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A study done to identify the effect of iron folic acid and synbitoic supplementation in pregnant women

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. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/101715
Enrollment
60
Registered
2026-01-21
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium

Interventions

Intervention1: Iron Folic Acid Supplementation and Synbiotic supplementation: Iron(60mg) and folic acid (5mg) as per national antenatal care guidelines along with synbiotic supplementation consisting

Sponsors

Dr Balamurugan Ramadass
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
To assess the differential expression on placental miRNA profile in both groupsTimepoint: Delivery.

Secondary

MeasureTime frame
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 bloodTimepoint: 1.baseline, mid pregnancy (2nd 3rd trimester), and delivery. 2.Delivery 3.baseline and delivery.

Countries

India

Contacts

Public ContactDr Balamurugan Ramadass

AIIMS, Bhubaneswar

jayashreerathinam1998@gmail.com7397731113

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026