CTRI/2022/10/046219Not yet recruiting未知
Evaluation of the effects of probiotic combined oral iron supplementation on iron stores, inflammatory markers, faecal occult blood loss and gut microbiome in 6-59 months old children
Dr Teena Dasi0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •1.Hbââ?°Â¤7g/dL
- •2.Severe underweight (Weight for age Z-score <âË?â??3SD)
- •3.Severe wasting(Weight for height Z-score <-3 SD)
- •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
Investigators
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