To study the effect of Probiotic formulation on iron absorptio

Not Applicable

• Registration Number: CTRI/2021/03/032290
• Lead Sponsor: nique Biotech Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Young women of reproductive age between 20 to 40 year with normal haemoglobin =12 g/dl and low iron stores (plasma ferritin <30 ng/ml and high-sensitive C-reactive protein (hsCRP) =5 mg/L.

2.Subject is willing and able to comply with the protocol and diet

3.Is willing to refrain from using any dietary supplements or nutritionals during the study

4.Not taking any new vitamin and/or mineral supplements for last 3 months

Exclusion Criteria

1.Subjects taking any probiotic products, iron supplementation, or ascorbic acid supplementation during the last 4 weeks prior to the start of the intervention.

2.Subjects having pregnancy or plans for pregnancy within the following 12 weeks.

3.Subject having any medical conditions

4.Subject having a history of or currently has any gastrointestinal disease or disorder or any inflammatory bowel condition such as Cohn’s disease, short bowel, ulcerative

colitis, or Irritable Bowel Syndrome (IBS).

5.Subject is lactose intolerant (self-professed or diagnosed).

6.If a subject has had any stomach or intestinal surgery (i.e. gastric bypass).

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
Serum ferritin levelsTimepoint: Baseline, 6 weeks and 12 weeks.

Secondary Outcome Measures

Name	Time	Method
1.hemoglobin, <br/ ><br>2.erythrocyte volume fraction (EVF), <br/ ><br>3.serum iron, <br/ ><br>4.total iron-binding capacity (TIBC), <br/ ><br>5.transferrin saturation, 6.reticulocytes, <br/ ><br>7.reticulocytes hemoglobin content (Ret-Hb), <br/ ><br>8.hepcidin, <br/ ><br>9.soluble transferrein receptor (sTfR) <br/ ><br>10.RBC folate and serum vitamin B12 levels <br/ ><br> <br/ ><br>Timepoint: baseline, 6 weeks and 12 weeks.