None listed
Conditions
Interventions
Intervention1: Oral IFA supplementation along with probiotic (10 billion CFU lyophilised
Lactobacillus plantarum
UBPL-40): Children of 6-59 months will be given single strain probiotic with therapeuti
Sponsors
Dr Teena Dasi
Eligibility
Inclusion criteria
Inclusion criteria: 1.Residing in the study area during the period of study 2.Individuals with febrile illnesses (except those with malaria) will be included, if the fever subsides by the time of second visit scheduled after 14 days. 3.no vitamin and mineral supplements in the previous 4weeks 4.no antibiotic treatment in the previous 4 weeks. 5.willing to refrain from using any dietary supplements during the study
Exclusion criteria
Exclusion criteria: 1.Hb=7g/dL 2.Severe underweight (Weight for age Z-score 3.Severe wasting(Weight for height Z-score 4.Any severe illness 5.Children with illnesses where iron supplementation is contraindicated (i.e. those reporting history of repeated blood transfusion, haemolytic anaemia, chronic diarrhoea, stomach ulcer, diabetes, hepatitis, hypertension, kidney diseases, heart surgeries, cancer, tuberculosis, metabolic diseases those who are on medications like tetracycline or anticoagulants. 6.Subjects taking any probiotic products, iron supplementation, or ascorbic acid supplementation during the last 4 weeks prior to the start of the intervention. 7.Subject on medications for diarrhea, constipation, heart burn or any other gastrointestinal problems. 8.Subject currently taking laxatives or has taken laxatives within the 30 days prior to screening/ enrollment. 9.Subject currently taking antibiotics (or any drug that significantly interferes with bacterial flora) or has taken antibiotics within the 60 days prior to screening/enrolment. 10.Subject currently taking or has in the past 30 days used probiotics/prebiotics (including yogurt and lacto-fermented beverages) or any digestive enzymes [prescription or over-the-counter (OTC)]. 11.Subject having known allergy to the ingredients in the test product.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1.The differences in the iron status in both the groups at end line. 2. The differences in the estimates of fecal occult blood losses in both the groupsat end line. 3. The compliance to treatment in both the groups. 4. Prevalence of morbidities in the two groups.Timepoint: At baseline, 2 weeks, 8 weeks and endline. | — |
Primary
| Measure | Time frame |
|---|---|
| The primary outcome would be the differences in the gut microbiome and gut inflammatory marker levels in both the groups at end line. Timepoint: At baseline and endline (after 3 months of intervention) For assessing stool occult blood loss it will be additionally at 2nd week and 8 weeks. | — |
Countries
India
Contacts
Public ContactDr Santosh Kumar Banjara
ICMR-NIN
Outcome results
None listed