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Clinical trial to access change in gut immunity of healthy subjects for efficacy and safety of formulation (s).

A double blind, randomized, prospective clinical trial to evaluate efficacy and safety of a formulation on gut immunity of healthy subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/013813
Enrollment
250
Registered
2018-05-11
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: Prebiotic 2: Dose- Two capsules twice a day Duration- Group A- 30 days Group B - 42 days Control Intervention1: Prebiotic- 1: Dose- Two capsules twice a day Duration- Group A- 30 days G

Sponsors

ITC Life Sciences and Technology Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy subjects both male and female (non-pregnant female) gender. {As defined by medical history and physical examination} 2.Age groups: Group A- Children:8 to 13 years, Group B Adults: 18-60 years. 3.Parents or Legal Guardian willing to give consent for age Group B: 8-13 years. 4.Participants of age group 18 â?? 60 years willing to give consent. 5.Participants willing to avoid fermented foods throughout the study duration. 6.No regular use of fibre supplementation over the month prior to the screening visit 7.The subject must be able to comply with study procedures in the opinion of the investigator.

Exclusion criteria

Exclusion criteria: 1.Any gross gastrointestinal pathology. 2.Allergy or intolerance to lactose or any other food ingredient. 3.Suffering from any chronic neuroendocrine or metabolic disorders. 4.Major gastro-intestinal surgery in last 6 month 5.Have consumed prebiotics and/or probiotics, drugs that affect gastrointestinal mobility. 6.Pregnant and lactating women. 7.Drug and/or alcohol abuse. 8.Participation in another study with any investigational product within 3 months of screening. 9.Any other recent illness that may compromise the immune system.

Design outcomes

Primary

MeasureTime frame
1. Change in Fecal IgA Level 2. Change In Immune Function to Cholera Vaccine - serum IgG levelTimepoint: 1. Visit 2 and Visit 3 (Group A) Visit 2, Visit 3 and Visit 5 (Group B) 2. Visit 3 and Visit 5 (Group B)—

Secondary

MeasureTime frame
1) Change in Fecal Bifidobacteria 2) Change in lactobacilli 3) Change in Fecal calprotectin LevelTimepoint: 1. Visit 2 and Visit 3 (Group A) Visit 2, 3 & 5 (Group B) 2. Visit 2 and Visit 3 (Group A) Visit 2, 3 & 5 (Group B) 3. Visit 2 and Visit 3 (Group A) Visit 2 and Visit 5 (Group B)—

Countries

India

Contacts

Public ContactDr Devesh

IR Innovate Research Pvt. Ltd.

Devesh.kumar@innovate-research.com9971169602

Outcome results

None listed

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