None listed
Conditions
Interventions
Intervention1: IP:HT057: Dose: One Capsule (500 mg) containing 250 mg of HT057
Dosage form: Capsule
Frequency: Twice a daily after 30 mins after a meal for 8 weeks.
Route of administration: Oral
Cont
Sponsors
Syncorp Health Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female healthy individuals aged from 19-65 (both Inclusive) 2. Participants must have a BMI within the range of 18.5 to 29.9 kg per meter square. 3. Participants with GSRS, defined as a score of greater or equal to 2 to lesser than equal to 4 in the GSRS Score at screening. 4. Participants must not have consumed antibiotics, probiotics, or gastrointestinal-related supplements within the three months prior to the screening visit. 5. Those who voluntarily agree to participate and sign an informed consent form. 6. Participants must be non-smokers and must abstain from alcohol consumption. 7. Individuals without a history of chronic gastrointestinal disorders (e.g., Irritable Bowel Syndrome [IBS], Crohn s Disease, Ulcerative Colitis, etc.). 8. Individuals who have not undergone gastrointestinal surgery within the past 6 months. 9. Individuals who have not experienced frequent gastrointestinal symptoms (e.g., diarrhoea, constipation) within the past month 10. Individuals without allergies or severe intolerance to specific foods (e.g., lactose intolerance, gluten sensitivity). 11. Women who are not pregnant, breastfeeding, or planning pregnancy. 12. Individuals not regularly taking medications for chronic conditions (e.g., diabetes, cardiovascular diseases). 13. Individuals who have not experienced severe stress or significant lifestyle changes in the past month.
Exclusion criteria
Exclusion criteria: 1. Those with a history of hypersensitivity to drugs or food ingredients 2. Individuals with hypertension, diabetes, cardiovascular disease, or impaired liver or kidney function will be excluded. 3. Those with a BMI less than 18.5 kg per meter square or greater than 29.9 kg per meter square 4. Participants with GSRS, defined as a score of greater or equal to 5 to lesser than equal to 1 in the GSRS Score at screening 5. Individuals with a history of gastrointestinal disease, or who have consumed related medications or health supplements, must be excluded. 6. Those who are pregnant, Breastfeeding or Planning pregnancy women who do not agree to use contraception during the trial. 7. According to the investigators opinion, those who are deemed unable to comply with the test requirements or otherwise deemed unsuitable. 8. Individuals with chronic gastrointestinal disorders (e.g., Irritable Bowel Syndrome [IBS], Crohns Disease, Ulcerative Colitis, etc.). 9. Individuals who have undergone gastrointestinal surgery within the past 6 months. 10. Individuals experiencing frequent gastrointestinal symptoms (e.g., diarrhea, constipation) within the past month. 11. Individuals with food allergies or severe food intolerance (e.g., lactose intolerance, gluten sensitivity). 12. Individuals regularly taking medication for chronic conditions (e.g., diabetes, cardiovascular diseases). 13. Individuals who have taken antibiotics, probiotics, or gastrointestinal related supplements within the past 3 months. 14. Smokers or individuals who consume alcohol. 15. Individuals who experienced significant stress or drastic lifestyle changes within the past month. 16. Individuals who do not voluntarily agree to participate or do not provide signed informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proliferation of beneficial bacteriaTimepoint: Baseline visit 2, Visit 4,Visit 5,Visit 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Suppression of harmful bacteria Timepoint: Baseline visit 2, Visit 4,Visit 5,Visit 7;Faecal pH Timepoint: Baseline vist 2, Visit 4,Visit 5,Visit 7;Analysis of short-chain fatty acids (SCFAs) Timepoint: Baseline visit 2, Visit 4,Visit 5,Visit 7;Beta-glucuronidase activity assay Timepoint: Baseline visit 2, Visit 4,Visit 5,Visit 7 | — |
Countries
India
Contacts
Public ContactArabinda Patnaik
Syncorp Health Pvt. Ltd.
Outcome results
None listed