Phase 2 Study to check the Effectiveness & Safety of Probiotics in Healthy people

A prospective, interventional, randomized, double blind, parallel group, placebo controlled clinical study to evaluate the efficacy & safety of ProbioSEB CSC3™ (Bacillus coagulans LBSC plus Bacillus subtilis PLSSC plus Bacillus clausii 088AE) in immunomodulation in healthy adults - NA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/01/048913

Enrollment

Registered

2023-01-11

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

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

Conditions

None listed

Interventions

Intervention1: ProbioSEB CSC3™(Bacillus clausii 088AE plus Bacillus coagulans LBSC plus Bacillus subtilis PLSSC is formulated as an oral capsule.: One capsule twice a day for 35 days Control Intervent

Eligibility

Inclusion criteria

Inclusion criteria: 1) Male/female healthy individuals aged 18-65 years at the time of consent. 2) Individuals who are literate and who are willing to give voluntary written informed consent.

Exclusion criteria

Exclusion criteria: "1) History of consumption of drugs or dietary or probiotic supplements related to immune function within two weeks prior to screening; 2) Known case of hypersensitivity to the study product; 3) Known case of hypertension, diabetes mellitus; any history/presence of significant metabolic or autoimmune disease 4) History/presence of acute or chronic disorders of cardiac, liver, kidney, or gastrointestinal system within last 6 months from screening; 5) History/presence of any other acute or chronic disease requiring treatment condition, in the opinion of the investigator, which could jeopardize the study outcome; 6) Females who are breast-feeding/ pregnant, or intend to become pregnant during the study. "

Design outcomes

Primary

Measure	Time frame
Change in score of Wisconsin Upper Respiratory Symptom Survey (WURSS) – Daily Symptom Report from baseline to end of studyTimepoint: Day1, Day 35,Day 56	—

Secondary

Measure	Time frame
Percentage of subjects with adverse events from baseline to end of study Number and percentage of subjects with change in vital signs from baseline to end of study Number and percentage of subjects with change in clinical laboratory parameters from baseline to end of study Change in HRQoL score (PHQ15 plus SF 20) from baseline to end of study Percentage of subjects who are able to tolerate the study product at the end of the studyTimepoint: Day1, Day35, Day 56	—

Measure

Time frame

Percentage of subjects with adverse events from baseline to end of study Number and percentage of subjects with change in vital signs from baseline to end of study Number and percentage of subjects with change in clinical laboratory parameters from baseline to end of study Change in HRQoL score (PHQ15 plus SF 20) from baseline to end of study Percentage of subjects who are able to tolerate the study product at the end of the studyTimepoint: Day1, Day35, Day 56

—

Countries

India

Contacts

Public ContactMr Vairamuthu Ammaiyappan

iDD Research Solutions Pvt. Ltd.

yogesh@iddresearch.com8520082152

Outcome results