Study of the effect of probiotic combined oral iron folic acid supplementation on iron markers and gut health in 6-59 months childre

Not Applicable

• Registration Number: CTRI/2022/10/046219
• Lead Sponsor: Dr Teena Dasi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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.Hb�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

product.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome would be the differences in the gut microbiome and gut inflammatory marker levels in both the groups at end line. <br/ ><br>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.

Secondary Outcome Measures

Name	Time	Method
1.The differences in the iron status in both the groups at end line. <br/ ><br>2. The differences in the estimates of fecal occult blood losses in both the groupsat end line. <br/ ><br>3. The compliance to treatment in both the groups. <br/ ><br>4. Prevalence of morbidities in the two groups.Timepoint: At baseline, 2 weeks, 8 weeks and endline.