| CTRI Number |
CTRI/2026/01/101715 [Registered on: 21/01/2026] Trial Registered Prospectively |
| Last Modified On: |
18/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study done to identify the effect of iron folic acid and synbitoic supplementation in pregnant women |
|
Scientific Title of Study
|
A study on effect of maternal synbiotic supplementation during
pregnancy on maternal, fetal and fetomaternal interface (placenta) miRNA
profiles in women receiving IFA supplementation, a randomised controlled
pilot trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Balamurugan Ramadass |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Department of Biochemistry
All India Institute of Medical Sciences, Sijua, Patrapada,
Khordha
ORISSA
751019
India |
| Phone |
08547805341 |
| Fax |
|
| Email |
biochem_ramadass@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayashree S |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Department of Biochemistry
All India Institute of Medical Sciences, Sijua, Patrapada,
Khordha
ORISSA
751019
India |
| Phone |
7397731113 |
| Fax |
|
| Email |
jayashreerathinam1998@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Balamurugan Ramadass |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Department of Biochemistry
All India Institute of Medical Sciences, Sijua, Patrapada,
Khordha
ORISSA
751019
India |
| Phone |
08547805341 |
| Fax |
|
| Email |
biochem_ramadass@aiimsbhubaneswar.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Dr Balamurugan Ramadass |
| Address |
Department of Biochemistry
All India Institute of Medical Sciences
Sijua, Patrapada,
Bhubaneswar, Odisha
Khordha |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Balamurugan Ramadass |
All India Institute of Medical Sciences |
Department of Biochemistry
All India Institute of Medical Sciences, Sijua, Patrapada,
Bhubaneswar
Khordha
Khordha
ORISSA |
08547805341
biochem_ramadass@aiimsbhubaneswar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Iron Folic Acid supplementation alone |
Iron(60mg) and folic acid (5mg) as per national antenatal care guidelines from enrollment during pregnancy untill delivery in addition to routine antenatal care |
| Intervention |
Iron Folic Acid Supplementation and Synbiotic supplementation |
Iron(60mg) and folic acid (5mg) as per national antenatal care guidelines along with synbiotic supplementation consisting of native yogurt(100gm) and banana starch(200gm) from enrollment during pregnancy untill delivery in addition to routine antenatal care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. In their first trimester
2. Singleton pregnancy (confirmed by ultrasound)
3. On Iron and folic acid supplementation
4. Not on any probiotic supplements
5. Willing to consent
6. Available and willing to the follow-up visit. |
|
| ExclusionCriteria |
| Details |
1. Having high risk pregnancy(diabetes, hypertension, placenta previa, placental abruption, cervical insufficiency and history adverse outcomes during earlier pregnancy)
2. Known gastrointestinal diseases(chronic diarrhea, ulcerative colitis, Crohns disease)
3.Severe Anemia (Hb less than 7gm per dl
4.Any chronic disease (cardiovascular, hepatic, renal disease, COPD/chronic asthma, immune disorder)
5.Do not comply with iron supplementation.
6.Antibiotic use (oral or systemic) in the last three months.
7.Not willing/able to follow the protocol
8.Not giving consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the differential expression on placental miRNA profile in both groups |
Delivery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Changes in maternal cellular miRNA in both groups
2.Changes in umblical cord blood cellular miRNA in both groups.
3.Changes in maternal gut microbiome and diversity in both groups.
4.Correlate gut microbiome metrics with miRNA expression profile in maternal blood, placenta and cord blood |
1.baseline, mid pregnancy (2nd–3rd trimester), and delivery.
2.Delivery
3.baseline and delivery. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/02/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study is a single-centre, randomized, parallel group, active-controlled pilot trial designed to evaluate the effect of maternal synbiotic supplementation during pregnancy on maternal, fetal and fetomaternal interface (placental) microRNA (miRNA) expression profiles in women receiving routine iron and folic acid (IFA) supplementation. A total of 60 pregnant women in their first trimester will be randomly allocated in a 1:1 ratio to receive either routine IFA supplementation along with synbiotic supplementation (native yogurt and banana starch) or routine IFA supplementation alone. Participants will be followed from enrollment until delivery. Maternal blood, placental tissue, cord blood, fecal samples and breast milk samples will be collected at predefined time points to assess changes in cellular miRNA expression and maternal gut microbiome composition. The study aims to generate pilot data on the interaction between maternal nutrition, gut microbiome and epigenetic regulation during pregnancy, which may inform future larger interventional studies. |