Health Condition 1: J399- Disease of upper respiratory tract, unspecified
Conditions
Interventions
Intervention1: Test product A: ByRx powder: Mode of Usage: Oral (Dissolved in 25ml water)
Frequency: Once a day on empty stomach.
Duration of study: 14 Days
Route of Administration: Oral
Control In
Sponsors
Inzpera health Science Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 02 to 12 years (both inclusive) at the time of consent. 2) Sex: male and females. 3) Subjects having symptoms of URTI or gastro infection (dysbiosis) which includes burning sensation, bloating, nausea, altered bowel habit, digestion issues, and high tendency of falling sick, chronic fatigue, constipation, diarrhoea etc. 4) Willing to give written parental informed consent and are willing to come for regular follow-up on the study site. 5) Who commit not to use other probiotics, synbiotic, prebiotics, and anti-biotic for their child other than the test product for the entire duration of the study. 6) Subject who has not participated in a similar investigation in the past three months. 7) Willing to use test product throughout the study period 8) subject having refrigerator at home
Exclusion criteria
Exclusion criteria: 1.Subjects with suspected or confirmed organic causes of constipation (e.g., Hirschsprung s disease, hypothyroidism, structural anal anomalies). 2.Subjects with an allergic response to any prebiotic, probiotic, or synbiotic product. 3.Subjects on chronic medication (e.g., aspirin, anti-inflammatories, antihistamines, corticosteroids) that may affect study outcomes. 4.Subjects with major diseases in cardiovascular, renal, hepatic, gastrointestinal, pulmonary, or endocrine systems. 5.History of alcohol or drug addiction. 6.Subjects with a history of major gastrointestinal complications (e.g., Crohn s disease, ulcers, cancer, ulcerative colitis). 7.Subjects participating in similar trials within the last four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of the test product in terms of change in 1. diversity and richness of gut microbiome 2.faecal output ratio 3.stool based on the Bristol Stool Criteria 4. abbreviated physical examinations 5. ROME III criteriaTimepoint: On day Day 01, after product administration Day 06 and on day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess the effectiveness of the test product in terms of subject perception questionnaire from baseline before and after usage of the test product. 2.To assess the effectiveness of the test product in terms of occurrence of the adverse event after usage of the test product. Timepoint: On day Day 01, after product administration Day 06 and on day 14 | — |
Countries
India
Contacts
Public ContactMaheshvari N Patel
NovoBliss Research Private Limited
Outcome results
None listed