Study to investigate the efficacy and safety of a probiotic named as Bacillus Coagulans BCP92 (MTCC 25460) in adults suffering from irritable bowel syndrome disease.

Phase 2

Completed

• Conditions: Health Condition 1: K588- Other irritable bowel syndrome

• Registration Number: CTRI/2023/03/051167
• Lead Sponsor: Pellucid Lifesciences Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-10-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1. Good Physical and medical condition assessed based on the patient history and physical condition.

2.Laboratory test results(complete blood count blood chemistry panel) within normal limits or considered not to be clinically significant by the investigator and negative SARS COV 2 antibody test.

3. A voluntary provided written informed consent.

4. Diagnosis of IBS based on the ROME IV criteria e.g., recurrent abdominal pain at least one day a week for the last three months, associated with two or more of the following symptoms (these should be present for the last three months, with the onset of symptoms six months before diagnosis e.g.recurrent abdominal pain at least one day a week for the last three months, associated with two or more of the following symptoms (these should be present for the last three months, with the onset of symptoms six months before diagnosis.

a. related to defecation.

b. associated with a change in stool frequency and/or

c. associated with a change in stool form (appearance)

5.Patients with any of the following forms of IBS will be included.

a. IBS-D - more than 50% of BSF type 6 and 7 stools, and less than 25% of type 1 and 2 stools.

b. IBS-C - more than 50% of BSF type 1 and 2 stools, with less than 25% of type 6 and 7 stools.

6.At least moderate symptom severity defined as an IBS-SSS score of >175 (5 items, maximum score 500).

7.The following medications are allowed during this study, provided they have been used at a stable dose and for at least 1 month prior to the study

a. Contraceptive pills or intramuscular contraceptives,

b. Hormone replacement therapy (estrogen/progesterone),

c. L-thyroxine.

d. Antidepressants at low doses (up to 25 mg of amitriptyline, nortriptyline, or selective serotonin reuptake inhibitor per day)

e. Antihypertensives at low doses (diuretics, angiotensin converting enzyme inhibitors

f. Angiotensin receptor antagonists

Exclusion Criteria

Exclusion Criteria:

Patient will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria:

1.Unclassified IBS.

2.Cardiovascular disorders: uncontrolled hypertension (blood pressure >170/100 mmHg), cerebrovascular disease.

3.Respiratory disorders (asthma, chronic obstructive pulmonary disease [COPD].

4.Hepatic impairment (including status post cholecystectomy), renal impairment, and unexplained blood biochemistry abnormalities: serum creatinine levels over twice the upper limit of normal, AST or ALT levels over twice the upper limit of normal.

5.Gastrointestinal conditions other than IBS, including clinical or endoscopic diagnosis of gastroenteritis.

6.Endocrine disorders, including diabetes mellitus (fasting blood glucose >11 mmol/L) and elevated TSH levels.

7.Severe neurological conditions, with psychosis.

8.Malignancy.

9.Pregnancy or breastfeeding.

10.Hypersensitivity to Study Product

11.Lactose intolerance.

12.The use of gastrointestinal motility stimulants or dietary fiber supplements during the 2 weeks preceding the clinical study.

13.The use of antithrombotic drugs.

14.Any surgical procedure scheduled during the clinical study.

15.Current probiotic use and refusal to undergo a 3-month washout period.

16.Antibiotic therapy during the 3 months preceding the study.

17.Being included in another clinical study during the previous 3 months.

18.History of alcohol or substance.

19.Inability to strictly adhere to the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Changes in severity of IBS symptoms using IBS Severity Scoring System. <br/ ><br>2.Improvement or worsening of IBS global symptoms using Global Improvement Scale. <br/ ><br>3.Changes in an absolute relief. <br/ ><br>4.Assessment of change in Gastrointestinal symptoms frequency assessment using <br/ ><br>DSFQ on 5-point Likert scale. <br/ ><br>5.Assessment of change in stool consistency using Bristol stool chart. <br/ ><br>6.Change in IL-6. <br/ ><br>Timepoint: Time Frame would be of 4 Weeks,8 Weeks and 12 Weeks.

Secondary Outcome Measures

Name	Time	Method
1.Change in IBS-related mental stress relief as assessed by Perceived Stress Scale <br/ ><br>(PSS). <br/ ><br>B. Anxiety levels as assessed by State-Trait-Anxiety-Inventory (STAI). <br/ ><br>C.Incidence rates of Treatment – emergent adverse events (TEAEs) and serious <br/ ><br>adverse events (SAEs). <br/ ><br>D. Self-Assessment of General Health with tolerability of IP. <br/ ><br>E. Changes in Quality of Life. <br/ ><br>F. Change in daily number of stools (stool frequency to be assessed per IBS sub-type). <br/ ><br>G. Time to complete the resolution of abdominal discomfort. <br/ ><br>H. Assessment of safetyTimepoint: Time Frame would be of 4 Weeks,8 Weeks and 12 Weeks.