Therapeutic Synergy of Probiotic Augmented Conventional Antidiabetic Pharmacotherapy in Gestational Diabetes Mellitus
1 other identifier
interventional
200
1 country
1
Brief Summary
- 1.To compare the effects of metformin, insulin, and their combination with multistrain probiotics on glycemic control and insulin resistance in women with gestational diabetes mellitus (GDM), assessed by FPG, HbA1c, fasting insulin, and HOMA-IR.
- 2.To compare the effects of metformin, insulin, and their combination with multistrain probiotics on inflammatory biomarkers in women with GDM.
- 3.To determine the effect of multistrain probiotic supplementation alongside standard therapy on maternal and neonatal outcomes, including gestational age at delivery, mode of delivery, birth weight, Apgar score, and NICU admission.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2026
CompletedFirst Posted
Study publicly available on registry
June 12, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
Study Completion
Last participant's last visit for all outcomes
June 1, 2027
June 12, 2026
June 1, 2026
11 months
June 8, 2026
June 8, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Fasting blood glucose levels
A fasting blood sugar level measures the amount of glucose in blood after patient has not eaten for at least 8 hours. It is primarily used to screen for or monitor prediabetes and diabetes. Fasting glucose is categorized as follows: Normal: Less than 100 mg/dL (5.6 mmol/L), Prediabetes: 100 to 125 mg/dL (5.6 to 6.9 mmol/L), Diabetes: 126 mg/dL (7.0 mmol/L) or higher on two separate tests.
12 week
Fasting Serum Insulin Levels
A serum fasting insulin test measures the amount of insulin in patient's blood after an overnight fast. It is used to evaluate pancreatic function, investigate hypoglycemia, and identify early-stage insulin resistance.Standard Lab Range: 2 to 25uIU/mL. Interpretation: High Levels (Hyperinsulinemia): Usually indicate insulin resistance, where cells do not respond properly to insulin, forcing the pancreas to produce excess amounts. It can precede prediabetes and Type 2 diabetes by years, even when blood sugar remains normal. Other causes include obesity, polycystic ovary syndrome (PCOS), and Cushing's syndrome.Low Levels: Suggest impaired or destroyed insulin-producing pancreatic beta cells. Common causes include Type 1 diabetes, chronic pancreatitis, or advanced Type 2 diabetes where the pancreas is "burned out"
12 week
Homeostatic Model Assessment of Insulin Resistance
It is a widely used medical tool that estimates how effectively your body regulates blood sugar. It acts as an indirect, highly accessible indicator of insulin resistance, helping assess the risk of type 2 diabetes and metabolic syndrome. Interpretation: Optimal / Sensitive: Under 1.0. Your body is highly sensitive to insulin and manages glucose well.Early Insulin Resistance: 1.0 to 2.9 (or greater than 1.9, depending on the diagnostic criteria). Your body is starting to require more insulin to keep blood sugar stable.Significant Insulin Resistance: Above 2.9 (or as low as 2.5 for some populations, particularly in Asian demographics)
12 week
Glycated Hemoglobin
Glycated hemoglobin (HbA1c) is a blood test that measures your average blood sugar levels over the past 2 to 3 months. It checks how much sugar has bonded to your hemoglobin, and is primarily used to diagnose prediabetes and diabetes, Below 5.7%: Normal / Healthy 5.7% to 6.4%: Prediabetes 6.5% or higher: Diabetes (diagnosed on two separate tests)
12 week
Secondary Outcomes (11)
High-sensitivity C-reactive protein
12 week
Neutrophil-to-Lymphocyte ratio
12 week
Adiponectin
12 week
fetal Abdominal Circumference
12 week
thickness of placenta
12 week
- +6 more secondary outcomes
Study Arms (4)
GRP 1 Tab metformin
ACTIVE COMPARATORGRP 2 Inj insulin
ACTIVE COMPARATORGRP 3 Tab metformin + HI flora sachet
EXPERIMENTALGRP 4 Inj insulin + HI flora
EXPERIMENTALInterventions
Inj insulin s/c BD + HI flora sachet OD for 12 weeks
Tab metformin 500 mg TDS + HI flora sachet OD for 12 weeks
Eligibility Criteria
You may qualify if:
- Pregnant women (18-45 years of age).
- Diagnosed with GDM between 18-26 weeks of gestation.
You may not qualify if:
- Pre-existing diabetes mellitus.
- Pregnancy induced hypertension.
- Chronic gastrointestinal, hepatic, or renal disease.
- Use of antibiotics or probiotics within the previous 4 weeks.
- Multiple pregnancy.
- Pregnancy with known fetal anomalies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pakistan Railway Hospital
Rawalpindi, Punjab Province, 46000, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jawaria Iftikhar, phd*
Riphah International University
- STUDY DIRECTOR
Akbar Waheed, PHD
Riphah International University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2026
First Posted
June 12, 2026
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
June 12, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share