Health Condition 1: O990- Anemia complicating pregnancy, childbirth and the puerperium
Conditions
Interventions
Intervention1: Probiotic UBLP-40: intervention group will receive Lactobacillus plantarum UBLP-40 (10 billion CFU (1x 1010 CFU (powdered in stick packs) and 1 stick per day, one hour before a meal) fo
Sponsors
Unique Biotech
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy pregnant women aged 18-35 years of age 2. Single live fetus of 12-16 weeks of gestation (USG confirmation) 3. Hemoglobin more than or equal to 11 gm% within 15 days before the enrollment 4. Iron deficiency as demonstrated by serum ferritin levels less than 15 ng per ml or less than 30 ng per ml in case of inflammation (CRP more than or equal to 5 mg per dl) 5. Willing to stay in the study area during the study duration
Exclusion criteria
Exclusion criteria: 1. Women with significant medical co-morbidities 2. Women with bad obstetric history 3. Women who have consumed probiotic supplements within 15 days before study participation 4. Not willing to sign written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Mean change in ferritin levels as compared to baseline 2.Mean change in total hemoglobin as compared to baseline Timepoint: at the end of 12 weeks on intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in hemoglobin levelsTimepoint: 35 weeks of gestation;Mean change in ferritin levelsTimepoint: 35 weeks of gestation;Mean change in reticulocyte hemoglobin levelsTimepoint: at the end of intervention and 35 weeks of pregnancy.;4. Proportion of participants with iron deficiency, anemia and iron deficiency anemiaTimepoint: at the end of the intervention and 35 weeks of gestation;Mean change in RBC and reticulocyte indicesTimepoint: at the end of the intervention and 35 weeks of gestation;Change in gut microbiome will be estimated using 16sRNA analysis in the subgroupTimepoint: at the end of the intervention | — |
Countries
India
Contacts
Public ContactAditi Apte
KEM Hospital Research Centre Pune
Outcome results
None listed