Health Condition 1: K318- Other specified diseases of stomach and duodenum
Conditions
Interventions
Intervention1: SKB_BCL21 (Bacillus clausii 2 109 cfu/g) White crystalline free flowing Powder: twice a day for 60 days
Control Intervention1: SKB 101 (White crystalline free flowing Powder): twice a d
Sponsors
S K Biobiz Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male and female subjects aged between 18 and 60 years. 2. Subjects presenting with acute diarrhea, defined as the occurrence of three or more loose stools per day for a duration of less than 72 hours, accompanied by clinical symptoms such as bloating, abdominal pain, or other related gastrointestinal discomfort. 3. Subjects must meet the Rome IV criteria for mild to moderate IBS-D, characterized by recurrent abdominal pain occurring, on average, at least one day per week in the last three months, with symptom onset at least six months prior to diagnosis. The condition must also be associated with at least two of the following: a) Symptoms related to defecation b) Onset of symptoms associated with a change in stool frequency c) Onset of symptoms associated with a change in stool form (appearance) 4. Subjects must present with stool types classified as Type 6 or Type 7 on the Bristol Stool Chart, indicating the presence of loose or watery stools, suggestive of gastrointestinal disturbances such as diarrhea. 5. Subjects must not have any severe health conditions that could significantly affect gut health, including major gastrointestinal disorders that may confound study outcomes. 6. Subjects must demonstrate the ability and willingness to provide written informed consent for participation in the study.
Exclusion criteria
Exclusion criteria: 1.Patients requiring the use of antibiotics either in medicine form of natural e. grapefruit seed extract, olive leaf extract, oil of oregano, colloidal silver and highly concentrated garlic preparations. 2.Exercise and the use of complementary and alternative medicine for IBS symptoms (i.e. peppermint oil, cognitive behavior therapy) during the study should be maintained at the same level prior to the study. The patient will be excluded from the study if assessment by the treating investigator showed evidence for cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, head, ears, eyes, nose and throat, dermatologic/psychiatric, allergy, major surgery or other diseases as revealed by history, physical examination and existing laboratory assessments which may interfere with the administration. 3.Pregnant or lactating women. 4.Females at childbearing age will be excluded unless they are using acceptable birth control measures i.e. implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices, sexual abstinence or a vasectomized partner. 5.Patients requiring treatments with non-permitted medication i.e. 5-HT3 antagonist, spasmolytics, anticholinergics, cholestyramine, anti-flatulence agents, metoclopramide, gastric-anti secretory agents proton pump inhibitors; for indications other than Gastroesophageal Reflux Disease GERD, narcotics, anti-diarrheal drugs, and systemic steroids. 6. Patients exceeding the treatment limits of permitted medication more than 2 days per week during the study period: alginate, antacids and analgesics limited to acetaminophen less than or 1000 mg/day, acetylsalicylic acid or NSAIDS no more than 2 tablets/day), (stable dose throughout the study period, anti-depressants (must be on a stable dose 3 months), fiber supplements, psyllium hydrophilic mucilloid, gastric antisecretory agents (only for GERD patients who are on a stable dose 3 months; patients should be able to differentiate between IBS and GERD symptoms), acetylsalicylic acid less than or equal to 325 mg/day, sedatives. Deliverance medications: Mild laxatives only if necessary. Any other medications can be used without limits based on the clinical judgment of the treating investigator. 7. Being in another clinical trial 4 weeks before entering the study. 8.Constipated IBS patients. 9. IBS-Diarrhea patients with un-treated lactose intolerance. 10.10. Regular use of probiotics or using other probiotics during the study. 11. Patients are allergic to milk or soy products. 12. Patients using catheters. 13. Patients presented with rectal bleeding, weight loss, iron deficiency anemia, nocturnal symptoms and a family history of colorectal cancer, inflammatory bowel disease and celiac spruce. 14. Patients who have allergies for the active ingredients or any of the excipients 15. Patients presented with any immune-compromised condition such as AIDS, lymphoma, long term corticosteroid treatment 16. Patients presented with nausea, vomiting and fever.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the severity and frequency of abdominal pain, assessed. 2. Improvement in stool consistency as measured by the Bristol Stool Chart, with a shift towards normal stool types (Types 3 5), evaluated across both groups. 3. Improvement in patient-reported overall symptom relief, assessed using a standardized IBS symptom questionnaire, with comparative analysis between the two groups. using a validated pain intensity scale (Visual Analog Scale), comparing outcomes between the intervention and placebo groupsTimepoint: Day 1;Day 30; Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Incidence of adverse events (AEs) and serious adverse events (SAEs) throughout the study duration, compared between the intervention and placebo groups. 2. Changes in vital signs, laboratory parameters, and physical examination findings from baseline to the end of the study, analysed for differences between groupsTimepoint: Day 1;Day 30; Day 60 | — |
Countries
India
Contacts
Public ContactDivya Chandradhar
BioAgile therapeutics Private Limited
Outcome results
None listed