To study the role of Probiotic HU58 on Immune Function in Healthy Human.

An Open Labeled Trial to Evaluate Role of Probiotic- HU58 on Immune Function in Healthy Human

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/12/007518

Enrollment

Registered

2016-12-01

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

None listed

Interventions

Intervention1: Probiotic Bacillus subtilis HU58 Capsules: Each capsule to be given once a day orally after food for 8 weeks. Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male and female aged 18 to 65. 2.Stable ECG. 3.Willing to give informed consent.

Exclusion criteria

Exclusion criteria: 1.Known medical history of any systemic illness. 2.ESR above 20 and suffering from any infection (local and systemic). 3.Sero positive patients. 4.Pregnancy. 5.Subjects who are on other Probiotics or prebiotics. 6.Subjects who are addicted to tobacco, alcohol. 7.Subjects who are on any current medication.

Design outcomes

Primary

Measure	Time frame
The primary objective of the study is to evaluate the role of Probiotic- HU58 on immune function in healthy humans.Timepoint: 8 weeks	—

Secondary

Measure	Time frame
Safety and tolerability; clinical variablesTimepoint: 8 weeks	—

Countries

India

Contacts

Public ContactDr Yogesh Dound

Synergia Life Sciences Pvt. Ltd.

yogesh_dound@yahoo.com02224055607

Outcome results