antacids, protein-pump inhibitors, and prokinetics
Abbreviation: FGID, functional gastrointestinal disorder.
and anti-H2s were most commonly used for regurgitation; anti-
spasmodics were most commonly used for infant colic; treatment
TA B L E 2 Patient quality of life, sleep and parental anxiety against intestinal gas was most commonly used for gas/bloating;
and oral laxatives and laxative enemas were most commonly used
1 symptom >1 symptom Overall P value*
for constipation.
Infant 6.3 ± 2.1 5.9 ± 2.0 6.1 ± 2.0 <.001
The patient management practices not including parental reas-
quality
surance were similar for each type of FGID symptom, and combined
of life
practices were more common than single practices (Figure 3B).
Infant 6.5 ± 2.2 5.9 ± 2.1 6.1 ± 2.2 <.001
quality
of sleep
Parental 6.1 ± 2.2 6.2 ± 2.2 6.1 ± 2.2 .022 4 | D I S CU S S I O N
anxiety
Note: Data are mean ± SD for the subpopulation of infants for whom at This was the first large-scale study of the characterisation and man-
least 1 symptom was reported. agement of FGIDs in Africa. The study results confirm the occurrence
*Student's t test for the comparison of 1 symptom vs >1 symptom. of FGIDs in developing countries in Africa and showed FGIDs to be a
very frequent cause for consultation of infants aged 0-12 months in
(5.9 ± 2.0 vs 6.3 ± 2.1; P < .001; Table 2). The infants' quality of these countries. Notably, even in the country with the oldest cohort
sleep scores were similar to the quality of life scores, with an over- (Congo, mean age 13.1 weeks), infant colic was still diagnosed in ap-
all mean ± SD score of 6.2 ± 2.2 and being worse for infants with proximately 40% of patients. About half the paediatricians reported
more than one FGID, or a combination of FGIDs with gas/bloating that at least one out of three consultations were linked to FGIDs
(5.9 ± 2.1 v 6.5 ± 2.2; P < .001; Table 2). and related signs and symptoms. This is in agreement with studies in
The overall mean ± SD parental anxiety score was 6.1 ± 2.2 on a Europe and the US, which have shown a similar incidence of FGIDs
scale of 1 (very low) to 10 (very high), with 30.9% of parents having of 40%-60% in infants aged 0-12 months.1,14,21,23 Often more than
a score ≥8. Parental anxiety was lower for infants with one FGID one FGID symptom occurred together in the African infants in the
symptom than for those with more than one symptom (6.1 ± 2.2 vs present study, which again is in line with pre-existing data from other
6.2 ± 2.2; P = .022; Table 2). global regions,1,10,24 and the most common combination of symp-
toms was infant colic with gas/bloating which accords with a previ-
ous study conducted in France.3
3.4 | Patient management and treatment This study found an adverse impact of FGIDs on infant quality
of life, quality of sleep and parental anxiety, all of which were worse
The most common overall patient management practice for in- for infants with more than one FGID symptom. This reinforces the
fants with FGID symptom(s) was parental reassurance (reported importance of the paediatrician not only diagnosing and treating the
|
F I G U R E 3 Clinical management A P<.001

practices overall (A) in addition to 100 P<.001
parental reassurance by FGID symptom
(regurgitation, colic and constipation)
P<.001
and gas/bloating (B). FGID, functional 80
Paediatricians [%]
gastrointestinal disorder
P<.001
60
40
20
0
Parental reassurance Advice to parents Medication Change of infant formula
Overall >1 symptom 1 symptom
None
B
Gas/bloating (N = 4323) Advice to parents
Change of infant
formula
Constipation (N = 3098)
Change of infant
formula + medication
Medication
Colic (N = 5802)
Advice to parents +
change of infant formula
Regurgitation
Advice to parents +
(N = 3985)
medication
Advice to parents +
0% 20% 40% 60% 80% 100%
change of infant formula
+ medication
TA B L E 3 Medication used for FGID symptoms (regurgitation, infant colic and constipation) and gas/bloating
Regurgitation Infant colic Constipation Gas/bloating Total

(N = 2367) (N = 3996) (N = 2271) (N = 3114) (N = 6545)
Antacids 11.8 4.5 2.0 4.3 5.6

Protein-pump inhibitors & 7.8 2.8 1.2 2.6 3.6
anti-H2
Prokinetics 28.4 10.7 8.9 10.8 13.2
Antispasmodics 42.7 56.9 36.0 49.7 43.9
Treatment against intestinal 40.9 50.3 27.9 62.8 52.1
gas
Oral laxative 4.6 8.0 34.1 8.3 13.1
Laxative enema 5.5 9.7 37.6 10 14.9
Other 8.6 7.0 5.9 6.2 7.0
Note: Data are percentage of infants receiving the medication.

Abbreviation: FGID, functional gastrointestinal disorder.
infant but also taking into account parental anxiety11 and including was not collected in this survey. In particular, medication was pre-
this as a consideration in the overall management practice. scribed frequently (in >60% of cases where more than one symp-
All interventions were more common for infants with more than tom was present), constituting a deviation from expert guidance
one FGID, or a combination of FGIDs with gas/bloating. Other than which recommends minimal use of medication for the management
parental reassurance, clinical management more often involved of FGIDs13,14,16,21,25,26 and suggests that parental reassurance and
two or more approaches rather than a single practice and was sim- nutritional advice constitute the most effective management prac-
ilar for each FGID although information on extra investigations tice for FGIDs.16 It can be hypothesised that prescribing medication
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for infants is used at least in part as an effort to manage parental Singapore. The other authors have no conflict of interests to
anxiety. However, the prescription of medication in this way is not declare.
only unnecessary and has no supportive evidence, but can also be
associated with side effects and can have an impact on healthcare ORCID
expenditure. 27 Yvan Vandenplas https://orcid.org/0000-0002-1862-8651
Limitations of this study included that participating paediatricians
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16512227, 2020, 11, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/apa.15248 by Readcube (Labtiva Inc.), Wiley Online Library on [31/01/2023].

A large-scale study to describe the prevalence, characteristics

Marc Bellaiche1 | Simon Ategbo2 | Fanny Krumholz3 | Thomas Ludwig4 |

functional gastrointestinal disorder, infant, Africa, colic

Abbreviations: FGID, functional gastrointestinal disorder; QUALIN, quality of life in infants.

2.3 | Statistical analyses Infants' families represented a range of socio-economic back-

40 74.7 77.4 72.2

40 72.3 70.5 65.9

F I G U R E 3 Clinical management A P<.001

Overall >1 symptom 1 symptom

Regurgitation Infant colic Constipation Gas/bloating Total

Antacids 11.8 4.5 2.0 4.3 5.6

Note: Data are percentage of infants receiving the medication.

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