Prebiotic in Preventing Low Birth Weight
کلید واژه ها
خلاصه
شرح
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
تاریخ
| آخرین تأیید شده: | 07/31/2018 |
| اولین ارسال: | 03/13/2016 |
| ثبت نام تخمینی ارسال شد: | 03/21/2016 |
| اولین ارسال: | 03/28/2016 |
| آخرین بروزرسانی ارسال شده: | 03/08/2019 |
| آخرین به روزرسانی ارسال شده: | 03/11/2019 |
| تاریخ شروع مطالعه واقعی: | 05/31/2015 |
| تاریخ تخمین اولیه اولیه: | 06/29/2018 |
| تاریخ برآورد مطالعه: | 06/29/2018 |
شرایط یا بیماری
مداخله / درمان
Dietary Supplement: Fructooligosaccharide
Dietary Supplement: Pocari-Sweat
فاز
گروههای بازو
| بازو | مداخله / درمان |
|---|---|
| Active Comparator: Fructooligosaccharide 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 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" |
| Placebo Comparator: Pocari-Sweat Commercially produced isotonic solution by Otsuka Pharmaceutical Co., Ltd., Tokyo,Japan | Dietary Supplement: Pocari-Sweat Commercially used isotonic solution produced by Otsuka Pharmaceuticals Co. Ltd., Tokyo, Japan. |
معیارهای صلاحیت
| سنین واجد شرایط تحصیل | 18 Years به 18 Years |
| جنسیت واجد شرایط مطالعه | Female |
| داوطلبان سالم را می پذیرد | آره |
| شاخص | 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 - |
نتیجه
اقدامات اولیه
1. 1. Infant birth weight [just after birth]
2. Gestational age [upto 40 weeks of pregnancy]
اقدامات ثانویه
1. Vaginal colonization of Lactobacillus (LAB) [at 12, 18 and 30 weeks of gestation]
2. Intestinal Colonization of LAB [at 12, 24 and 36 weeks of gestation from pregnant women and at birth from the infant]
3. Rate of Genito-urinary (GU) infection [at 12, 18, 24 and 36 weeks of pregnancy]
4. Gain in Z-score of infant from birth [from birth to 3 months of age of infant]
5. Incidence of Acute respiratory infection and diarrhoea [From birth to 3 months of age]
