To determine the effect of Yakult Probiotic on the immunity of the study population.

Not Applicable

Completed

• Registration Number: CTRI/2019/01/017256
• Lead Sponsor: Yakult Honsha Co Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-12-09
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1.Resident of KEMHRC, Vadu HDSS area

2.Healthy men and women, Age between 51-60 years on the day of enrollment

3.Consented to participate.

4.Participantsâ?? willingness and ability to comply with the requirements of the protocol.

Exclusion Criteria

1.Study participants currently enrolled in other interventional trial

2.Inability to comply with the study protocol

3.Shift or late-night workers

4.Known/reported allergy or hypersensitivity to any medicines and foods (also including allergy against dairy products)

5.Known/reported severe chronic disease (e.g. cancer, malabsorption, physician ascertained malnutrition, severe chronic infection and infestation, renal, hepatic or cardiac diseases, artificial cardiac valve, COPD (chronic obstructive pulmonary disease), respiratory insufficiency)

6.History of any cancer, HIV infection, organ transplant or any other immune system disorder

7.Acute illness (moderate or severe) and/or fever (axillary temperature >= 38°C or 100.4°F) at the time of enrollment or during the 7 days prior to the enrollment. (TE)

8.Known congenital, acquired or iatrogenic immunodeficiency (e.g. HIV, chemotherapy, immunosuppression) or on immune suppressive drugs (within last six months)

9.Chronic administration (defined as more than 14 days in total) of immunosuppressant or other immune modifying drugs during the period starting six months prior to the enrollment. However, inhaled or topical steroids are allowed.

10.Known/reported severe neurological, cognitive or psychiatric diseases

11.Presence of acute/chronic stress (assessed as per the stress questionnaires)

12.Known/reported eating disorders (e.g. anorexia, bulimia)

13.Reported alcohol consumption with frequency more than once in a week and regular consumption of drug

14.Regular medical treatment including over the counter (OTC), which may have impact on the study aims (e.g. probiotics, laxatives etc.)

15.Receipt of any oral or injectable antibiotics 5 days before enrollment. (TE)

16.Study participants who are scheduled to undergo hospitalization during the study period

17.History of receipt of a blood transfusion, other blood products, or immune-globulins in month prior to enrollment.

18.Participant has any plans to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled

19.Pregnant and lactating women

20.Any condition which the investigator considers sufficiently serious to interfere with the conduct of the trial or that constitutes any risk to the participants

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The effect of Yakult probiotic drink (Yakult®) on NK cell activity in Indian adults (men and women) of age group 51-60 years.Timepoint: 8 weeks

Secondary Outcome Measures

Name	Time	Method
The effect of Yakult® on other immune parameters such as Interferon gamma cells and immunoglobulins on B cells among Indian adults (men and women) of age group 51-60 yearsTimepoint: 8 weeks