Prebiotic in Preventing Low Birth Weight

NCT02721225 | Completed DMC

• 1 other identifier: PR-14038
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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

Conditions

Birth Weight <2500gm; Genitourinary Tract Infection

Outcome Measures

Primary Outcomes (2)

• 1. Infant birth weight

  Normal Birth Weight is equal or more than 2500 gm and low birth weight is less than 2500gm

  just after birth

• 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

  upto 40 weeks of pregnancy

Secondary Outcomes (5)

• Vaginal colonization of Lactobacillus (LAB)

  at 12, 18 and 30 weeks of gestation

• Intestinal Colonization of LAB

  at 12, 24 and 36 weeks of gestation from pregnant women and at birth from the infant

• Rate of Genito-urinary (GU) infection

  at 12, 18, 24 and 36 weeks of pregnancy

• Gain in Z-score of infant from birth

  from birth to 3 months of age of infant

• Incidence of Acute respiratory infection and diarrhoea

  From birth to 3 months of age

Study Arms (2)

Fructooligosaccharide

ACTIVE COMPARATOR

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"

Dietary Supplement: Fructooligosaccharide

Pocari-Sweat

PLACEBO COMPARATOR

Commercially produced isotonic solution by Otsuka Pharmaceutical Co., Ltd., Tokyo,Japan

Dietary Supplement: Pocari-Sweat

Interventions

Fructooligosaccharide DIETARY_SUPPLEMENT

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"

Fructooligosaccharide

Pocari-Sweat DIETARY_SUPPLEMENT

Commercially used isotonic solution produced by Otsuka Pharmaceuticals Co. Ltd., Tokyo, Japan.

Pocari-Sweat

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• (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

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Karolinska Institutet: collaborator
• Swedish International Development Cooperation Agency (SIDA): collaborator

Study Sites (1)

Shafiqul Alam Sarker

Dhaka, 1212, Bangladesh

Location

MeSH Terms

Interventions

fructooligosaccharide

Study Officials

• Shafiqul A Sarker, MD, PhD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 29, 2016
• Study Start: June 1, 2015
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: March 12, 2019

Record last verified: 2018-08

Locations

BA (1)