8.3.5Fibre

Bibliographic informationStudy type and evidence levelStudy detailsParticipant characteristicsIntervention and comparisonOutcome measures, follow-up and effect sizeComments
Brown 1993190
location: Peru
setting: hospital
Study Type RCT

Evidence Level 1−
Total no. of patients
n = 34
Intervention group n = 19
Control group n = 15
Male children aged 2–24 months with acute diarrhoea for <96 hours
Exclusion criteria
systemic infection, dysentery, previous diarrhoea episode within the last 14 days, breast-fed >1 per day
Intervention
Soy protein lactose free formula + added fibre
Control
Soy protein lactose free formula
Comparison
Intervention vs control
Follow-up

Outcome
  1. mean duration of diarrhoea (h)
  2. mean stool output
  3. treatment failure
Effect size
  1. median duration of diarrhoea
    intervention gp 43 hours
    control gp 163 hours
    P = 0.003
  2. mean (sd) stool output 1st d hospitalisation
    intervention gp 84 (70)g/kg
    control gp 77 (46) g/kg
    *stool output declined significantly in both groups during subsequent days of follow-up but there were no significant differences reported between the two groups
  3. treatment failure
    intervention gp 4/19
    control gp 2/15
Funding
Pediatric Nutrition Research and Development Division of Ross Laboratories
UC Davis Clinical Nutrition Research Unit
Comments

*duration of diarrhoea=number of hours postadmission until excretion of the last liquid stool not followed by another abnormal stool within 24 hours
*Treatment failure=
recurring dehydration >5%, or electrolyte disorders after initial rehydration or faecal excretion >350 g/kg for 1 day, >250 g/kg for 2 consecutive days, or >100 g/kg on day 6 of treatment
-

Lost to follow-up:6/40

-

Method of randomisation: adequate

-

Baseline comparability of the two groups at the start of the study adequate

-

Allocation concealment unclear

Vanderhoof 1997191
location: USA
setting: community- based
Study Type RCT

Evidence Level 1+
Total no. of patients
n = 55
Intervention group n = 30
Control group n = 25
Infants <24 months with acute diarrhoea (≤3 days), ≥ watery stools/24 hours, or 3 times the normal number of stools in 24 hours

Exclusion criteria
Other GI disorders, infection disease
Intervention
Soy-fibre supplemented formula for the first 10 days
Control
Soy formula without fibre
For the first 10 days
Comparison
Intervention vs control
Follow-up
24 days (the study addressed first 10 days)
Outcome
  1. duration of diarrhoea
Effect size
  1. median duration of diarrhoea (h)
    Intervention group 12.2
    P > 0.5
    *infants > 6 months (n = 44)
    Intervention group 9.7
    P < 0.5
Funding
n.s.
Comments
Lost to follow-up:19/74
*55 infants completed the study, the analysis included 67.

Method of randomisation: random numbers

Baseline comparability of the two groups at the start of the study adequate

Double-blinded (assessor and patient)

Allocation concealment unclear

From: Evidence tables

Cover of Diarrhoea and Vomiting Caused by Gastroenteritis
Diarrhoea and Vomiting Caused by Gastroenteritis: Diagnosis, Assessment and Management in Children Younger than 5 Years.
NICE Clinical Guidelines, No. 84.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2009 Apr.
Copyright © 2009, National Collaborating Centre for Women’s and Children’s Health.

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