Prebiotic in Preventing Low Birth Weight
Condition: Birth Weight <2500gm; Genitourinary Tract Infection
MeSH terms: Birth Weight
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      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
    

Intervention name(s): Fructooligosaccharide; Pocari-Sweat
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A prebiotics defined as "selectively fermented ingredients that allow specific changes, both in the composition and/or activity in the gastrointestinal microbiota that confers benefits upon host well-being and health"; Commercially used isotonic solution produced by Otsuka Pharmaceuticals Co. Ltd., Tokyo, Japan.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention