Ignite Creation Date:
2024-05-06 @ 8:21 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02721225
Status:
COMPLETED
Last Update Posted:
2019-03-12
First Post:
2016-03-14
Brief Title:
Prebiotic in Preventing Low Birth Weight
Sponsor:
International Centre for Diarrhoeal Disease Research Bangladesh
Organization:
International Centre for Diarrhoeal Disease Research Bangladesh
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 216 in the worldThe 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 4461 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 infants growth and development
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 4461 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 infants 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 4461 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 6gday for 6 months Vaginal smear and urine samples will be followed for LAB using Nugents 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 measuresvariables
Primary 1 Incidence of LBW birth weight below 2500 gram
Secondary 1 Rate of vaginal and intestinal colonization of LAB andor 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
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 6gday for 6 months Vaginal smear and urine samples will be followed for LAB using Nugents 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 measuresvariables
Primary 1 Incidence of LBW birth weight below 2500 gram
Secondary 1 Rate of vaginal and intestinal colonization of LAB andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None