Health Condition 1: R197- Diarrhea, unspecified
Conditions
Interventions
Intervention1: Bacillus clausii Spores Suspension: Orally, once a day, 30 minutes before meal for 7 days
Control Intervention1: Placebo: RO water in 5 mL: Consume orally, once a day, 30 minutes before
Sponsors
ELMED Life Sciences Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects with acute diarrhoea having more than 3 loose stools in last 24 hours 2. Subjects with diarrhoea less than 7 days 3. Subjects who agrees to participate in this trial and signs a written consent form before the test begins.
Exclusion criteria
Exclusion criteria: 1. Subjects with mucous stools or bleeding per rectum 2. Subjects who are currently receiving treatment for severe cardiovascular, immune, respiratory, hepatobiliary, renal and urinary, nervous, musculoskeletal, psychological, infectious diseases, malignant tumors, etc 3. Subjects with a history of gastrointestinal surgery 4. Subjects with a history of malignant tumor of the digestive system 5. Subjects who have within 2 weeks of Visit 1, have taken probiotics, anti-diarrhoeal medication, H2 receptor blockers, anticholinergics, gastrin receptor antagonists, prostaglandin preparations, proton pump inhibitors, gastric mucosa protectors, other drugs for the treatment of gastritis, and health functional foods related to gastrointestinal health 6. Subjects who must continuously take drugs that can cause gastritis, such as corticosteroids, non-steroidal anti-inflammatory drugs, and aspirin, during the human application test period however, low dose aspirin 100 mg per day or less is allowed for the purpose of preventing cardiovascular disease 7. Subjects with uncontrolled high blood pressure 8. Subjects who are sensitive or allergic to the food ingredients for this human application test 9. Subjects refusing to stop eating foods and functional foods that may affect digestive system symptoms 10. Subjects who are pregnant, lactating, or planning to become pregnant within 3 months. 11. Subjects who have participated in other interventional clinical trials within 3 months of visit 1, or who plan to participate in other interventional clinical trials after the start of this human trial. 12. Subjects judged by the tester to be inappropriate for this human application test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in the frequency of diarrhoeal episodes, duration of diarrhoeal episodes, consistency of stools assessed with Bristol stool form scale in symptomatic subjects in IP arm compared to placebo.Timepoint: Day 1, Day 3, Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in bbiomarkersTimepoint: Day 1, Day 3, Day 7;Mean change in the Quality of Life in IP arm compared to placebo.Timepoint: Day 1, Day 3, Day 7;Impact of the IP on gut microbiome in sub-group of subjectsTimepoint: Day 1, Day 3, Day 7 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd.
Outcome results
None listed