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Prebiotic in Preventing Low Birth Weight

Primary Purpose

Birth Weight <2500gm, Genitourinary Tract Infection

Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Fructooligosaccharide
Pocari-Sweat
Sponsored by
International Centre for Diarrhoeal Disease Research, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Birth Weight <2500gm

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:(i) Age: 18-35 years (ii) Missed period : 6-12 weeks (iii) Positive pregnancy test by dip stick method in a morning urine sample (iv) Parity: any but with history of previous normal delivery (v) Weight: Body Mass Index greater than 18.5 but less than 35 (vi) Past obstetric history: Uncomplicated pregnancy, unremarkable medical and obstetric Conditions. (vii) Written informed consent witnessed by husband or legal guardian (thumb impression for those who are illiterate)

Exclusion Criteria:

Exclusion criteria The exclusion criteria will be (i) known previous H/O gestational diabetes and pre-eclamptic toxaemia (PET), (ii) any systemic disorder or chronic illness (iii) history of previous major gynaecological problem or treatment i.e., myomectomy, hysterotomy, knife cone biopsy etc.

(iv) uterine/vaginal abnormality or (v) 3 or more previous consecutive spontaneous abortions and no subsequent non vaginal delivery, etc.).

(vi) Hb level ( < 7 gm/dL), and/or oedema (vii) History of taking antibiotic within 3 weeks prior to this study (viii) Complications in previous pregnancy (stillbirth, preterm labour, complicated instrumental delivery, retained placenta, 3°/ 4° perineal tear, transverse lie, placental abruption, Previous baby of <2.5 kg / >4.5 kg) (ix) Women unwilling to comply with study protocol (x) Presence of UTI or bacteriuria in a morning mid stream fresh urine sample (xi) Presence of abnormal vaginal flora (Nugent score >7) (xii) History of irregular bleeding due to injectable Depo-Provera

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Sites / Locations

  • Shafiqul Alam Sarker

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fructooligosaccharide

Pocari-Sweat

Arm Description

One kind of prebiotics agent 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 produced isotonic solution by Otsuka Pharmaceutical Co., Ltd., Tokyo,Japan

Outcomes

Primary Outcome Measures

1. Infant birth weight
Normal Birth Weight is equal or more than 2500 gm and low birth weight is less than 2500gm
Gestational age
Gestational age measured in weeks from the first day of women's Last menstrual period to the current date. Delivery before 36 weeks of pregnancy will be considered as premature

Secondary Outcome Measures

Vaginal colonization of Lactobacillus (LAB)
Collection of vaginal swab to see colonization of LAB and also Nugent score Nugent score less than 7 indicate normal condition and equal or more than 7 indicates Bacterio-vaginal infection
Intestinal Colonization of LAB
Collection of stool to see colonization of LAB
Rate of Genito-urinary (GU) infection
Collection of urine for culture to see any infection. If bacterial colony count >10to the power 5 indicates genito urinary infection
Gain in Z-score of infant from birth
According to WHO weight for length and weight for age (50th percentile) reference table
Incidence of Acute respiratory infection and diarrhoea
Fever, cough, respiratory distress,chest indrawing etc and passsage of loose stool

Full Information

First Posted
March 14, 2016
Last Updated
March 9, 2019
Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators
Karolinska Institutet, Swedish International Development Cooperation Agency (SIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02721225
Brief Title
Prebiotic in Preventing Low Birth Weight
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators
Karolinska Institutet, Swedish International Development Cooperation Agency (SIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 (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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birth Weight <2500gm, Genitourinary Tract Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fructooligosaccharide
Arm Type
Active Comparator
Arm Description
One kind of prebiotics agent 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"
Arm Title
Pocari-Sweat
Arm Type
Placebo Comparator
Arm Description
Commercially produced isotonic solution by Otsuka Pharmaceutical Co., Ltd., Tokyo,Japan
Intervention Type
Dietary Supplement
Intervention Name(s)
Fructooligosaccharide
Intervention Description
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"
Intervention Type
Dietary Supplement
Intervention Name(s)
Pocari-Sweat
Intervention Description
Commercially used isotonic solution produced by Otsuka Pharmaceuticals Co. Ltd., Tokyo, Japan.
Primary Outcome Measure Information:
Title
1. Infant birth weight
Description
Normal Birth Weight is equal or more than 2500 gm and low birth weight is less than 2500gm
Time Frame
just after birth
Title
Gestational age
Description
Gestational age measured in weeks from the first day of women's Last menstrual period to the current date. Delivery before 36 weeks of pregnancy will be considered as premature
Time Frame
upto 40 weeks of pregnancy
Secondary Outcome Measure Information:
Title
Vaginal colonization of Lactobacillus (LAB)
Description
Collection of vaginal swab to see colonization of LAB and also Nugent score Nugent score less than 7 indicate normal condition and equal or more than 7 indicates Bacterio-vaginal infection
Time Frame
at 12, 18 and 30 weeks of gestation
Title
Intestinal Colonization of LAB
Description
Collection of stool to see colonization of LAB
Time Frame
at 12, 24 and 36 weeks of gestation from pregnant women and at birth from the infant
Title
Rate of Genito-urinary (GU) infection
Description
Collection of urine for culture to see any infection. If bacterial colony count >10to the power 5 indicates genito urinary infection
Time Frame
at 12, 18, 24 and 36 weeks of pregnancy
Title
Gain in Z-score of infant from birth
Description
According to WHO weight for length and weight for age (50th percentile) reference table
Time Frame
from birth to 3 months of age of infant
Title
Incidence of Acute respiratory infection and diarrhoea
Description
Fever, cough, respiratory distress,chest indrawing etc and passsage of loose stool
Time Frame
From birth to 3 months of age

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:(i) Age: 18-35 years (ii) Missed period : 6-12 weeks (iii) Positive pregnancy test by dip stick method in a morning urine sample (iv) Parity: any but with history of previous normal delivery (v) Weight: Body Mass Index greater than 18.5 but less than 35 (vi) Past obstetric history: Uncomplicated pregnancy, unremarkable medical and obstetric Conditions. (vii) Written informed consent witnessed by husband or legal guardian (thumb impression for those who are illiterate) Exclusion Criteria: Exclusion criteria The exclusion criteria will be (i) known previous H/O gestational diabetes and pre-eclamptic toxaemia (PET), (ii) any systemic disorder or chronic illness (iii) history of previous major gynaecological problem or treatment i.e., myomectomy, hysterotomy, knife cone biopsy etc. (iv) uterine/vaginal abnormality or (v) 3 or more previous consecutive spontaneous abortions and no subsequent non vaginal delivery, etc.). (vi) Hb level ( < 7 gm/dL), and/or oedema (vii) History of taking antibiotic within 3 weeks prior to this study (viii) Complications in previous pregnancy (stillbirth, preterm labour, complicated instrumental delivery, retained placenta, 3°/ 4° perineal tear, transverse lie, placental abruption, Previous baby of <2.5 kg / >4.5 kg) (ix) Women unwilling to comply with study protocol (x) Presence of UTI or bacteriuria in a morning mid stream fresh urine sample (xi) Presence of abnormal vaginal flora (Nugent score >7) (xii) History of irregular bleeding due to injectable Depo-Provera -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shafiqul A Sarker, MD, PhD
Organizational Affiliation
International Centre for Diarrhoeal Disease Research, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shafiqul Alam Sarker
City
Dhaka
ZIP/Postal Code
1212
Country
Bangladesh

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Prebiotic in Preventing Low Birth Weight

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