Health Condition 1: A09- Infectious gastroenteritis and colitis, unspecified
Conditions
Interventions
Intervention1: Bacillus clausii spores suspension (Strain AVZ 7911): Arm 1: Bacillus Clausii Containing 2x10^6 cfu for oral administration two times a day along with ORS for a period of 10 days.
Contr
Sponsors
Advenza Global limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participant with clinical diagnosis of acute diarrhea - experienced greater than or equal to 3 loose stools within 24 hours for less than 7 days. 2. Male or female adults aged between 18 to 60 years (both inclusive). 3. Patients who have not received antibiotic or probiotic treatment in the last 7 days. 4. Willingness to comply with study protocol/ written informed consent and attend all scheduled visit
Exclusion criteria
Exclusion criteria: 1. Patients with chronic or persistent diarrhea more than 7 days. 2. History of inflammatory bowel disease, irritable bowel syndrome, or other gastrointestinal disorders. 3. Patients with severe dehydration requiring intravenous rehydration. 4. Use of antibiotics, antifungals, or other probiotics within the past 7 days. 5. Patient with current use of any other probiotic supplements, antidepressants, antipsychotic or appetite suppressant medicines, or tryptophan (to aid sleep), weight altering medications including homeopathic, ayurvedic, herbal (especially St. John’s wort), Tibetan or Unani preparations, or systemic steroids (chronic use, more than 2 weeks). 6. Patients with bloody or purulent stool, with pus or mucus and severe dehydration needing hospitalization. Subjects with symptoms of septicaemia, faster heart rate and breathing, shortness of breath, sweaty or clammy skin. 7. Participants who have used kaolin, pectin, bismuth subsalicylate, racecadotril, loperamide, atropine and other anticholinergic agents within 48 hours prior to participation in this study. 8. Pregnant or lactating women. 9. Patients with a history of immunosuppressive conditions or therapy. 10. Known hypersensitivity or allergy to Bacillus clausii. 11. Refer protocol for all.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the frequency of defecation (number of stools per day). Change in the total duration of diarrhoea (in minutes) Change in Stool consistency evaluated on the basis of Bristol stool form scale. Change in Abdominal pain score evaluated on a scoring system on the basis of 5-point Likert-Type Symptom Severity Scale The use of rescue medication.Timepoint: baseline day 3, day 6, day 8 and day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in stool examination (stool fat, stool mucus, occult blood, RBC, WBC, ova and parasites in stool). 2.Proportion of participants meeting the recovery criteria, where recovery is defined as either the passage of two consecutive normal stools based on the BSFS or the absence of stool production (zero) recorded.Timepoint: 1.baseline and day 10. 2.in the 12-hour period, immediately preceding each scheduled visit assessed on Days 3, 6, 8, and 10. | — |
Countries
India
Contacts
Public ContactDr Ashwini Kumar
CliniExperts Research Services Pvt Ltd
Outcome results
None listed