Comfort Next study

Overall gastrointestinal disorders (FGIDs) are very frequent in the infancy and early
childhood, and even if mostly they are transient and do not require a medical treatment,
they may be very distressing to a new parent as well as a child. Functional constipation
is the most common FGiD above 12 months of age and peaks when the toilet training
starts.

The prevailing consensus among experts is that a functional constipation in children
should not be treated with diet but once constipation occurs it should be treated with
pharmacological means. However experts also agree that proper balanced diets with
special focus on nutrients such as: fibers and fluid intake, should be an integral part of
the maintenance therapy as well as a prevention of constipation.

This study aims to examine how Friso Comfort Next: GUM (Growing UP Milk) formula is
performing in supporting the maintenance of good digestion in toddlers experiencing the
most common for this age group gastrointestinal disorder (FGID): constipation; against
comparable comfort product of a competitor.

In a parallel open label study with commercial product Total Comfort 2 as a
control/comparison, and Friso Comfort Next, otherwise healthy toddlers (12 till 32
months of age) referred to a paediatrician/ paediatric gastroenterologist with a functional
constipation (diagnosed based on Rome III criteria), after standard medical treatment
for constipation will receive two different Comfort Formulation.

Difference in maintenance of good digestion measured as normal stool consistency in
toddlers will be the primary outcome of the study. The difference will be measured
as the % of total reported hard stools (stool consistency) (Bristol Stool Chart I & II)
between study groups consuming different Comfort GUM products


The Secondary Outcomes will be as follows:

a) Stool frequency (as number of defecations per week).

b) GI tolerance questionnaires QPGS-RIII section E – once a week.

c) % of subjects reporting any hard stools.

d) Modified crying diary, reluctance to defecate/go to potty or toilet- questions will
be added to the Bristol stool chart to provide information if defecation was painful
and if child was crying/avoiding etc.

e) number of doctor’s visits of child in intervention period, number of prescribed
laxatives in intervention period (as a measure of relapse).

Group receiving Friso Comfort Next (with milk fat and mixture of different length prebiotics) will have a lower % of all hard stools reported during the 2-mo study period compared to another Young Child Formula (with partially hydrolysed whey protein, HMO, FOS, low lactose, no palm oil).

V0 - diagnosis with constipation, followed by standard pharmacological treatment, info about the study

V1 - (1 week), recruitment, signed ICF, baseline evaluation

V2; V3; V4 - every two weeks, home visits, filling in questionnaires

V5 - 8 weeks - end visit, final evaluation

The screening of children for the identification and recruitment of eligible ones will be conducted during the visit to a paediatrician related to experiencing hard stools and constipation. Toddlers who are diagnosed with constipation according to Rome III criteria will undergo a medicinal treatment as prescribed by their physician/paediatrician for constipation. The study will start after the treatment of the acute problem has been finished, constipation resolved and laxative decreased to the maintenance levels. The laxatives in decreasing dose will be provided during the first month of the study. During the second month there will be no laxatives provided, unless necessary due to relapse, which then will be considered as one of the outcomes parameters.

All toddlers meeting the inclusion criteria will be invited to join the study. After receiving the patient information file as well as the explanation of the trial objectives and set up, legal guardians of the children will be ask to sign informed consent form. All participants will also receive an information file on importance of proper intake of fluids and fibre rich foods for maintenance of the normal stool consistency. All participating toddlers will be randomly allocated to receive either Friso Comfort Next or another Comfort formula for the period of 2 months, which they will consume according to standard feeding tables provided by the respective manufacturer. During the intervention period parents will be asked to monitor the child’s digestion (stool consistency, defecation frequency) and digestive comfort parameters (comfort questionnaires, crying diaries) with use of different questionnaires and diaries. No biological samples will be collected at any time during this study. Number of doctors’ visits, their purpose and prescribed medication will also be registered. Overall anthropometric (body weight and length) measures will be collected at the beginning and end of the study.