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CTRI Number  CTRI/2024/09/073839 [Registered on: 12/09/2024] Trial Registered Prospectively
Last Modified On: 10/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic
Preventive
Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of use of Lactobacillus plantarum UBLP-40 in addition iron supplement on anemia in pregnant women 
Scientific Title of Study   Effect of supplementation of Lactobacillus plantarum UBLP-40 in addition to oral iron on iron status in nonanemic pregnant women with iron deficiency – a double blind placebo-controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aditi Apte 
Designation  Senior Medical Scientist  
Affiliation  KEM Hospital Research Centre Pune 
Address  Community health research unit, Room no 1, 3rd floor, Shri Vinayak Hospital, Mulewadi Road, Manchar, Pune
Room no. 201, 3rd floor, TDH Building Sardar Moodliar Road, Rasta Peth, Pune
Pune
MAHARASHTRA
410503
India 
Phone  9975950227  
Fax    
Email  aditi.apte@kemhrcvadu.org  
 
Details of Contact Person
Scientific Query  
Name  Aditi Apte 
Designation  Senior Medical Scientist  
Affiliation  KEM Hospital Research Centre Pune 
Address  Community Health Research Unit, Room no 1, 3rd Floor, Shri Vinayak Hospital, Mulewadi Road, Manchar, Pune
3rd floor, TDH Building Sardar Moodliar Road, Rasta Peth, Pune
Pune
MAHARASHTRA
410503
India 
Phone  9975950227  
Fax    
Email  aditi.apte@kemhrcvadu.org  
 
Details of Contact Person
Public Query  
Name  Aditi Apte 
Designation  Senior Medical Scientist  
Affiliation  KEM Hospital Research Centre Pune 
Address  Community Health Research Unit, Room no 1, 3rd Floor, Shri Vinayak Hospital, Mulewadi Road, Manchar, Pune
3rd floor, TDH Building Sardar Moodliar Road, Rasta Peth, Pune
Pune
MAHARASHTRA
410530
India 
Phone  9975950227  
Fax    
Email  aditi.apte@kemhrcvadu.org  
 
Source of Monetary or Material Support  
Unique Biotech, Jubilee Hills, Hyderabad, Telangana - 500033, India  
 
Primary Sponsor  
Name  Unique Biotech 
Address  Jubilee Hills, Hyderabad, Telangana - 500033, India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aditi Apte   KEM Hospital Research Centre   Community Health Research Unit - KEMHRC, 3rd floor, Shri Vinayak Hospital, Mulewadi road, Manchar - 410503
Pune
MAHARASHTRA 		 9975950227

aditi.apte@kemhrcvadu.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
KEM Hospital Research Centre Ethics Committee  Approved 
KEMHRC EC   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O990||Anemia complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Matching placebo   Placebo sachets will be administered as stick packs, one stick pack per day one hour before meals for 12 weeks  
Intervention  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) for 12 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Mean change in ferritin levels as compared to baseline
2. Mean change in total hemoglobin as compared to baseline
 		 at the end of 12 weeks on intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in hemoglobin levels   35 weeks of gestation 
Mean change in ferritin levels   35 weeks of gestation  
Mean change in reticulocyte hemoglobin levels  at the end of intervention and 35 weeks of pregnancy.  
4. Proportion of participants with iron deficiency, anemia and iron deficiency anemia   at the end of the intervention and 35 weeks of gestation  
Mean change in RBC and reticulocyte indices   at the end of the intervention and 35 weeks of gestation  
Change in gut microbiome will be estimated using 16sRNA analysis in the subgroup  at the end of the intervention  
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The primary objective of the study is to evaluate the effect of 12 weeks supplementation of L plantarum UBLP-40 supplementation combined with oral IFA supplementation as compared to IFA alone on ferritin levels in non-anemic pregnant women with iron deficiency during second trimester. Age-eligible pregnant women will be identified from the affiliated antenatal facility and will be approached for participation in the study. Initially, capillary hemoglobin level will be measured using Hemocue method. Those with Hb>=11 gm% will be invited to the study clinic for further screening. During the screening visit, a blood sample of 5 ml will be collected for estimation of ferritin and CRP levels. Those eligible for participation will be consented for the main study and will be randomized to receive either test or placebo intervention for a period of 12 weeks. The field team will be responsible for monitoring of compliance and collection of adverse events if any. Blood samples will be collected at the end of the intervention and at 35 weeks to assess hematological outcomes (hemoglobin, ferritin and CRP).  A telephonic follow-up will be done during postpartum period to note the birth outcome. In a sub-sample of 15 participant per group, fecal samples will be collected for assessment of gut microbiome before and at the end of the intervention.  
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