A Prospective, Parallel arm, Randomized, Double-Blind, Comparative Clinical Study to Evaluate the Efficacy and Safety of Bacillus clausii probiotic Formulation in Adult Patients with Acute diarrhea.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Change in the frequency of defecation (number of stools per day).
Study Overview
Brief Summary
A Prospective, Parallel arm, Randomized, Double-Blind, Comparative Clinical Study to Evaluate the Efficacy and Safety of Bacillus clausii probiotic Formulation in Adult Patients with Acute diarrhea. This study is a Prospective, Parallel arm, Randomized, Double-Blind, comparative clinical trial to assess efficacy, safety and tolerability of Bacillus clausii spores suspension (Strain - AVZ 7911) and Market product in the treatment of participants suffering from acute diarrhoea.Assuming 10% dropout rate, 42 study subjects (21 participants in each arm) will be enrolled in the study and randomized in 1:1 ratio.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Participant with clinical diagnosis of acute diarrhea.
- •experienced greater than or equal to 3 loose stools within 24 hours for less than 7 days.
- •Male or female adults aged between 18 to 60 years (both inclusive).
- •Patients who have not received antibiotic or probiotic treatment in the last 7 days.
- •Willingness to comply with study protocol/ written informed consent and attend all scheduled visit.
Exclusion Criteria
- •Patients with chronic or persistent diarrhea more than 7 days.
- •History of inflammatory bowel disease, irritable bowel syndrome, or other gastrointestinal disorders.
- •Patients with severe dehydration requiring intravenous rehydration.
- •Use of antibiotics, antifungals, or other probiotics within the past 7 days.
- •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).
- •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.
- •Participants who have used kaolin, pectin, bismuth subsalicylate, racecadotril, loperamide, atropine and other anticholinergic agents within 48 hours prior to participation in this study.
- •Pregnant or lactating women.
- •Known hypersensitivity or allergy to Bacillus clausii.
- •Refer protocol for all.
Outcomes
Primary Outcomes
Change in the frequency of defecation (number of stools per day).
Time Frame: baseline day 3, day 6, day 8 and day 10
Change in the total duration of diarrhoea (in minutes)
Time Frame: baseline day 3, day 6, day 8 and day 10
Change in Stool consistency evaluated on the basis of Bristol stool form scale.
Time Frame: baseline day 3, day 6, day 8 and day 10
Change in Abdominal pain score evaluated on a scoring system on the basis of 5-point Likert-Type Symptom Severity Scale
Time Frame: baseline day 3, day 6, day 8 and day 10
The use of rescue medication.
Time Frame: baseline day 3, day 6, day 8 and day 10
Secondary Outcomes
- 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)
Investigators
Dr Nishesh Jain
Chandra Laxmi Hospital