Page 149 - 15Diarrhoeaandvomiting

Diarrhoea and vomiting caused by gastroenteritis in children under 5 years

8.3.5 Fibre

Evidence overview
Two RCTs were included in this review. 190,191 One of the studies was conducted in Peru and
190
the other in the USA. 191 Both trials had two treatment arms. In total, they recruited 91 children
with acute diarrhoea.

One hospital-based RCT (n = 34) 190 examined the therapeutic effect of dietary fibre on the severity
and duration of acute watery diarrhoea. The study compared the effects of the administration of
a soy protein lactose-free formula with added fibre (0.6 g/ml) with the administration of a soy
protein formula without fibre in children. The participants were hospitalised male children aged
between 2 and 24 months suffering from acute diarrhoea for less than 96 hours. Although the
reported methods of randomisation were adequate, the allocation concealment was unclear.
A sample size power calculation was not given. The outcomes considered were duration of
diarrhoea (defined as the number of hours post admission until excretion of the last liquid or
semi-liquid stool not followed by another abnormal stool within 24 hours) and treatment failure
(defined as recurring dehydration above 5%, electrolyte disorders after initial rehydration or
important faecal output during intervention). [EL = 1−]
Comparability of the groups at study entry was adequate and the proportion of participants lost
to follow-up was 15%. The median duration of diarrhoea after hospitalisation was estimated at
43 hours in the intervention group and 163 hours in the control group. The authors reported
the difference as statistically significant (P < 0.003). The difference between the two groups for
treatment failure was not statistically significant.
One community-based RCT (n = 55) 191 assessed the efficacy of dietary fibre in reducing the
duration of watery diarrhoea in middle-class American children. The trial compared the effects
of feeding children aged under 24 months with a soy fibre supplemented infant formula for
10 days against a standard soy formula in shortening the duration of acute diarrhoea. Although
the reported methods of randomisation were adequate, the allocation concealment was unclear.
A sample size power calculation was not given. The main outcome measured was mean duration
of diarrhoea. [EL = 1−]
Comparability of the groups at study entry was adequate and the proportion of participants lost
to follow-up was 25%. Results were stratified by age over or under 6 months. When comparing
the two study groups in children over 6 months in age, the authors found a statistically significant
difference that favoured the administration of formula with added fibre in shortening the duration
of the diarrhoeal episode. The mean duration of diarrhoea was 9.7 hours in the intervention group
and 23.1 hours in the control group (P < 0.05). The difference was not statistically significant when
they compared the mean duration of diarrhoea in infants younger than 6 months. The authors
reported for all children that there was no statistically significant difference in the duration of
diarrhoea between the children formula-fed with added dietary fibre (12.2 hours) and the ones
fed with no added fibre (16.9 hours).

Evidence summary
There was a lack of high-quality evidence on the clinical effectiveness of administering soy protein
formula with added fibre in children with acute diarrhoea. Data from one RCT located in Peru
[EL = 1−] showed a statistically significant reduction in the duration of diarrhoea but no difference
in the number of treatment failures between the group receiving the fibre supplementation and
the control group. Another RCT conducted in the USA [EL = 1−] suggested that, in children aged
over 6 months, supplementation with fibre shortened the duration of diarrhoea by more than
12 hours. However, no statistically significant effect was observed in the combined group (under
and over 6 months of age) or in children younger than 6 months.

GDG translation from evidence to recommendation

Many of the studies on the effectiveness of micronutrients and vitamins in the treatment of
gastroenteritis were carried out in populations at risk of nutritional deficiency.

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