None listed
Conditions
Interventions
Intervention1: SKB_BS2074 (Bacillus subtilis 2 109 cfu/g) White crystalline free flowing Powder: twice a day for 60 days
Control Intervention1: SKB 101 (White crystalline free flowing Powder): Twice a
Sponsors
S K Biobiz Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female, aged between 18 and 50 years. 2.Female participants are either not of childbearing potential, or females of childbearing potential agree to use a medically approved method of birth control and have a negative urine pregnancy test result. 3.In good general health, as determined by medical history, laboratory analysis, and physical examination performed by the study physician. 4.Willing to provide fecal samples as per the study requirements. 5.Willing to participate voluntarily and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Women who are pregnant or lactating. 2.Subjects who are taking Antibiotic treatment. 3.Subjects suffering from Gastrointestinal disease. 4.Subjects suffering from Diabetes. 5.Subjects suffering from Chronic/iatrogenic Immunodeficiency. 6.Subjects suffering from Abnormal blood pressure. 7.Subjects who are allergic to ingredients of the study Product. 8.Subjects who are Smoker or alcoholic. 9.Subjects who have participated prior in conflicting clinical trial or have participated in the trial over the last 3months. 10.Women who are pregnant, breastfeeding, or planning to become pregnant. 11.Daily use of supplements that contain probiotics or prebiotics within 30 days prior to screening or during study. 12.Subjects with medical conditions affecting immune status e.g., rheumatoid arthritis, heart failure, hepatitis C, HIV or taking medications that may impact the immune system, such as antibiotics, antimicrobials, or probiotic sachets. 13.Any surgical treatment within the previous three months or planned during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fecal calprotectin levels from baseline to the end of the study, comparing the intervention and placebo groups. Changes in immunological markers (IgA, IgG, IgM) between baseline and study completion, comparing the intervention and placebo groups. Improvement in the patient related overall relief, assessed using Gut Health Status Questionnaire (GHSQ) and Immune status questionnaire (ISQ) score with comparative analysis between the two groups. Timepoint: Day 0; Day 30; Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs) and serious adverse events (SAEs) throughout the study duration, compared between the intervention and placebo groups. Changes in vital signs, laboratory parameters, and physical examination findings from baseline to the end of the study, analysed for differences between groups. Timepoint: Day 0; Day 30; Day 60 | — |
Countries
India
Contacts
Public ContactDivya C
BioAgile Therapeutics Private Limited
Outcome results
None listed