A study to compare the use of prebiotics and probiotics for sugar control in patients with uncontrolled diabetes

A randomized control trial to compare the effect of prebiotics and probiotics on glycemic control in uncontrolled type-2 Diabetes Mellitus. - PreoGUD trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037340

Enrollment

150

Registered

2021-10-14

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Prebiotic rich diabetic diet: stipulated 50g of fibre ENERGY(1805K.CAL) PROTEIN(58GM) CHOLESTEROL(257GM) FAT(46GM) FIBRE(54.31GM) The patient will need to consume the said amount

Eligibility

Inclusion criteria

Inclusion criteria: Adult ( >18yrs) type 2 diabetes mellitus patients Uncontrolled diabetes (HbA1c: 7.5 - 8.5) On stable treatment for the past 3 months

Exclusion criteria

Exclusion criteria: Type 1 diabetes mellitus Elderly patients ( >65 yrs) Patients on insulin therapy Pregnant or lactating women Known macrovascular complications GI manifestations of DM autonomic neuropathy Lactose intolerance Irritable Bowel syndrome Addictions such as alcohol Diabetic ketoacidosis Hyperglycemic hyperosmolar syndrome

Design outcomes

Primary

Measure	Time frame
HbA1c levels Fasting and post-prandial sugar levels Timepoint: At recruitment After 3 months on study diet	—

Secondary

Measure	Time frame
a.Reduction in blood pressure b.Reduction in lipid levels c.Reduction in visceral fat mass d.Reduction in weight e.Change in quality of life f.Side effects and incidenceTimepoint: At recruitment After 3 months on study diet	—

Countries

India

Contacts

Public ContactDr Nittala Rhoda Faith

Christian Medical College, Vellore

ocabraham@cmcvellore.ac.in8870005828

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026