Birth Weight <2500gm Clinical Trial
Official title:
Promoting Healthy Foetal and Post Natal Growth by Modulating Vaginal or Gut Micro Biota With Supplementation of Prebiotic Agent ( Fructooligosaccharide) in Pregnant Women- a Randomized Double Blind Community Based Clinical Trial.
More than 20 million infants worldwide, representing 16 per cent of all births, are born with
low birth weight, 96 per cent of them in developing countries. Bangladesh having one of the
highest incidence rate (21.6%) in the world.The short-term consequences of LBW is 12 times
higher perinatal mortality. It is estimated that LBW causes 60 to 80 % of neonatal deaths.
For the survivors, the effects are long lasting and largely irreversible. Infants born LBW
are at 2-4 times greater risk to develop acute diarrhea, pneumonia or acute respiratory tract
infection than their normal birth weight counterparts. Adults born with LBW suffer increased
risk of high blood pressure, coronary heart disease (CHD), non insulin dependent diabetes
mellitus, obstructive lung diseases, or renal damage.
Genitourinary (GU) infection, as a major risk factor for low birth weight deliveries
affecting a very large number of women both in the industrialized and the developing world.
In Bangladesh, there was a high incidence of UTI in 21-25 years age group (44.61%). The
bottom line for GU infection is that lactobacilli, healthy bacteria lose their dominant.
Recently, the protective role of the commensal microbiota has come into focus for its
infection-inhibiting function. Lactobacilli that colonize the gastrointestinal tract or
vagina can either significantly modulate the colonic microbiota by increasing the number of
specific prebiotic bacteria such as lactobacilli and bifidobacteria or reducing undesired
intestinal colonization of pathogenic bacteria. Prebiotic like Fructooligosaccharide (FOS) is
known to promote growth of normal healthy flora like lactobacilli (LAB). FOS supplementation
in early pregnancy improves vaginal or gut microflora with LAB , which will control GU
infection and improve pregnancy outcome and promote infant's growth and development
Medical research over the last ten years has identified genitourinary (GU) infection, as a
major risk factor for low birth weight deliveries affecting a very large number of women both
in the industrialized and the developing world. It is estimated that up to about 1 billion of
women are affected annually by urinary infections worldwide. Urinary tract infections (UTI)
are also most common bacterial infections during pregnancy. In Bangladesh, there was a high
incidence of UTI in 21-25 years age group (44.61%). The bottom line for GU infection is that
lactobacilli, healthy bacteria lose their dominant.
The role of normal vaginal micro-biota in urogenital health Recently, the protective role of
the commensal microbiota has come into focus for its infection-inhibiting function.
Lactobacilli are now the favourite probiotic ("health promoting") bacteria. There are
clinical evidence to show that Lactobacillus strains GR-1 and RC-14 were shown to reduce UTI,
BV and infections associated with yeast pathogens.
Fructoligosacharride, a prebiotic agent At present, considerable attention is focused on
determining ways to increase the number of probiotic microorganisms including lactobacilli
that colonize the gastrointestinal tract or vagina. Prebiotics are substances that can either
significantly modulate the colonic microbiota by increasing the number of specific probiotic
bacteria such as lactobacilli and bifidobacteria or reducing undesired intestinal
colonization of pathogenic bacteria by mimicking their attachment sites on the intestinal
mucosa.
Design and methods In a, double- blind, placebo- controlled study, 210 early pregnant
community women (6-12 weeks gestation) will be randomized to either FOS or placebo,
administered orally, 6g/day for 6 months. Vaginal smear and urine samples will be followed
for LAB using Nugent's score and to exclude UTI respectively. Birth events including weight
will be documented. Stool or nasopharyngeal samples from their infants will be obtained at
week-24, 30, and 36 to see levels of LAB. Anthropometry and diseases morbidity will be
monitored during infancy.
Outcome measures/variables:
- Primary: 1. Incidence of LBW (birth weight below 2500 gram)
- Secondary 1. Rate of vaginal and intestinal colonization of LAB and/or GU infection at
week 12, 24, 36 gestation and gain in z-score (weight for height, weight for age and
height for age) of infant from birth
;